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Sign in to claim this brandBiomet Uk Ltd
US
Last updated May 24, 2026
What Biomet Uk Ltd makes
Biomet UK Ltd manufactures unicondylar knee prostheses, trial components for knee and hip implants (including tibia, femur, and femoral head), reusable surgical instruments such as templates and probes, and orthopaedic tools like bone-reamers and implant inserters/extractors. Their portfolio also includes modular hip systems and gap gauges for knee alignment, designed for use in orthopaedic and ENT surgeries.
The company’s devices are classified under FDA categories Class I, II, and III, with listings in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates under US regulatory oversight, adhering to applicable medical device compliance standards.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Biomet UK Ltd manufacture?
Biomet UK Ltd specializes in orthopaedic and reusable surgical devices. Their portfolio includes unicondylar knee prostheses, trial components for knee and hip implants (such as tibia, femur, and femoral head trials), reusable surgical instruments like templates and probes, and orthopaedic tools such as bone-reamers and implant inserters/extractors. They also produce modular hip systems and knee alignment gauges, primarily for orthopaedic and ENT surgical procedures.
Where is Biomet UK Ltd based, and under which regulatory framework do they operate?
Biomet UK Ltd is based in the United States. Their devices fall under FDA regulatory oversight, meaning they must comply with U.S. medical device regulations, including classification under FDA categories such as Class I, II, or III. This framework ensures their products meet safety and performance standards before entering the market.
Which regulatory registries or databases list Biomet UK Ltd’s devices?
Biomet UK Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their distribution and use, ensuring transparency and traceability for regulatory and clinical purposes.
How are Biomet UK Ltd’s devices classified by the FDA?
Biomet UK Ltd’s devices are classified under three FDA categories: Class I (generally low-risk devices), Class II (devices requiring special controls to ensure safety and effectiveness), and Class III (high-risk devices requiring premarket approval). Classification depends on factors like intended use, risk level, and potential impact on patient safety, with stricter oversight for higher-risk devices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- zimmerbiomet.com
- —
- —
- [email protected]
- Phone
- +1(800)348-9500
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 219322575
Catalogue (1179)
Page 9 of 24| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Oxford Partial Knee System | 159794 | FDA UDI | Class III | Active |
| Recap Hip Instrumentation | 31-500950 | FDA UDI | Class I | Active |
| Recap/Magnum Hip Instrumentation | 31-158944 | FDA UDI | Class I | Active |
| M2a 38mm | 31-103614 | FDA UDI | Class I | Active |
| Oxford Uni Knee System | 32-422828 | FDA UDI | Class I | Active |
| Oxford Partial Knee System | 32-422697 | FDA UDI | Class III | Active |
| Mallory-Head Acetabular Shell | 11-104160 | FDA UDI | Class II | Active |
| M2a 38mm | 31-103714 | FDA UDI | Class I | Active |
| Oxford Unicompartmental Knee Phase 3posterior Cutting Block | 32-420328 | FDA UDI | Class I | Active |
| Agc Universal | 32-467706 | FDA UDI | Class I | Active |
| Agc Anatomic | 32-467611 | FDA UDI | Class I | Active |
| Maxim Knee System | 32-345364 | FDA UDI | Class I | Active |
| Bi-Metric Provisional | 31-473461 | FDA UDI | Class I | Active |
| Oxford Partial Knee System | 154615 | FDA UDI | Class III | Active |
| Hiploc System | 190101 | FDA UDI | Class II | Active |
| Modular Stem Extractor | 31-473589 | FDA UDI | Class I | Active |
| G7® Acetabular System | 110026853 | FDA UDI | Class II | Active |
| Mallory-Head Instrumentation | 104460 | FDA UDI | Class I | Active |
| Exact Alliance Tapered Reamer | X31-400036 | FDA UDI | Class I | Active |
| Oxford Microplasty Knee Systemfemoral Instrument Tray | 32-423537 | FDA UDI | Class I | Active |
| Stanmore Modular Hip System | 31-400144 | FDA UDI | Class I | Active |
| Recap Hip Instrumentation | 31-500248 | FDA UDI | Class I | Active |
| Agc Anatomic Femoral Provisional | 32-467344 | FDA UDI | Class I | Active |
| Magnum Instrumentation | 31-141085 | FDA UDI | Class I | Active |
| Instrument | 31-473601 | FDA UDI | Class I | Active |
| G7® Acetabular System | 110026855 | FDA UDI | Class II | Active |
| Taperloc Exact Instrumentation | 31-103215 | FDA UDI | Class I | Active |
| Oxford® Partial Knee System | 32-420660 | FDA UDI | Class I | Active |
| Modular Acetabular Grater Reamershell 70mm | 29-476070 | FDA UDI | Class I | Active |
| Stanmore Modular Hip System | 31-400142 | FDA UDI | Class I | Active |
| Oxford Microplasty Knee Systemtibial Instrument Tray | 32-423539 | FDA UDI | Class I | Active |
| Stanmore Modular Hip System | 31-400141 | FDA UDI | Class I | Active |
| Oxford Partial Knee System | 32-422723 | FDA UDI | Class III | Active |
| Oxford Partial Knee System | 32-420826 | FDA UDI | Class III | Active |
| Exact Alliance Tapered Reamer | X31-400035 | FDA UDI | Class I | Active |
| Oxford Partial Knee System | 154645 | FDA UDI | Class III | Active |
| Modular Head Removal Instrument | 31-473538 | FDA UDI | Class I | Active |
| Oxford Partial Knee System | 154636 | FDA UDI | Class III | Active |
| Recap Hip Instrumentation | 31-500746 | FDA UDI | Class I | Active |
| Recap/Magnum Instrumentation | 31-158966 | FDA UDI | Class I | Active |
| Biomet® Hip Instrumentation | 35-000099 | FDA UDI | Class I | Active |
| Microplasty Mih Instrument | 31-555552 | FDA UDI | Class I | Active |
| Agc Knee Instrumentation | 32-467707 | FDA UDI | Class I | Active |
| Freedom Ringloc-X Instrumentation | 31-117018 | FDA UDI | Class I | Active |
| Oxford® Unicompartmental Knee Phase 3tibial Resector | 32-420317 | FDA UDI | Class I | Active |
| Ringloc Acetabular Provisional | 31-423703 | FDA UDI | Class I | Active |
| Stanmore Modular Hip | 31-410000 | FDA UDI | Class I | Active |
| Maxim Knee Instrument | 32-348072 | FDA UDI | Class I | Active |
| Recap Hip Instrumentation | 31-500646 | FDA UDI | Class I | Active |
| Oxford Partial Knee System | 32-422711 | FDA UDI | Class III | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Biomet Uk Ltd. BRIDGEND · GB FEI 3002806535