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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 22 of 24| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Oxford Partial Knee System | 154725 | FDA UDI | Class III | Active |
| Exact Alliance Tapered Reamer | X31-400028 | FDA UDI | Class I | Active |
| Oxford Partial Knee System | 159584 | FDA UDI | Class III | Active |
| Oxford Partial Knee System | 154631 | FDA UDI | Class III | Active |
| Oxford® Knee System | 32-423200 | FDA UDI | Class I | Active |
| BIOLOX® delta Modular Ceramic Head | 650-0660 | FDA UDI | Class II | Active |
| Vanguard M Series Knee | 32-423103 | FDA UDI | Class I | Active |
| Recap Hip Instrumentation | 31-500752 | FDA UDI | Class I | Active |
| Exact Alliance Tapered Reamer | X31-400030 | FDA UDI | Class I | Active |
| Oxford Partial Knee System | 32-422709 | FDA UDI | Class III | Active |
| BIOLOX® Option | 650-1068 | FDA UDI | Class II | Active |
| Maxim Knee System | 32-345361 | FDA UDI | Class I | Active |
| Oxford Partial Knee System | 159795 | FDA UDI | Class III | Active |
| Femoral Elevator | 31-555513 | FDA UDI | Class I | Active |
| Oxford Unicompartmental Knee Phase 3spherical Cutter | 32-420331 | FDA UDI | Class I | Active |
| Oxford Partial Knee System | 32-421064 | FDA UDI | Class III | Active |
| Arcos® Revision Hip Instrumentation | 31-301921 | FDA UDI | Class II | Active |
| Oxford Partial Knee System | 32-422857 | FDA UDI | Class III | Active |
| Oxford Partial Knee System | 159575 | FDA UDI | Class III | Active |
| Oxford Partial Knee System | 159574 | FDA UDI | Class III | Active |
| Oxford Unicompartmental Knee Phase 3gap Gauge Size 6 & 7 | 32-420391 | FDA UDI | Class I | Active |
| Oxford Partial Knee System | 32-420377 | FDA UDI | Class III | Active |
| Maxim Knee System | 32-345383 | FDA UDI | Class I | Active |
| Oxford Partial Knee System | 32-422710 | FDA UDI | Class III | Active |
| Oxford Uni Knee System | 32-422817 | FDA UDI | Class I | Active |
| Maxim Knee System | 32-345312 | FDA UDI | Class I | Active |
| Ringloc Acetabular Provisional | 31-423725 | FDA UDI | Class I | Active |
| Agc Anatomic Femoral Provisional | 32-467340 | FDA UDI | Class I | Active |
| Oxford Partial Knee System | 32-420376 | FDA UDI | Class III | Active |
| Maxim Knee System | 32-345372 | FDA UDI | Class I | Active |
| Microplasty Mih Instrument | 31-555553 | FDA UDI | Class I | Active |
| BIOLOX® delta Modular Ceramic Head | 650-1160 | FDA UDI | Class II | Active |
| Oxford® Partial Knee System | 110031779 | FDA UDI | Class III | Active |
| Oxford® Partial Knee SystemOsteophyte Removal Tool | 32-422939 | FDA UDI | Class I | Active |
| Curved Acetabular Reamer | 31-555522 | FDA UDI | Class I | Active |
| Exact Alliance Tapered Reamer | X31-400033 | FDA UDI | Class I | Active |
| Microplasty Mih Instrument | 31-555555 | FDA UDI | Class I | Active |
| M2a 38mm Hip Instrumentation | 31-105054 | FDA UDI | Class I | Active |
| Oxford Partial Knee System | 159579 | FDA UDI | Class III | Active |
| Oxford Unicompartmental Knee Phase 3gap Gauge Size 6 & 7 | 32-421058 | FDA UDI | Class I | Active |
| Oxford Partial Knee System | 154648 | FDA UDI | Class III | Active |
| Stanmore Modular Hip | 31-410004 | FDA UDI | Class I | Active |
| Recap Hip Instrumentation | 31-500760 | FDA UDI | Class I | Active |
| Oxford Uni Knee System | 32-422834 | FDA UDI | Class I | Active |
| Vanguard Knee System | 32-423133 | FDA UDI | Class I | Active |
| Agc Tibial Punch | 32-467284 | FDA UDI | Class I | Active |
| Oxford Uni Knee SystemTibial Gap Gauge | 32-422794 | FDA UDI | Class I | Active |
| Oxford Partial Knee System | 159564 | FDA UDI | Class III | Active |
| Oxford Uni Knee System | 32-422980 | FDA UDI | Class I | Active |
| Oxford Unicompartmental Knee Phase 3gap Gauge Size 4 & 5 | 32-420390 | FDA UDI | Class I | 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