Question 1

What types of medical devices does Biomet UK Ltd manufacture?

Accepted Answer

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.

Question 2

Where is Biomet UK Ltd based, and under which regulatory framework do they operate?

Accepted Answer

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.

Question 3

Which regulatory registries or databases list Biomet UK Ltd’s devices?

Accepted Answer

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.

Question 4

How are Biomet UK Ltd’s devices classified by the FDA?

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Maxim Knee Instrument	32-348074	FDA UDI	Class I	Active
Magnum Instrumentation	31-141067	FDA UDI	Class I	Active
M2a 38mm Hip Instrumentation	31-105060	FDA UDI	Class I	Active
Oxford Uni Knee System	32-422988	FDA UDI	Class I	Active
Vanguard M Series Knee	32-423113	FDA UDI	Class I	Active
OXFORD UNICOMPARTMENTAL KNEE PHASE 3INTRAMEDULLARY ROD 300mm	32-420662	FDA UDI	Class I	Active
Recap Hip Instrumentation	31-500952	FDA UDI	Class I	Active
Magnum Instrumentation	31-141065	FDA UDI	Class I	Active
ASI 2.0 Instruments	110034707	FDA UDI	Class I	Active
Oxford Uni Knee System	32-422838	FDA UDI	Class I	Active
Bi-Metric Provisional	31-473459	FDA UDI	Class I	Active
Oxford Uni Knee System	32-422831	FDA UDI	Class I	Active
Exact Alliance Tapered Reamer	X31-400037	FDA UDI	Class I	Active
Agc Tibial Template	32-467280	FDA UDI	Class I	Active
Recap Hip Instrumentation	31-500246	FDA UDI	Class I	Active
Ringloc® Acetabular Provisional	31-423717	FDA UDI	Class I	Active
Oxford Uni Knee System	32-423230	FDA UDI	Class I	Active
Oxford Unicompartmental Knee Phase 3gap Gauge Size 2 & 3	32-420389	FDA UDI	Class I	Active
Recap Hip Instrumentation	31-500258	FDA UDI	Class I	Active
Recap Instrumentation	31-600367	FDA UDI	Class I	Active
Recap Hip Instrumentation	31-173756	FDA UDI	Class I	Active
Oxford Unicompartmental Knee Phase 3femoral Instrument Case	32-420724	FDA UDI	Class I	Active
Oxford Microplasty Knee System	32-423600	FDA UDI	Class I	Active
Stanmore Modular Hip	31-410001	FDA UDI	Class I	Active
Provisional Modular Head	31-473528	FDA UDI	Class I	Active
Modular Acetabular Grater Reamershell 68mm	29-476068	FDA UDI	Class I	Active
Oxford Fixed Lateral Bearing Partial Knee Replacement (bearings / Trays)	K133940	FDA 510(k)	Class II	Active
Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads	K192683	FDA 510(k)	Class II	Active
Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling	K200959	FDA 510(k)	Class II	Active

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