--- title: "Orthopedic Devices, Definition | MedTech Terms" description: "Implants and instruments for bone, joint, and spine conditions. Plain-English Market Segments definition for MedTech teams, with examples and related terms." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/orthopedics#term", "name": "Orthopedic Devices", "description": "Orthopedic devices include hip, knee, and shoulder reconstruction implants, spine fusion hardware, trauma plates and screws, sports medicine soft-tissue repair, and orthobiologics. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Market Segments](/terms?cat=Market%20Segments) 6. / 7. Orthopedic Devices [All terms](/terms) Market Segments [Strategic Landscape](/ecosystems/strategic-landscape) # Orthopedic Devices Implants and instruments for bone, joint, and spine conditions. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Orthopedic devices include hip, knee, and shoulder reconstruction implants, [spine](/terms/spine) fusion hardware, trauma plates and screws, sports medicine soft-tissue repair, and orthobiologics. Robotics-assisted surgery is an increasingly important sub-segment. What the regulation says Orthopedic devices are considered medical devices by regulatory bodies like the FDA and the European Union, falling under specific classifications based on their [intended use](/terms/intended-use) and risk. For example, in the US, many orthopedic implants are classified as Class II or Class III devices under 21 CFR Part 888, requiring premarket notification (510(k)) or [premarket approval](/terms/pma) (PMA) respectively. The EU [MDR](/terms/mdr-reporting) (Regulation (EU) 2017/745) also categorizes these devices based on risk, with most orthopedic implants falling into higher risk classes (e.g., Class IIb or Class III), necessitating extensive clinical evaluation and conformity assessment. ## What this means in practice Stryker, Zimmer Biomet, J&J DePuy Synthes, Smith+Nephew, and Globus/NuVasive lead the segment. Procedure-volume tied to demographics; ASC migration is reshaping economics. ## Examples - A manufacturer designing an artificial hip joint must ensure its materials meet biocompatibility standards and that its design allows for long-term implantation. - A company developing a robotic-assisted surgical system for knee replacement needs to consider software validation, cybersecurity controls, and Usability Engineering per IEC 62366-1. - Before marketing a new spinal fusion device in Europe, a manufacturer must compile extensive clinical data to demonstrate safety and performance under the EU MDR. Common pitfalls - • One common pitfall is failing to adequately address biocompatibility requirements for implantable orthopedic devices, as outlined in ISO 10993 series standards. - • Another mistake is underestimating the complexity of clinical data requirements for high-risk orthopedic implants, especially under the EU MDR. - • Manufacturers sometimes overlook the specific post-market surveillance obligations for orthopedic devices, which include monitoring long-term performance and adverse events. ## Frequently asked questions What are the key regulatory considerations for orthopedic devices? Key considerations include device classification, [biocompatibility](/terms/biocompatibility), [sterilization](/terms/sterilization) validation, clinical evidence, and robust quality management systems compliant with standards like [ISO 13485](/terms/iso-13485):2016 and 21 CFR Part 820. How does cybersecurity apply to orthopedic devices? Are orthopedic devices subject to unique device identification (UDI) requirements? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Market Segments Surgical Robotics Robotic systems that assist surgeons in performing operations. ](/terms/surgical-robotics)[ Reimbursement ASC Site-of-Service Shift Migration of procedures from hospitals to ambulatory surgery centers. ](/terms/asc-shift) ### More in Market Segments · Same category [ Market Segments Aesthetic & Energy-Based Devices Lasers, RF, ultrasound, cryolipolysis, and IPL systems used for medical and cosmetic indications, body contouring, hair removal, skin tightening, vascular lesions. ](/terms/aesthetics-energy-devices)[ Market Segments AI Imaging Software Software that analyzes medical images to triage, detect, or quantify disease. ](/terms/ai-imaging)[ Market Segments Cardiac Rhythm Management(CRM) Implantable and external devices that monitor and treat cardiac arrhythmias, pacemakers, ICDs, CRT devices, and insertable cardiac monitors. ](/terms/cardiac-rhythm-management)[ Market Segments Cardiovascular Devices Devices for diagnosing, monitoring, or treating cardiovascular disease. ](/terms/cardiovascular) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Strategic Landscape](/ecosystems/strategic-landscape) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 AAOS· 1 AdvaMed· 1 MedTech Europe· 1 1. [1 AAOS Verified AAOS · aaos.org ](https://www.aaos.org/) 2. [2 AdvaMed - Industry Reports Verified AdvaMed · advamed.org ](https://www.advamed.org/our-work/) 3. [3 MedTech Europe - Facts & Figures Verified MedTech Europe · medtecheurope.org ](https://www.medtecheurope.org/datahub/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Building a connected device in this segment? Blue Goat Cyber specializes in MedTech cybersecurity across imaging, cardiac, IVD, surgical, and other connected segments. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Market Segments Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=orthopedics) Learn in 60 seconds Card Lesson Quiz Implants and instruments for bone, joint, and spine conditions. - · Stryker, Zimmer Biomet, J&J DePuy Synthes, Smith+Nephew, and Globus/NuVasive lead the segment. - · Procedure-volume tied to demographics; ASC migration is reshaping economics. - · Robotics-assisted surgery is an increasingly important sub-segment. Remember this Watch out: One common pitfall is failing to adequately address biocompatibility requirements for implantable orthopedic devices, as outlined in ISO 10993 series standards. Related terms - [Surgical Robotics ](/terms/surgical-robotics) - [ASC Site-of-Service Shift ](/terms/asc-shift) You may also need Auto-suggested from Market Segments and shared keywords. - [Spine ](/terms/spine) - [ENT Devices ](/terms/ent-devices) - [Ophthalmology Devices ](/terms/ophthalmology-devices) - [Patient Monitoring ](/terms/patient-monitoring) - [Clinical Laboratory Improvement Amendments(CLIA) ](/terms/clia) - [Dental Devices ](/terms/dental-devices) [All Market Segments terms](/terms?cat=Market%20Segments) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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