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Spinal Implant Manufacturers

Last updated: January 2026

This directory lists 76 spinal implant manufacturers across the United States, from those specializing in precision machining of titanium alloys for pedicle screws to advanced additive manufacturing for porous PEEK interbody cages.

Buyers in this category are typically solving critical problems such as accelerating time-to-market for innovative spinal fusion implants, ensuring consistent quality for high-volume instrumentation sets, or developing devices with enhanced biomechanical properties through advanced surface treatments for improved osseointegration. The specific material expertise, whether in cobalt-chrome for rods or titanium for spinal plates, is paramount.

Supplier types in this space vary significantly. Some offer full-service capabilities encompassing design support, prototyping, manufacturing, and even sterilization validation. Others operate as build-to-print contract manufacturers, excelling in high-precision machining or additive manufacturing from client-provided specifications. There are also highly specialized shops focusing exclusively on critical post-processing steps like anodization, plasma spray coating, or electropolishing.

Before engaging, buyers should have their device design matured, including detailed CAD files and material specifications (e.g., Ti-6Al-4V ELI, medical-grade PEEK). Suppliers will expect a clear understanding of your regulatory strategy (e.g., specific indications for use, predicate device if pursuing 510(k)) and your quality requirements, as these dictate manufacturing processes and necessary validations from the outset.

76 companies·59 emails·67 phones

Company Directory

76 companies nationwide

Chattanooga, TN

Based in Chattanooga, TN, 3Spine specializes in developing and manufacturing advanced spinal implants. The company offers total joint replacement solutions for the lumbar spine, featuring its MOTUS system. This technology provides an alternative to traditional spinal fusion procedures, designed to alleviate leg and back pain.

Frisco, TX

Based in Frisco, TX, 4WEB Medical manufactures spinal implants using proprietary Truss Implant Technology. They produce titanium interbody fusion devices, including anterior and cervical spine truss systems. Their additive manufacturing process is designed to stimulate a mechanobiologic response, enhancing fusion.

Irving, TX

Acuity Surgical, based in Irving, TX, directly manufactures spinal implant solutions for spine surgeons. The company offers a comprehensive portfolio of products, including Ventris ALIF, Velox ACIF, Stabilis ACDF, Tera, and SagAlign systems, backed by a commitment to customer support.

Acumed LLC manufactures a range of surgical implants and instruments, with a focus on neurosurgery. Their product line features the OsteoMed DuraKnife™ dura cutting instruments, the OsteoMed Fast Flap™ neurosurgical fixation system, and Matrix Omnipore® customized surgical implants for medical applications.

Cullman, AL

Alevio Spine specializes in designing and providing spinal implants for the treatment of sacroiliac (SI) joint conditions. Their SI-Cure Implant offers compression, fixation, and fusion options for patients suffering from chronic SI joint pain, focusing on optimizing treatment outcomes with minimally invasive solutions.

Based in West Chester, PA, Altus Spine develops and manufactures medical devices for spinal correction surgery. The company specializes in innovative spinal implants, offering FDA-cleared systems like the Sochi OCT System and Monaco HA Pedicle Screw System. They are dedicated to improving patient care through advanced engineering and surgeon collaboration.

Foothill Ranch, CA

Amplify Surgical, Inc. manufactures advanced spinal implants and endoscopic surgical systems. They specialize in innovative dual-expanding implants and related platforms for lumbar spine procedures, including fusions. The company's solutions emphasize a novel two-portal endoscopic approach, providing versatile tools for spinal restoration.

ARCH Medical Solutions Corp. provides precision medical device manufacturing, specializing in engineering and production for orthopedic, spinal, and surgical robotics markets. They manufacture surgical implants and instruments using high-speed CNC machines and additive manufacturing at FDA-registered facilities across the United States.

Jacksonville, FL

Based in Jacksonville, FL, Artfx Medical manufactures spinal and trauma implants. The company specializes in producing high-quality, safe, effective, and affordable implant solutions for the healthcare industry, serving medical professionals with specialized products.

Irving, TX

Based in Irving, TX, Astura Medical develops, manufactures, and distributes advanced spinal implants and related medical devices. They specialize in systems like the Masada MIS Modular Minimally Invasive Posterior Spinal Fixation System, as well as Cervical Vertebral Body Replacement and Lumbar Interbody products, focusing on quality and surgeon inspiration.

Carlsbad, CA

ATEC Spine, Inc. manufactures next-generation porous titanium interbody spacers and advanced spinal implants. Dedicated to revolutionizing spine surgery, the company provides innovative solutions for various spinal fusion procedures, including ACDF, TLIF, and ALIF, focusing on intelligent, integrated designs.

Rosemont, IL

Based in Rosemont, IL, Avalign Technologies, Inc. provides turnkey manufacturing processes for spinal, orthopedic, trauma, and maxillofacial implants. The company specializes in precision-machined components, including porous coatings, and offers design, development, and sterile packaging services for medical devices and instruments.

Based in King of Prussia, PA, Camber Spine Technologies, LLC designs and manufactures surgeon-designed spinal implants. They specialize in MIS and minimally disruptive access solutions, offering titanium interbody cages such as SPIRA® and ENZA® for faster spinal fusion and recovery.

Jupiter, FL

Based in Jupiter, FL, Captiva Spine, Inc. manufactures spinal implants and develops minimally invasive surgical (MIS) solutions. The company specializes in devices for cervical and lumbar fusions, serving the spinal healthcare market. They are dedicated to advancing spine device technology.

Carlsbad, CA

Based in Carlsbad, CA, Carlsmed, Inc. specializes in personalized spinal solutions. The company utilizes its aprevo® platform, patient data, and digital technologies to design and manufacture customized spine fusion devices tailored for individual patients, aiming to improve surgical outcomes.

Based in West Chester, PA, Centinel Spine, LLC is a global medical device company with over three decades of experience. It exclusively focuses on developing and manufacturing cervical and lumbar spinal implants, including its pro disc® line for total disc replacement procedures.

Mobi-C Cervical Disc provides a advanced spinal implant solution for one and two-level cervical disc replacements. Backed by over a decade of clinical data, this device has demonstrated improved long-term outcomes for patients seeking alternatives to spinal fusion.

Knoxville, TN

Based in Knoxville, TN, ChoiceSpine LLC specializes in providing differentiated spine surgery systems. The company manufactures 3D printed titanium spinal fusion implants featuring its BioBond® porous trabecular structure. They also produce PEEK interbody systems, pedicle screw systems, and SI joint fixation devices for various spinal fusion procedures.

Based in New York, NY, Companion Spine develops and provides innovative spinal stabilization devices, including the DIAM™ and LISA™ implants. The company is dedicated to changing spine care for the better, enhancing its product portfolio with strategic acquisitions such as Coflex®.

CTL Amedica, based in Blue Bell, PA, designs, develops, and manufactures medical devices. Specializing in spinal health innovation, the company offers a full portfolio of spinal fusion and fixation products. They incorporate exclusive bioactive osteogenic materials and proprietary technologies like NITRO™ and TiCro® to enhance patient outcomes with advanced solutions.

Tanner, AL

Curiteva, Inc., based in Tanner, AL, specializes in manufacturing advanced 3D-printed fully porous PEEK medical spinal implants. Their Inspire Technology platform creates interconnected porous structures designed to promote osseointegration and improve patient outcomes in orthopaedics. The company offers a range of implant sizes and features for spinal fusion.

Englewood, OH

Based in Englewood, OH, C&W Swiss is an FDA-registered contract manufacturer specializing in precision medical implants for spinal, extremity, trauma, and orthopedic markets. They utilize Swiss machining for projects ranging from prototypes to large production runs, emphasizing strict quality controls on devices like bone screws and locking screws.

Elevation Spine develops spinal implants, specializing in less invasive spinal fusion technology. The company offers the proprietary SABER-C cervical fusion system, comprised of a zero-profile anterior cervical plate, titanium interbody, and fixation spikes/screws. Their advanced solutions enable surgeons to perform spinal fusion more efficiently.

Plano, TX

Based in Plano, TX, Eminent Spine manufactures advanced spinal implants and instrumentation. The company offers 3D Titanium Pedicle Screw Systems, SI joint systems, cervical implants, and lumbar systems. They focus on solid biomechanics and quality biomaterials to meet industry needs.

Austin, TX

Based in Austin, TX, Ensemble Orthopedics was established in 2019. The company specializes in developing minimally-invasive and minimally-disruptive interpositional surgical solutions for orthopedic applications.

Mountain View, CA

Based in Mountain View, CA, Expanding Innovations Inc. develops next-generation expandable interbody cage technology for spine surgeons. They offer non-screw based interbody fusion cages like X-PAC TLIF and LLIF systems, designed to mitigate post-operative vertebral body subsidence. The company also provides the X-PAC N-GAGE™ modular lumbar plate system.

Farmers Branch, TX

Based in Farmers Branch, TX, Fuse Medical is a medical device company offering a comprehensive implant portfolio for the orthopedic and spine marketplace. They are committed to advancing, preserving, and restoring anatomical motion through innovative solutions across various areas, including spine.

Carrollton, OH

Globus Medical innovates and provides a comprehensive portfolio of spinal stabilization implants and solutions for treating a range of spinal pathologies. The company offers procedurally integrated solutions paired with leading-edge enabling technologies. They actively listen to surgeons and patients, focusing on solving unmet clinical needs to improve patient care.

Dallas, TX

Based in Dallas, TX, GPC Medical USA, Inc. manufactures and supplies premium quality orthopedic implants, specializing in spine and trauma devices. The company offers products like the spine HEAL Pedicle Screw System, designed for precise segmental stabilization of the spine in adult patients.

Santa Ana, CA

Based in Santa Ana, CA, GS Medical USA manufactures a range of innovative spine implants. The company focuses on developing advanced solutions that contribute to the future of spine care, addressing various clinical needs with their specialized products for spinal health.

Salt Lake City, UT

Based in Salt Lake City, UT, Innovasis specializes in the research, development, manufacturing, and marketing of spinal implant devices. The company produces cervical, thoracolumbar, and cranial implants, incorporating advanced technologies like HA PEEK and TETRACELL for comprehensive spinal solutions.

Huntley, IL

Life Spine, Inc. specializes in manufacturing innovative spinal implant solutions designed to address spinal pathology from the occiput to the sacrum. The company develops and provides a range of FDA-cleared products, including expandable spacer systems and spinal fixation systems for various fusion procedures.

Hollywood, FL

Madison Ortho manufactures a diverse portfolio of orthopedic implants, instruments, and prostheses, including products for spinal fixation. The company provides precise and safe orthopedic solutions for surgeons globally, focusing on continuous development to meet evolving orthopedic technologies and patient needs.

Based in Stoughton, MA, Marver Med is an ISO 13485 certified contract manufacturer. They specialize in CNC Swiss-Screw machined metal and plastic parts, producing micro-precision components for medical devices. Their services include surgical instruments and various medical implants, such as spinal implants, crafted to rigorous tolerances.

Redwood City, CA

Based in Redwood City, CA, Nevro Corp. specializes in implantable medical devices. They provide the HFX™ Spinal Cord Stimulation (SCS) system, an FDA-approved solution for chronic pain, painful diabetic neuropathy, and non-surgical back pain. Nevro also offers a comprehensive product portfolio for sacroiliac (SI) joint fusion.

Noblesville, IN

Based in Noblesville, IN, Nexxt Spine, LLC designs and manufactures American-made spinal implants and instruments in-house. Their extensive product portfolio includes cervical, TLIF, ALIF, and SI systems, along with various plating and pedicle screw systems for comprehensive spinal solutions.

Atlanta, GA

NovaBone specializes in developing and manufacturing advanced biomaterials designed for bone and soft tissue regeneration. These innovative solutions support the body's natural healing process, meeting the specialized needs of dental and orthopedic surgeons. The company focuses on creating products that enhance surgical outcomes in various orthopedic applications.

San Diego, CA

Based in San Diego, CA, NuVasive, now part of Globus Medical, is a medical technology company. It specializes in spinal solutions and services, including intraoperative neuromonitoring (IONM) for surgeons and hospitals. The company is actively involved in manufacturing medical devices for spine surgery.

San Antonio, TX

Based in San Antonio, TX, NVISION Bio Medical Technologies is a medical device and biologics company. It provides surgeons with high-quality implants and biologics, specializing in spinal and extremity solutions designed to simplify and improve surgical procedures for various indications.

Oberg Industries is a global contract manufacturer specializing in precision machined and stamped metal components for the medical device market. With over 78 years of expertise, they produce high-performance, biocompatible spinal plates and other critical components. Based in Freeport, PA, Oberg serves clients from its five U.S. facilities.

Osseus Fusion Systems is a privately held medical device firm focused on offering minimally invasive spinal fusion and fixation solutions. The company develops and provides a range of spinal implants, including products across its Aries, Black Diamond, Blue Topaz, Gemini-C, Pisces-SA, and White Pearl platforms.

Norwalk, CT

Premia Spine is a medical device company specializing in the development, manufacturing, and commercialization of spinal implants. Based in Norwalk, CT, they offer innovative, minimally invasive solutions for lumbar spinal stenosis, including their proprietary TOPS™ System. The company focuses on improving patient outcomes through advanced spinal technologies.

Bland, MO

Roberson Machine Company provides precision CNC machining, milling, turning, wire EDM, and 3D printing services from prototype to production. Based in Bland, MO, they specialize in manufacturing critical components for various industries, including medical devices like spinal implants, aerospace, and automotive, utilizing materials such as stainless steel and aluminum.

Santa Clara, CA

SI-BONE provides minimally invasive surgical solutions for alleviating sacroiliac (SI) joint pain. Based in Santa Clara, CA, the company develops and manufactures the iFuse Implant System, a specialized implant designed to treat chronic low back pain originating from the SI joint.

Fullerton, CA

SigmaGraft Biomaterials, Inc. manufactures innovative biomaterials for orthopedic and dental applications. The company specializes in products for spinal surgeries, including AlloGen™ DBM, ExcellBone™ Active, and BoneSigma™, which support bone and tissue regeneration. Based in Fullerton, CA, they provide implantable solutions.

Carrollton, TX

Based in Carrollton, TX, Solco designs and manufactures surgical implants, instruments, and minimally invasive medical devices for the spine. Their product offerings encompass solutions for cervical, thoracolumbar, and kyphoplasty procedures, in addition to biologics, catering to specialized spinal care needs within the medical industry.

Overland Park, KS

Based in Overland Park, KS, Spinal Simplicity is a medical device company manufacturing innovative spinal implant solutions. They specialize in interspinous and sacroiliac (SI) fusion devices, including Minuteman, Liberty SI, Patriot SI, and Hero SI products. Their devices are designed for posterior fusion and SI joint fixation, proudly made in the USA.

Louisville, CO

Based in Louisville, CO, Synergy Spine Solutions Inc. develops advanced spinal implant solutions. Their flagship product, the Synergy Disc®, is a cervical artificial disc replacement designed to restore alignment, balance, and natural physiologic motion. This surgeon-led company is currently enrolling patients in its US IDE study.

Plano, TX

Based in Plano, TX, ulrich medical USA manufactures a comprehensive range of spinal implants and fixation systems. Their product portfolio includes universal OCT spinal fixation systems, posterior spinal fixation systems, 3D porous titanium cervical interbody devices, vertebral body replacements, and cervical plates, serving surgical stabilization requirements.

Austin, TX

Wenzel Spine, based in Austin, TX, designs and manufactures innovative spinal implants. They offer stand-alone expandable devices, like the panaSIa SI Fusion System and VariLift®-LX SLIF. With over 17 years of expertise, the company provides high-quality products to simplify spine surgery.

San Diego, CA

Based in San Diego, CA, Xenco Medical manufactures sterile-packaged, single-use spinal implant systems. Their SETx Technology utilizes highly reinforced composite polymer instruments and implants, including cervical and lumbar interbody systems and pedicle screw systems. This approach enhances surgical safety and efficiency by eliminating cross-contamination risks.

Belgrade, MT

Xtant Medical develops and manufactures a comprehensive portfolio of orthobiologics and spinal implant systems. They offer cervical, thoraco-lumbar, and interbody spinal fixation systems designed to integrate with their grafts for complex, deformity, and degenerative procedures.

Zavation designs, develops, manufactures, and distributes a comprehensive portfolio of medical device products, specifically focusing on spinal solutions. Operating its own manufacturing and R&D facilities in Flowood, Mississippi, the company provides cervical, thoracolumbar, and sacroiliac implants, along with biologics, to help surgeons treat patients.

Warsaw, IN

Zimmer Biomet is a global medical technology company providing innovative implants and digital technologies. Specializing in orthopedic solutions for enhanced mobility, joint health, and overall wellness, the company offers a comprehensive portfolio of products, including a significant focus on spinal implants, covering patient needs from head to toe.

Integra LifeSciences is a global medical technology company specializing in neurosurgical solutions, including products for dural access and repair, as well as cerebral spinal fluid management. They also develop regenerative technologies for wound reconstruction, surgical reconstruction, and advanced surgical instrumentation.

Medtronic manufactures advanced medical devices, including articulating artificial cervical discs such as the Prestige LP™. These spinal implants are designed for one- or two-level disc replacement procedures, supporting spine health and mobility.

Providence Medical Technology, Inc. develops innovative solutions and manufactures advanced implant systems for spinal care. They focus on high-risk cervical and lumbar fusion patients, including products like CORUS™ PCSS for multi-level circumferential cervical fusion procedures. Their mission is to improve clinical outcomes and establish CCF as the standard of care.

Weston, FL

Stryker is a medical technology company based in Weston, FL, specializing in products for spine procedures. The company's core technologies include biologic solutions, spinal implants, and surgical instruments designed for use in various spine surgeries and related applications.

Leesburg, VA

VB Spine, LLC is a privately held medical technology company specializing in innovative solutions for the spine industry. They offer a comprehensive product portfolio designed to address critical needs in spine surgery and enhance patient outcomes. With a global distribution network, VB Spine focuses on developing cutting-edge technologies.

Fort Lauderdale, FL

Based in Fort Lauderdale, FL, AxioMed LLC specializes in developing and manufacturing proprietary viscoelastic spinal disc replacements. Founded in 2001 by surgeons and engineers, the company offers one-piece total disc replacement devices like the Freedom® Cervical and Lumbar Discs, designed to restore normal spinal function and shock absorption.

St. Louis, MO

Based in St. Louis, MO, CoreLink designs and manufactures a broad portfolio of spinal implants and instruments. The company is vertically integrated, internally developing over 99% of its products, and utilizes advanced Mimetic Metal Technology for its spine implant systems.

Foundation Fusion Solution, LLC, operating under the CornerLoc brand, specializes in developing and manufacturing sacroiliac (SI) joint fusion solutions. The company provides systems like TransLoc 3D™ for minimally invasive SI joint stabilization, offering comprehensive options for patients with chronic SI joint dysfunction.

Baldwin, NY

elliquence designs and develops innovative medical devices and advanced Radiowave solutions for minimally invasive surgery. They specialize in neurosurgery, endoscopic spine, orthopedic, and pain management applications, offering products like Disc-FX for disc herniations. The company focuses on healthy tissue preservation and minimized patient trauma.

Fremont, CA

Based in Fremont, CA, Evolve Manufacturing specializes in producing complex medical and life sciences devices and instruments. Operating from a 75,000 sq ft facility in Silicon Valley, the company offers contract manufacturing services for sophisticated products within these critical sectors.

Austin, TX

Based in Austin, TX, Genesys Spine designs and manufactures advanced 3D printed spinal implants. They offer a range of products including cervical standalone systems and sacroiliac joint fusion solutions, focusing on engineering excellence for surgeon efficiency in spinal procedures.

Holt, MI

Based in Holt, MI, Orchid Orthopedic Solutions provides comprehensive manufacturing services for medical devices, with a strong focus on orthopedic implant procedures. Their expertise includes design for manufacturing, prototyping, and production of implants and instruments for the spine and other orthopedic markets.

Reno, NV

Based in Reno, NV, Orthopaedic Implant Co. manufactures high-value orthopaedic implants including plates, screws, and IM nails for diverse applications like ankle, hand/wrist, hip fractures, and sports medicine. The company focuses on providing cost-effective, high-quality solutions to healthcare providers and hospitals.

Tampa, FL

PainTEQ develops and provides the LINQ® Procedure, a minimally invasive solution for Sacroiliac (SI) joint dysfunction. This outpatient procedure involves an implant designed to achieve long-term fusion, addressing hypermobility and hypomobility issues.

Warsaw, IN

Based in Warsaw, IN, Precision Medical Technologies is a contract manufacturer specializing in orthopedic devices and minimally invasive surgery. They provide end-to-end manufacturing, including design for manufacturability, prototyping, and high-volume production for spinal solutions and instruments, complete with sterile packaging.

Carlsbad, CA

Based in Carlsbad, CA, Spinal Elements, Inc. designs and engineers advanced, patient-centric spine surgery technologies. They offer differentiated medical devices and biologics, including interbodies, posterior fixation systems, and biologics to address complex spine surgery challenges for surgeons and patients.

Fairborn, OH

Based in Fairborn, OH, Tangible Solutions, Inc. is an ISO 13485:2016 certified and FDA registered 3D contract manufacturer. They specialize in orthopedic implant solutions, including spinal implants and total joint replacement. The company provides end-to-end device manufacturing management and advanced additive capabilities.

Los Gatos, CA

Tenon Medical, Inc. develops the Catamaran SI Joint Fusion System, a titanium implant for less invasive sacroiliac (SI) joint fusion. The system features a single robust implant designed to facilitate authentic arthrodesis away from neural and vascular structures.

Highridge Medical provides a comprehensive portfolio of spinal implants and related technologies. They specialize in products such as interbody fusion systems, cervical discs, deformity spinal fixation systems, and allografts. The company focuses on integrating surgeon insights to drive innovation in spinal solutions.

New Brunswick, NJ

DePuy Synthes, a Johnson & Johnson MedTech company, specializes in providing comprehensive medical solutions. The company manufactures a wide array of devices and implants for spinal surgery, joint reconstruction, trauma, craniomaxillofacial, and sports medicine. They deliver innovative products designed to improve patient outcomes in complex orthopedic and neurological procedures.

San Mateo, CA

Personalized Spine specializes in developing and manufacturing patient-specific spinal implants using FDA-designated Breakthrough Technology. The company employs an AI-enabled surgical planning system to precisely design and 3D-print intervertebral fusion devices tailored to individual patient anatomy, offering a comprehensive solution for spinal fusion.

Viant partners with OEMs, offering comprehensive orthopedic design and manufacturing solutions. Leveraging 50 years of clinical excellence, the company provides manufacturing capabilities for medical technology, including spinal implants and other interventional devices, supporting complex challenges from development to production.

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How to Choose a Company

  • Verify their specific material expertise, especially for difficult-to-machine medical-grade materials like PEEK, Ti-6Al-4V ELI, or cobalt-chrome alloys, and their experience with associated tooling and processes.
  • Assess their regulatory track record beyond general ISO 13485 certification; specifically, inquire about their experience and success assisting clients with FDA 510(k) or PMA submissions for spinal devices.
  • Confirm their capabilities for critical surface finishing techniques essential for spinal implants, such as plasma spray, acid etching, or anodization to promote osseointegration, along with in-house validation processes.
  • Examine their robust design control and change management procedures, particularly how they maintain an exhaustive Device History Record (DHR) and manage revisions for implantable devices.
  • A significant red flag is a manufacturer promising unrealistically short lead times for novel spinal implants without a thorough Design for Manufacturability (DFM) review or extensive prototyping, especially if they lack a strong portfolio of prior spinal device work.
  • For complex geometries or patient-specific implants, ensure the manufacturer has validated additive manufacturing (3D printing) capabilities for medical-grade titanium or PEEK, and can demonstrate process control for porosity and mechanical properties.
  • Evaluate their in-house metrology and quality control processes to ensure they can verify critical features specific to spinal implants, such as thread forms on pedicle screws, intricate lordotic angles on interbody cages, or specific surface roughness for tissue ingrowth.

Supplier Types at a Glance

TypeBest ForTypical MOQ
Full-Service InnovatorsStartups or companies developing novel spinal implants needing design support, DFM, prototyping, and regulatory pathway guidance.Low for prototypes (1-10 units), scalable to commercial volumes (500-5000+ units)
Precision Build-to-Print SpecialistsEstablished companies with mature, validated designs for high-volume production of specific components like pedicle screws or plates.Medium to High (100-10,000+ units)
Additive Manufacturing (AM) ExpertsDesigns requiring complex porous structures, patient-specific implants, or rapid iteration of titanium or PEEK devices.Varies (1 to 1,000+ units depending on complexity)
Surface Treatment & Finishing HousesManufacturers needing specialized post-processing for osseointegration (e.g., plasma spray, acid etching) on components from other sources.Flexible (batch processing)

Frequently Asked Questions

How do I vet a spinal implant manufacturer's experience with 510(k) or PMA submissions?

Ask for references from previous clients who have successfully achieved 510(k) or PMA clearance with the manufacturer's products. Inquire about their direct involvement in providing documentation, testing data, and quality system support specific to these regulatory pathways, rather than just manufacturing components. Their understanding of predicate devices and substantial equivalence for 510(k) is crucial.

What's the difference in supplier capabilities for PEEK-based versus titanium-based spinal implants, and why does it matter?

PEEK requires specialized machining expertise to prevent heat-related material degradation and achieve precise geometries, often involving specific tooling and cooling strategies. Titanium (Ti-6Al-4V ELI) requires different machining parameters, and often more extensive post-processing for surface treatments like plasma spraying or acid etching for osseointegration. A manufacturer's core competency in one material doesn't automatically translate to the other, impacting quality and cost.

How crucial is a manufacturer's expertise in specific surface treatments for promoting osseointegration?

It is extremely crucial. The surface characteristics of a spinal implant directly influence its biological response and long-term success. Manufacturers with expertise in specific surface treatments (e.g., rough sandblasting, acid etching, porous coating through additive manufacturing or plasma spray) can optimize the implant's interaction with bone, accelerating osseointegration and potentially improving clinical outcomes. Validate their in-house capabilities and process validation data for these treatments.

What kind of traceability and UDI capabilities should I expect from a spinal implant manufacturer?

You should expect robust Unique Device Identification (UDI) marking capabilities (e.g., laser etching) that comply with global regulatory requirements. Beyond that, a strong manufacturer will have a comprehensive lot traceability system, linking every raw material batch, process step, and sterilization cycle to individual devices, ensuring a complete Device History Record (DHR) from raw material to finished product, essential for recalls or audits.

Can a contract manufacturer assist with Design for Manufacturability (DFM) specifically for spinal fusion devices?

Yes, the best contract manufacturers for spinal implants offer DFM consultation. Their engineering teams, experienced with the nuances of PEEK machining or titanium forming, can provide invaluable feedback on your design. This can optimize the manufacturing process, reduce costs, improve yield, and potentially enhance the device's functional performance, especially for complex geometries or features like lordotic angles in interbody cages.

What are the key considerations for protecting my intellectual property (IP) when working with a third-party spinal implant manufacturer?

Ensure a robust Non-Disclosure Agreement (NDA) and a Manufacturing Services Agreement (MSA) are in place, clearly defining ownership of design IP, tooling, and manufacturing process IP. Verify their internal security protocols for data, facility access, and employee agreements. For novel devices, consider whether the manufacturer has a history of developing competing products, and prioritize those with clear IP separation policies.

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