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Sign in to claim this brandZimmer, Inc.
United States·US-MF-000001146
Last updated September 17, 2026
What Zimmer, Inc. makes
Zimmer, Inc. manufactures orthopaedic implants and surgical tools, including reusable positioning instruments for prosthesis implantation, tibial inserts, polyethylene acetabular liners, and trial components for knee and hip prostheses. Their portfolio also includes intramedullary nails for femur fixation, femoral stem trials, and sterilization/disinfection containers for surgical instruments. Prefabricated acetabulum prosthesis trials are part of their reusable trial device offerings.
The company’s devices are classified under FDA categories Class I, Class II, and Class III, with listings maintained in the FDA’s Unique Device Identifier (UDI) database. Their products are developed and distributed from the United States.
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 Zimmer, Inc. primarily manufacture?
Zimmer, Inc. specializes in orthopaedic devices, focusing on implants and surgical tools. Their portfolio includes reusable instruments like prosthesis implantation positioning tools, tibial inserts, and polyethylene acetabular liners. They also produce trial components for knee and hip prostheses, such as knee tibia and acetabulum prosthesis trials, as well as intramedullary nails for femur fixation. Additionally, they offer sterilization/disinfection containers for surgical instruments, ensuring reusable devices remain safe for repeated use.
Where is Zimmer, Inc. based, and where are its devices developed and distributed?
Zimmer, Inc. is based in the United States. The company develops and distributes its orthopaedic devices from this location, serving global markets with products designed for orthopaedic surgeries, including hip and knee replacements, as well as fracture fixation.
Which regulatory registries list Zimmer, Inc.’s devices?
Zimmer, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures transparency and traceability of medical devices, allowing healthcare providers and regulators to identify and track specific products by their unique identifiers.
How are Zimmer, Inc.’s orthopaedic devices classified under FDA regulations?
Zimmer, Inc.’s devices fall into three FDA classification 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 pre-market approval). The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with, such as implants for joint replacement or intramedullary nails for bone fixation.
What reasoning determines why Zimmer’s devices are classified under different FDA categories?
The FDA categorizes medical devices based on the level of risk they pose and the regulatory controls needed to ensure safety and performance. For example, reusable positioning instruments for prosthesis implantation are typically Class II due to their role in precise surgical procedures, requiring validation of their design and manufacturing processes. In contrast, intramedullary nails for femur fixation may be Class III because they are implanted within the body and carry higher risks, necessitating rigorous pre-market approval to confirm their safety and efficacy.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 1800, W Center Street, Warsaw, United States
- Website
- labeling.zimmerbiomet.com/
- —
- —
- [email protected]
- Phone
- +1 800 343 9500
- PRRC Contact
- Austin Allen
- EUDAMED SRN
- US-MF-000001146
- FDA FEI Number
- 1000220733
- DUNS Number
- 056038268
Catalogue (27800)
Page 39 of 500| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Psn P-Ref 4-In-1 Peg | SSI005336 | FDA UDI | Class II | Active |
| TMR+ Glenosphere Inserter 36 with Bottom | SSI007389 | FDA UDI | Class I | Active |
| Pelvic Screw Cannula | SSI007501 | FDA UDI | Class I | Active |
| Persona® The Personalized Knee® OsseoTi® | 42-5350-061-01 | FDA UDI | Class II | Active |
| Vanguard® Vivacit-E® | VE183446 | FDA UDI | Class II | Active |
| Mg Ii® | 5110-23-20 | FDA UDI | Class II | Active |
| Persona Total Knee System | 82-0153-168-07 | FDA UDI | Class II | Active |
| Trabecular Metal® | 00-4349-066-06 | FDA UDI | Class II | Active |
| Anatomical Shoulder™ | 01.04237.115 | FDA UDI | Class II | Active |
| Anatomical Shoulder™ Fracture | 01.04227.448 | FDA UDI | Class II | Active |
| Gender Solutions® Natural-Knee® | 00-5413-065-00 | FDA UDI | Class I | Active |
| Natural-Knee® | 6308-19-111 | FDA UDI | Class I | Active |
| NexGen® | 5997-77 | FDA UDI | Class I | Active |
| Persona® | 42-5399-018-14 | FDA UDI | Class I | Active |
| Natural-Knee® | 6265-06-105 | FDA UDI | Class I | Active |
| VerSys® | 7845-19-50 | FDA UDI | Class II | Active |
| Trabecular Metal® Acetabular Revision System | 00-7115-060-36 | FDA UDI | Class II | Active |
| Persona® | 42-5114-010-16 | FDA UDI | Class II | Active |
| NexGen LPS Flex | SSI004882 | FDA UDI | Class I | Active |
| Alloclassic® Zweymüller® SLO | 01.00121.070 | FDA UDI | Class II | Active |
| Dynesys® Top-Loading System | 01.03918.045 | FDA UDI | Class II | Active |
| Natural-Knee® | 6290-00-555 | FDA UDI | Class I | Active |
| Premier-Total™ | 9352-02-002 | FDA UDI | Class I | Unknown |
| Natural Nail® | 47-2495-240-11 | FDA UDI | Class II | Active |
| PERSONA® Vivacit-E® | 42-5121-010-16 | FDA UDI | Class II | Active |
| Natural-Knee® | 6720-25-100 | FDA UDI | Class II | Active |
| Persona™ | 42-5112-006-13 | FDA UDI | Class II | Active |
| VerSys® | 8018-36-02 | FDA UDI | Class II | Active |
| M/Dn® | 2254-300-08 | FDA UDI | Class II | Active |
| Persona® Knee System | 42-5766-054-01 | FDA UDI | Class II | Active |
| V-V Nail Tool | SSI002754 | FDA UDI | Class I | Active |
| Persona® | 42-5846-054-02 | FDA UDI | Class II | Active |
| G7® Freedom® Vivacit-E® | 30203203 | FDA UDI | Class II | Active |
| Persona® | 42-5892-002-30 | FDA UDI | Class II | Active |
| Persona™ | 42-5214-006-13 | FDA UDI | Class II | Active |
| NexGen® | 5990-33-23 | FDA UDI | Class II | Active |
| Pressure Sentinel® | 2218-17-05 | FDA UDI | Class I | Active |
| NexGen® Prolong® | 5952-31-14 | FDA UDI | Class II | Active |
| Zimmer Persona Knee System | SSI004267 | FDA UDI | Class II | Active |
| PERSONA® Natural Tibia® | 42-5320-079-01 | FDA UDI | Class II | Active |
| Nexel® | 00-8401-056-20 | FDA UDI | Class II | Active |
| Natural-Knee® | 6725-13-201 | FDA UDI | Class II | Active |
| Itst® | 2256-180-10 | FDA UDI | Class II | Active |
| Alliance® | SBGL6021 | FDA UDI | Class II | Active |
| Trilogy® | 6120-72-28 | FDA UDI | Class II | Active |
| Sidus® Stem-Free Shoulder | 01.04555.770 | FDA UDI | Class II | Active |
| Zimmer Persona Knee System | SSI004296 | FDA UDI | Class II | Active |
| Trabecular Metal® | 00-4501-041-00 | FDA UDI | Class II | Active |
| PERSONA™ Trabecular Metal™ | 42-5002-066-01 | FDA UDI | Class II | Active |
| NexGen® | 5987-28 | FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Zimmer Gmbh WINTERTHUR Zurich · CH FEI 3005233524