Based in Frisco, TX, 4WEB Medical manufactures orthopedic implants using proprietary Truss Implant Technology. They specialize in titanium interbody fusion devices with advanced structural designs, produced with additive manufacturing. Their product portfolio includes stand-alone truss systems for anterior and cervical spines, and lumbar spine plating solutions.
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Orthopedic Implant Manufacturers
Last updated: January 2026
This directory lists 101 orthopedic implant manufacturers across the United States, from precision-machined components to full-service implant assembly providers.
Buyers in this specialized sector are typically solving complex problems such as achieving tight geometric tolerances for articulating surfaces, ensuring optimal osseointegration through validated porous ingrowth surfaces, or managing the intricate supply chain for bio-resorbable polymer components. These challenges demand manufacturers with proven expertise in implant-grade materials and rigorous process control.
Supplier types in this space vary significantly. You'll find highly specialized contract manufacturers focused on subtractive machining (e.g., multi-axis milling of spinal fixation devices), those excelling in additive manufacturing (like Electron Beam Melting or Selective Laser Melting for custom acetabular cups), dedicated facilities for critical post-processing (such as passivation, cleaning, and sterile packaging), and fully integrated partners offering design-to-package solutions.
To engage effectively, buyers should come prepared with comprehensive design packages, clearly defined material specifications (e.g., ASTM F136 Ti-6Al-4V ELI), target regulatory pathways for their device class, and a clear understanding of their validation requirements. Suppliers, in turn, expect a readiness for extensive Design for Manufacturability (DFM) collaboration and adherence to rigorous validation protocols (IQ/OQ/PQ).
A significant trend in this category is the increasing adoption of additive manufacturing techniques, particularly for patient-specific implants and complex porous structures that promote faster bone ingrowth. This shift is driving demand for manufacturers with deep expertise in managing the unique material properties and post-processing challenges associated with EBM and SLM technologies for implantable devices.
Company Directory
101 companies nationwide
Based in Irving, TX, Acuity Surgical specializes in developing and providing a comprehensive range of spinal implant solutions. The company offers various anterior, lateral, cervical, and posterior systems, including ALIF, LLIF, ACIF, and ACDF implants, chosen by spine surgeons for their efficacy.
Based in Lake Forest, CA, AFAB Precision Machine specializes in CNC turning and milling of stainless steel, aluminum, and plastic components. Focusing primarily on Medical Device manufacturing, they are ISO 9001:2015 certified and AS9100D compliant, offering scalable production with over 40 years of experience.
Amplify Surgical, Inc. is a medical device manufacturer based in Foothill Ranch, CA, specializing in advanced spinal implant technology. They develop and deliver powerful dual-expanding implants through minimally-invasive endoscopic approaches. Their dualPortal® solution enables surgeons to perform a wider array of lumbar spine procedures, including fusions.
ARCH Medical Solutions specializes in contract manufacturing for orthopedic, spine, dental, and surgical robotics medical devices. Operating FDA-registered facilities nationwide, they produce surgical implants and instruments using high-speed CNC machines, complemented by expertise in additive medical manufacturing.
ARCH Global Precision is a contract manufacturer specializing in advanced precision machining for the medical industry. The company provides orthopedic and dental implants, instruments, and components for robotic-assisted surgical equipment and medical devices. They invest in the latest CNC technologies and experienced teams to deliver precision solutions.
Based in Irving, TX, Astura Medical develops, manufactures, and distributes medical devices for spine surgery. Their product portfolio includes the Masada MIS Modular Minimally Invasive Posterior Spinal Fixation System, cervical vertebral body replacements, lumbar interbody, and sacroiliac biologics.
Based in Carlsbad, CA, ATEC Spine, Inc. is a medical device company committed to revolutionizing spinal surgery. They develop and manufacture advanced orthopedic implants, including next-generation porous titanium interbody spacers like IdentiTi II PC. The company offers solutions for various surgical approaches and actively participates in surgeon education to redefine spine care.
Auxein, based in Doral, FL, designs and manufactures custom orthopedic, cranio-maxillofacial, and spinal implants. The company offers over 3000 medical device products, reaching 75+ countries. Auxein ensures high quality, evidenced by its US FDA 510k, CE Mark, and ISO 13485:2016 certifications for medical device production.
Based in Rosemont, IL, Avalign Technologies manufactures precision implants and instruments for orthopedic, spine, trauma, and joint replacement surgeries. They provide turnkey manufacturing, including advanced machining, porous coatings, and additive manufacturing. Avalign supports product design, prototyping, mechanical testing, and sterile packaging for medical device solutions.
Based in Pflugerville, TX, Banister Medical specializes in manufacturing surgical instruments and orthopedic implants. The company provides crucial manufacturing services for medical device companies, focusing on producing difficult-to-manufacture components with precision and expertise.
Based in Escondido, CA, C&H Machine, Inc. is an AS9100 certified and ITAR registered precision manufacturing facility. They specialize in full-service machining, including milling, turning, EDM, welding, and assembly. Working with titanium and stainless steel, they provide critical components for the medical sector, directly supporting orthopedic implant manufacturers.
Captiva Spine, Inc. is a spine device manufacturer specializing in the development of spinal implants and minimally invasive surgery (MIS) solutions. They offer products for both cervical fusions and lumbar fusions.
Based in Naples, FL, Catalyst OrthoScience specializes in developing and manufacturing innovative orthopedic solutions. The company focuses on the shoulder replacement business, creating advanced implants and systems designed to make orthopedic surgery less invasive and more efficient for patients and surgeons.
Centinel Spine is a global company focused on developing and manufacturing orthopedic implants for cervical and lumbar spinal conditions. They specialize in disc replacement technologies, including their pro disc® C and pro disc® L systems, providing solutions for spinal health.
Corentec manufactures innovative artificial joint technology, focusing on developing and producing high-quality orthopedic implants. The company is dedicated to supporting future mobility and improving the quality of life for individuals through advanced joint replacement solutions for patients.
CTL Amedica is a medical device design, development, and manufacturing company specializing in spinal fusion and fixation products. The company develops advanced spinal health solutions using exclusive bioactive osteogenic materials, including NITRO™ (Silicon Nitride), and patented innovations like TiCro® surface architecture to enhance patient outcomes.
Diamond Orthopedic manufactures innovative orthopedic fixation devices, specializing in proprietary faceted bone screws. Their FDA-cleared technology provides an improved bone/screw interface, increased fixation, and superior pullout strength. The company offers small bone, headless compression, and cannulated screw sets for use in ambulatory surgery centers.
Based in Las Vegas, NV, Extremity Medical develops novel technologies and medical devices for extremity orthopedic procedures. The company specializes in enhancing the mechanical properties of implants and devices for use in the foot, ankle, and hand. They provide innovative solutions for orthopedic surgeons.
Fabcor, a woman-owned small business in Fountain Valley, CA, specializes in custom sheet metal fabrication, precision CNC machining, certified welding, and laser cutting. They fabricate parts per print, holding tight tolerances for complex components across various materials. Fabcor serves industries including medical, pharmaceutical, aerospace, military, and defense.
Genesis Medical Plastics specializes in converting implantable PEEK and other medical polymers into stock shapes, film, prototypes, and precision machined or injection molded components. They serve medical device manufacturers, producing implantable polymer components for applications like hip joints. The company is ISO 13485:2016 certified and FDA registered.
Globus Medical, based in Carrollton, OH, manufactures orthopedic implants and integrated solutions for a range of spinal pathologies. The company develops advanced thoracolumbar stabilization implants and enabling technologies. They focus on solving unmet clinical needs for surgeons and patients by innovating and providing procedurally integrated solutions.
Based in Dallas, TX, GPC Medical USA, Inc. manufactures premium orthopedic implants for spine and trauma applications. The company provides high-quality devices including pedicle screw systems, intramedullary nailing systems, locking plates, and distal radius implants.
Based in Savannah, GA, Innomed, Inc. manufactures a diverse range of orthopedic implants. Their product portfolio includes solutions for hip, knee, revision, shoulder & elbow, small bone, trauma, and spine applications. The company supports general orthopedic surgical needs with advanced implant technology.
Johnson & Johnson MedTech innovates and provides cutting-edge implants, advanced techniques, and data-driven technologies. They specialize in orthopaedic solutions, focusing on medical devices and technology to treat health challenges.
Based in Camarillo, CA, Laube specializes in precision titanium manufacturing for the medical industry. They partner with clients to develop new orthopedic implants and scale up production of surgical tools. The company provides both prototyping and high-volume manufacturing capabilities for critical medical components.
Based in Hollywood, FL, Madison Ortho manufactures and supplies a diverse portfolio of orthopedic implants and medical devices. The company produces precise and safe products, including intramedullary nails, locking plates, spinal fixation, joint replacements, CMF systems, and external fixators, assisting orthopedic surgeons globally.
Based in Stoughton, MA, Marver Med is a contract manufacturer specializing in CNC Swiss-Screw Machine made parts. The company produces micro-precision metal and plastic components with a strong focus on medical devices, including surgical instruments and medical implants. They are experienced in manufacturing orthopedic implants and orthopedic screws, operating under ISO 13485:2016 certification.
Based in Norristown, PA, Maxx Orthopedics specializes in the design and manufacturing of a comprehensive range of orthopedic implants. The company offers customizable solutions for various needs, including Quick Recovery Solutions (QRS®) for Ambulatory Surgical Centers and advanced knee systems like the FREEDOM® TITAN™ KNEE.
Based in Eau Claire, WI, Metal Craft and Riverside provides high-quality manufacturing solutions for medical bone plates and complex components. The company specializes in precision machining, tracking designs through critical processes to ensure quality-built products. Leveraging diverse capabilities and advanced technologies, they serve the medical and aerospace industries.
Based in Dallas, TX, MedCAD specializes in patient-matched orthopedic implants and custom surgical solutions. Utilizing 3D-CAD, 3D printing, and multi-axis milling, they create personalized titanium plates, guides, splints, and models. Their services cater to CMF, orthognathic, neuro, and lower extremity reconstruction needs.
Medline Industries, LP designs and manufactures intelligently designed orthopedic implant systems. The company offers over 25 implant systems, including Nitinol implants, MIS systems, screw systems, plating systems, and orthobiologics. They provide solutions for various orthopedic procedures, featuring unique plate and screw families.
Based in Oakbrook Terrace, IL, Merete Technologies Inc. manufactures orthopedic implant solutions. They provide epiphysiodesis implants for leg length discrepancies and misalignments, alongside the OsteoBridge™ System for bone defects. Merete also offers plates and screws for various foot and ankle surgeries, including hallux valgus and rigidus indications.
MicroGroup, part of TE Connectivity, manufactures components and devices for orthopedic and other medical device OEMs. They provide advanced metal tubing, FEP heat shrink tubing, and pull wire assemblies for surgical, imaging, diagnostics, and interventional cardiovascular applications.
Norman Noble, Inc. specializes in precision titanium implant machining and laser processing for medical devices. The company provides 5-axis micro milling and turning services for orthopedic implant designs, including extremity screws, bone plates, and spine cages. They also offer solutions for nitinol implant designs, delivering products that meet stringent medical device standards.
Based in Dayton, OH, Norwood Medical specializes in manufacturing precision medtech innovations for demanding markets. With extensive experience, the company provides manufacturing services for orthopedic implants, cardiovascular, minimally invasive, and robotic-assisted surgical technologies from its advanced campus.
NuVasive, Inc., now integrated with Globus Medical, is an orthopedic implant manufacturer based in San Diego, CA. The company specializes in developing and manufacturing advanced surgical solutions, primarily spinal implants and related technologies for complex spine procedures, focusing on improving patient outcomes.
Based in San Antonio, TX, NVISION Bio Medical Technologies is a medical device and biologics company. They provide surgeons with implants and biologics, focusing on orthopedic implant devices for spine and extremities to simplify and improve surgical procedures.
Ortho Development specializes in manufacturing clinically-proven knee and hip implant solutions. Utilizing cutting-edge technology, the company develops products designed to support improved patient mobility and better surgical outcomes.
Based in Orlando, FL, Optimotion Implants, LLC designs and manufactures total knee replacement implants and surgical instrumentation. The company specializes in its OI Blue Total Knee System, tailored for younger, active patients and optimized for minimally invasive lateral approach and ambulatory care, with cemented and cementless options.
Based in Warsaw, IN, OrthoPediatrics Corp. designs and manufactures specialized orthopedic implants and fixation devices for pediatric patients. Their product line includes novel orthopedic reconstruction systems, trauma solutions, and external fixation systems, all engineered to support proper healing for young athletes and children.
Based in Woburn, MA, OSSIO Inc. manufactures advanced orthopedic implants using its proprietary OSSIOfiber® material. These bio-integrative implants securely fixate and fully integrate into native bone, eliminating permanent hardware. Their portfolio includes suture anchors, compression staples, and screws for various orthopedic applications.
Based in Morgan Hill, CA, O&Y Precision, Inc. is a quality manufacturing company specializing in machining, assembly, and production. They serve the medical industry, providing custom parts from prototyping to full production runs, including implantable devices and other components for a variety of body parts.
Paragon 28, Inc., based in Englewood, CO, manufactures orthopedic implants and comprehensive surgical systems exclusively for the foot and ankle community. Established in 2010, they provide high-quality, cost-effective solutions like plating and bone graft systems, utilizing advanced AI and 3D modeling to enhance surgical planning and patient outcomes.
restor3d specializes in personalized, 3D-printed orthopedic implants for joints including the shoulder, ankle, knee, and hip. The company leverages proprietary expertise in 3D printing of osseointegrative materials and AI-based planning tools. They provide patient-specific implants tailored to individual anatomy for optimized surgical outcomes.
Based in Bland, MO, Roberson Machine Company offers precision CNC machining, milling, turning, wire EDM, and 3D printing services. They provide comprehensive manufacturing from prototype to production for various industries, including medical devices. The company focuses on delivering high-quality, reliable, and precise components for vital parts.
Based in El Dorado Hills, CA, Shalby Advanced Technologies designs and manufactures high-quality, US FDA-approved knee and hip implants. With an end-to-end integrated manufacturing facility, the company has achieved over 120,000 implantations and zero product recalls in 32 years, serving surgeons and patients globally.
Based in Grand Rapids, MI, Shoulder Innovations manufactures advanced orthopedic implants for shoulder arthroplasty. The company specializes in the InSet® Total Shoulder System and InSet® Reverse Shoulder Arthroplasty, focusing on innovative designs for improved patient outcomes. They provide economically efficient solutions for hospitals and ASC settings.
Based in Fullerton, CA, SigmaGraft Biomaterials, Inc. manufactures high-quality biomaterials for dental and orthopedic surgical applications. The company provides innovative bone substitute products, resorbable membranes, and wound dressings designed for bone and tissue regeneration, with specific offerings for spine, sports medicine, and trauma procedures.
Based in Miami, FL, Skeletal Dynamics, Inc. is a medical device company singularly focused on designing and manufacturing orthopedic implants for the upper extremity. They provide surgeon-driven solutions for the shoulder, elbow, wrist, and hand, serving the needs of orthopedic specialists with their specialized implant offerings.
Based in Carrollton, TX, SolcoAmerica designs and manufactures surgical implants, instruments, and minimally invasive medical devices for the spine. Their product categories include cervical, thoracolumbar, kyphoplasty solutions, and biologics.
Based in Stoughton, MA, Trax Surgical Inc. manufactures bone screws and specialized instrumentation for surgical procedures. They provide orthopedic implant solutions targeting both upper and lower extremities, serving the medical device industry.
TriMed Inc. manufactures innovative orthopedic implants for a variety of upper and lower extremity fracture indications. The company specializes in redefining the treatment of periarticular fractures through Open Reduction and Internal Fixation (ORIF), offering robust soft tissue solutions and true fragment-specific fixation systems.
ulrich medical USA specializes in the design and manufacturing of advanced spinal implant technologies. Their product portfolio includes a wide range of devices such as vertebral body replacement systems, spinal fixation systems, cervical interbody devices, and titanium cages.
Based in Dayton, MN, Unity Precision Manufacturing is a contract orthopedic manufacturer. They specialize in precision-engineered orthopedic implants and surgical instruments, offering CNC machining, turning, wire EDM, and laser marking. Serving medical and commercial industries, they hold ISO 9001, 13485, and FDA certifications.
Based in Irvine, CA, United Orthopedic Corporation designs, manufactures, and distributes high-quality orthopedic implant solutions. They specialize in hip, knee, and limb salvage systems, continuously improving product development and manufacturing processes. The company provides surgical solutions for patients, surgeons, and healthcare partners.
US Titanium Industry Inc., based in Baldwin Park, CA, specializes in titanium metals. They provide fabrication, forging, and exportation services for various industries, including the medical sector, and are noted for offering forging of titanium orthopedic implants.
Based in Austin, TX, Wenzel Spine specializes in the design and manufacturing of innovative spine technologies. The company provides a portfolio of stand-alone expandable orthopedic implants, including the panaSIa SI Fusion System and VariLift®-LX SLIF devices, aimed at simplifying spine surgery for patients.
Based in San Clemente, CA, Wise Implants US manufactures Wise-DNA™ dental implants. They employ exclusive, patent-protected Ti-Wise™ Biocompatible Material, 10x less inflammatory than traditional titanium. Nano-precision additive manufactured, their implants incorporate an Alive-Inside™ Nanostructured Matrix, attracting living cells for enhanced osseointegration.
WishBone Medical, based in Warsaw, IN, develops and manufactures advanced implants for pediatric orthopedic surgeons. The company provides anatomically appropriate solutions in single-use, sterile packed procedure kits, decreasing hospital set-up time and reducing overall patient care costs for children with orthopedic issues.
Based in San Diego, CA, Xenco Medical manufactures sterile, single-use spinal implant systems. Utilizing its proprietary SETx Technology, the company develops highly reinforced composite polymer instruments and implants for cervical, lumbar, and pedicle screw procedures. This innovative approach enhances patient safety by eliminating cross-contamination and improving operating room efficiency.
Based in Belgrade, MT, Xtant Medical develops spinal implant systems and a comprehensive biologics portfolio. They provide cervical, thoraco-lumbar, and interbody spinal implants for complex, deformity, and degenerative procedures, working seamlessly with their grafts to improve patient outcomes.
Zimmer Biomet is a global medical technology company manufacturing innovative implants and digital technologies. The company provides solutions for mobility, joint health, and overall wellness, covering a wide range of patient needs from head to toe.
Based in Warminster, PA, Acrotec Medtech is a medical device contract manufacturer. The company specializes in producing efficient, innovative, and bespoke medical components, aiming to offer clients a competitive advantage. They focus on patient wellbeing and comfort in their manufacturing processes.
AMETEK Paragon Medical is a custom manufacturer and engineering partner for medical device components. They provide manufacturing solutions for innovative implant concepts, devices, and instruments. Specializing in materials like Nitinol, PEEK, stainless steel, and silicone, they serve diverse medical sectors.
Exactech, Inc. is a manufacturer of orthopedic implants and medical devices. The company manages product inquiries and quality assurance but operates without direct sales or distribution channels in the United States, likely working through partners for product delivery to healthcare providers.
Medtronic manufactures a broad portfolio of medical devices and therapies, including surgical fixation devices designed to affix prosthetic materials or approximate tissue. The company provides solutions for various surgical procedures, encompassing orthopedic and spinal applications.
Based in El Dorado Hills, CA, Shalby MedTech designs and manufactures state-of-the-art orthopedic implants. The company specializes in knee and hip systems, leveraging proven technology to restore mobility and enhance surgical precision for patients worldwide.
SpiTrex Orthopedics is a contract manufacturer specializing in medical device manufacturing for spine, trauma, and extremity implants. The company provides co-designing, engineering, machining, and additive manufacturing processes. They also offer quality and finishing services, delivering solutions with precision.
Based in Weston, FL, Stryker is a global medical technology company that directly manufactures a diverse range of products. It provides biologic solutions, spinal implants, and surgical instruments for spine procedures and various other orthopedic applications, supporting healthcare professionals with advanced medical devices.
Based in Richmond, TX, Velentium Medical is an engineering firm that designs and manufactures Class II and Class III medical devices. They transform intellectual property into safe, secure products, offering R&D, manufacturing, cybersecurity, and test systems for the medical technology industry.
Based in Torrance, CA, Advanced Orthopaedic Solutions designs and manufactures orthopedic trauma products. They offer a comprehensive range of intramedullary fixation devices, including nails, plates, and screws, plus external fixation systems. The company focuses on technologically superior products for minimally invasive surgical procedures, promoting patient healing.
Based in Fort Wayne, IN, BioPoly develops and manufactures innovative orthopedic implants using a unique biomaterial that combines hyaluronic acid and polyethylene. The company provides early-stage solutions for joint repair, aiming to restore function and improve quality of life with products for areas like the knee, radial head, and toes.
BioPro, Inc. designs and manufactures orthopedic implants and devices to alleviate pain and restore function for patients. Since 1987, the company has specialized in solutions for orthopedic conditions, including products for foot, ankle, hand, and wrist, along with various biologics.
CONMED Corporation manufactures a range of orthopedic implants, including fixation devices, plating systems, and compression hardware for orthopedic extremities. The company provides innovative solutions designed to empower healthcare providers and positively affect patient outcomes worldwide.
Based in Newbury, OH, DEM Manufacturing is an FDA-registered contract manufacturer specializing in medical device engineering, prototyping, and production. They offer turnkey product development, from design and 3D printing to injection molded components. The company provides custom solutions for diverse volumes with U.S.-based manufacturing and sourcing.
Based in Austin, TX, Ensemble Orthopedics was established in 2019. The company specializes in developing innovative, minimally-invasive and minimally-disruptive interpositional surgical solutions for orthopedic applications.
FATHOM Advanced Manufacturing, based in Hartland, WI, provides contract manufacturing services with advanced engineering and quality controls. The company has decades of experience in the medical field, producing components like medical device enclosures, surgical tools, syringes, and orthopedic implants for clients across various regulated industries.
Based in Mesa, AZ, Fusion Orthopedics develops and provides bunion correction solutions, specializing in digital implant arthroplasty. The company focuses on orthopedic implants for foot deformities, aiming to offer effective alternatives to traditional surgical methods.
Based in Austin, TX, Genesys Spine, founded in 2009, is a medical device company specializing in spinal fusion technologies. The company engineers and manufactures advanced 3D printed orthopedic implants, including cervical standalone systems and sacroiliac joint fusion products for surgical applications.
Based in Akron, OH, Metalcraft Solutions manufactures high-quality medical devices and components. The company holds ISO 13485 certification, ensuring compliance with medical device quality management system requirements. They specialize in providing precision-engineered solutions for the medical industry, including potential orthopedic implant applications.
MicroPort Orthopedics manufactures orthopedic implants, leveraging 50 years of experience. They provide innovative knee and hip replacement solutions, including robotic-assisted systems and the Evolution® medial-pivot knee. Products enhance patient outcomes, offering stability and reduced hospital stays for healthcare professionals globally.
Moseys Production Machinists offers high-precision CNC machining services, including milling, turning, and Swiss machining. They produce complex components for original equipment manufacturers and startups, serving diverse industries like medical, aerospace, defense, and automotive. The company delivers quality production manufacturing for various machined parts.
Based in San Clemente, CA, NeuroStructures is a medical device company that designs, develops, and manufactures proprietary medical device systems. They specialize in high-quality spinal implant solutions, offering products such as cervical plating, TLIF/PLIF, ALIF, MIS, and sacroiliac fusion systems for the neuro-orthopedic surgical market.
Based in Bartlett, TN, Odyssey Medical Technologies LLC specializes in the manufacture of orthopedic implants and instruments. The company holds ISO 13485 certification and FDA registration, validating its capabilities in producing high-quality medical devices for the orthopedic industry.
Based in Holt, MI, Orchid Orthopedic Solutions provides comprehensive manufacturing solutions for medical devices and orthopedic implant procedures. They serve major orthopedic markets including hip, knee, and spine reconstruction, offering services like design for manufacturing, prototyping, and full-scale production.
Based in Reno, NV, Orthopaedic Implant Company manufactures affordable, high-value orthopedic implants. They produce a range of products including ankle, hand/wrist, hip fracture, IM nails, plates and screws, sports medicine, external fixation, and cannulated screws. The company delivers quality and cost savings to healthcare providers.
Based in San Diego, CA, Orthomod is a medical device company specializing in the development of advanced structural orthopedic biomaterials. They innovate next-generation materials uniquely suited for additive manufacturing, enabling the creation of advanced orthopedic implants. Their focus is on improving patient outcomes through novel biomaterial technologies.
Based in Hawthorne, CA, Ortho-Precision Products Inc. is an ISO13485 certified contract manufacturer of surgical implants and instruments for the orthopedic industry. They support new product launches and prototype fabrication, providing cost-effective manufacturing solutions. The company emphasizes high quality, strict traceability, and flexible delivery options.
Based in Pierceton, IN, Paragon Medical is a contract manufacturer specializing in highly engineered orthopedic and spinal implants, instruments, and cases & trays. The company offers comprehensive manufacturing solutions including precision machining, additive manufacturing, and injection molding, serving the medical device industry.
Based in Redwood City, CA, Petersen Precision manufactures high-precision metal parts for medical device OEMs. The company provides extensive in-house capabilities including fine blanking, CNC machining, precision grinding, lapping, and Wire EDM. They support clients from prototype to high-volume production for complex designs requiring tight tolerances.
Based in Warsaw, IN, Premedtec is an ISO 13485 certified contract manufacturer of orthopedic devices and implants. They provide end-to-end solutions from design for manufacturability and prototyping to high-volume production, utilizing PEEK and engineered plastics, and offering sterile packaging services.
Based in Carlsbad, CA, Spinal Elements, Inc. innovates and engineers differentiated spine technologies, medical devices, and biologics for spine surgery. They offer novel and proprietary solutions, including interbodies, metal-free posterior fixation, and robust biologics, aiming to improve patient quality of life and advance care in minimally invasive spine surgery.
Based in Corona, CA, Tamshell specializes in precision medical device machining. They fabricate tight tolerance components from plastic, stainless steel, and aluminum for critical medical device systems, including those used in orthopedic applications, ensuring high quality and exact specifications.
Based in Fairborn, OH, Tangible Solutions, Inc. is an ISO 13485:2016 certified and FDA registered 3D contract manufacturer. Specializing in American-made 3D printed titanium orthopedic implants, they produce spinal implants and total joint replacement components. Capabilities include additive manufacturing, 5-axis milling, wire EDM, laser marking, and advanced finishing processes.
Based in San Diego, CA, Unified Orthopedics Inc. specializes in advancing innovation for total joint replacement. The company provides clinically proven orthopedic products, including EMPOWR Revision Knees, advanced knee cones, and dual mobility solutions, supported by expert hands-on assistance for orthopedic care.
Highridge Medical manufactures a comprehensive portfolio of orthopedic spine implants. They specialize in advanced interbody fusion and spinal fixation systems, offering products like Mobi-C® Cervical Disc and FlareHawk®. The company focuses on surgeon insight and innovation to improve patient outcomes in spinal care.
DePuy Synthes (J&J MedTech) manufactures a comprehensive range of orthopedic implants and medical devices. It specializes in solutions for joint reconstruction, trauma, craniomaxillofacial, spinal surgery, and sports medicine. The company provides advanced technologies for various musculoskeletal conditions and injuries.
Based in Austin, TX, Texas Contract Manufacturing Group (TCMG) specializes in high-precision machining for medical devices. The company offers turnkey manufacturing, fabrication, and assembly services for high-value, complex, precision machined metal components. They produce intricate parts for their B2B customers.
Vantedge Medical specializes in precision metals manufacturing for medical OEMs, producing orthopedic implants, plates, and bone screws. The company offers end-to-end metals expertise, including rapid prototyping, automated manufacturing, and precision machining services for full lifecycle device production.
Viant is a medical device design and manufacturing partner for OEMs, offering comprehensive capabilities. The company specializes in design and manufacturing for diverse medical technologies, including interventional and inhalation device solutions. Viant focuses on enhancing product quality and accelerating market entry for its MedTech clients.
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How to Choose a Company
- Verify their comprehensive ISO 13485 certified Quality Management System, specifically auditing their process for material traceability from raw billet to finished implant, and their documented post-market surveillance support protocols.
- For devices requiring biological fixation, confirm their in-house capabilities or validated partners for critical porous ingrowth surfaces, such as titanium plasma spray, trabecular metal structures via EBM/SLM, or specific surface roughening techniques.
- Assess their experience with your specific implant material, whether it's ASTM F136 Ti-6Al-4V ELI, CoCrMo, or specialized bio-resorbable polymers, and their validation protocols for these material processes including proper passivation.
- Beware of manufacturers who quote significantly lower lead times or costs by downplaying the validation requirements for First Article Inspection (FAI), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for medical devices; this often indicates a lack of experience with stringent regulatory pathways.
- For global market access, prioritize manufacturers holding MDSAP certification or demonstrating robust readiness for audits by international regulatory bodies, especially if your target markets include Canada, Brazil, Australia, or Japan.
Frequently Asked Questions
What unique surface finish and coating capabilities should I prioritize for optimal osseointegration and biocompatibility?
Beyond standard machining, look for manufacturers with validated processes for grit blasting, acid etching, or anodization to achieve specific surface roughness for bone integration. For coatings, evaluate their experience with titanium plasma spray or hydroxyapatite (HA) coatings, ensuring they can demonstrate adherence to ISO 13485 requirements for process validation, biocompatibility testing, and sterility assurance levels (SALs).
How critical is a manufacturer's experience with bio-resorbable polymer implants compared to traditional metallic designs?
Experience with bio-resorbable polymers (e.g., PLLA, PLGA) is distinct and highly critical due to unique processing challenges, degradation profiles, and stringent controls for residual monomers. It requires specialized molding, extrusion, or additive manufacturing expertise, different post-processing, and a deep understanding of shelf-life stability and degradation kinetics not typically present with inert metallic implants. Do not assume capabilities are interchangeable.
What are the key regulatory compliance differences between sourcing a Class II spinal implant versus a Class III joint replacement?
The primary difference lies in the level of regulatory scrutiny and required clinical evidence. Class III devices (e.g., total hip replacements) typically require Premarket Approval (PMA) from the FDA, involving extensive clinical trials and data, whereas most Class II devices (e.g., spinal fixation rods, plates) often qualify for 510(k) premarket notification, demonstrating substantial equivalence to a predicate device. This significantly impacts the manufacturer's required documentation, validation efforts, and overall project timeline and cost.
Beyond ISO 13485, what other quality system certifications or audits are crucial for an orthopedic implant manufacturer?
While ISO 13485 is foundational, look for direct FDA registration and demonstrated compliance with 21 CFR Part 820 (cGMP). For international sales, MDSAP certification is increasingly vital, as it streamlines audits for multiple major markets (Canada, Brazil, Australia, Japan, US). Additionally, specific customer-driven quality audits and adherence to relevant ASTM standards for implant materials and testing are non-negotiable to ensure product safety and efficacy.