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Sign in to claim this brandDEPUY INTERNATIONAL LTD
US
Last updated May 24, 2026
What DEPUY INTERNATIONAL LTD makes
Depuy International Ltd manufactures reusable orthopaedic instruments and trial prostheses for hip and knee replacements, including femoral stem and acetabulum trials, broaches, and surgical positioning templates. Their product line also includes knee femur and tibia prosthesis trials, designed to assist in precise implant placement during surgical procedures.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Depuy International Ltd is based in 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 Depuy International Ltd manufacture?
Depuy International Ltd specializes in reusable orthopaedic instruments and trial prostheses primarily used in hip and knee replacement surgeries. Their devices include positioning instruments for prosthesis implantation, femoral stem and acetabulum trials, broaches, knee femur and tibia prosthesis trials, and surgical implant templates. These tools help surgeons achieve precise implant placement during procedures.
Where is Depuy International Ltd based?
Depuy International Ltd is based in the United States. The company’s headquarters and operations are located within the country, though it may have global distribution or subsidiary networks for its devices.
Which regulatory registries list Depuy International Ltd’s devices?
Depuy International Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the United States, ensuring transparency and traceability for healthcare providers and regulators.
How are Depuy International Ltd’s devices classified under FDA regulations?
Depuy International Ltd’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards or special controls due to moderate risk. The classification depends on factors like the device’s purpose, potential risks, and intended use in orthopaedic procedures.
What is the purpose of the trial prostheses manufactured by Depuy International Ltd?
The trial prostheses produced by Depuy International Ltd, such as femoral stem trials, acetabulum trials, and knee femur/tibia trials, are used during surgery to test fit, alignment, and sizing before permanent implants are placed. This step ensures the final prosthesis will be correctly positioned, improving surgical outcomes and reducing complications.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- xx.xx
- —
- —
- [email protected]
- Phone
- +1(800)255-2500
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 896498813
Catalogue (406)
Page 4 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Rpf Pathway | 9505-01-555 | FDA UDI | Class I | Active |
| Pathway | 9505-01-509 | FDA UDI | Class I | Active |
| Charnley | 9623-40-000 | FDA UDI | Class II | Unknown |
| Pathway | 9505-01-510 | FDA UDI | Class I | Active |
| Sigma | 2960-00-414 | FDA UDI | Class I | Active |
| Sigma Pathway | 9505-01-614 | FDA UDI | Class I | Active |
| C-Stem | 9611-81-500 | FDA UDI | Class I | Active |
| Charnley | 9630-32-000 | FDA UDI | Class I | Active |
| P.f.c. | 85-3841 | FDA UDI | Class II | Active |
| C-Stem | 9611-87-000 | FDA UDI | Class I | Active |
| Charnley | 9620-47-000 | FDA UDI | Class I | Active |
| Aml | 1554-08-000 | FDA UDI | Class II | Active |
| Sigma | 9505-01-427 | FDA UDI | Class I | Active |
| C-Stem | 9614-16-000 | FDA UDI | Class I | Active |
| Aml | 234-52-1000 | FDA UDI | Class I | Active |
| Sigma Pathway | 9505-01-114 | FDA UDI | Class I | Active |
| Sigma | 9505-01-285 | FDA UDI | Class I | Active |
| Elite | 9626-13-000 | FDA UDI | Class I | Active |
| P.f.c. | 85-7726 | FDA UDI | Class II | Active |
| C-Stem | 9612-18-500 | FDA UDI | Class II | Active |
| C-Stem | 9612-04-501 | FDA UDI | Class I | Active |
| S-Rom | 9005-98-210 | FDA UDI | Class I | Active |
| Sigma | 2960-00-408 | FDA UDI | Class I | Active |
| Charnley | 9623-47-000 | FDA UDI | Class II | Unknown |
| Lcs | 9505-01-055 | FDA UDI | Class I | Active |
| Sigma | 9505-01-188 | FDA UDI | Class I | Active |
| Sigma High Performance | 9505-01-416 | FDA UDI | Class I | Active |
| P.f.c. Sigma Rpf | 95-9003 | FDA UDI | Class I | Active |
| Duraloc | 2239-52-501 | FDA UDI | Class I | Active |
| Pathway | 1299-01-061 | FDA UDI | Class I | Active |
| C-Stem | 9611-93-500 | FDA UDI | Class I | Active |
| Sigma High Performance | 9505-01-412 | FDA UDI | Class I | Active |
| Lcs | 9505-01-181 | FDA UDI | Class I | Active |
| P.f.c. | 85-3842 | FDA UDI | Class II | Active |
| Elite | 2522-22-003 | FDA UDI | Class I | Active |
| C-Stem | 2580-00-016 | FDA UDI | Class I | Active |
| C-Stem | 9613-99-500 | FDA UDI | Class I | Active |
| Lcs Complete Pathway | 9505-01-069 | FDA UDI | Class I | Active |
| C-Stem | 2580-00-014 | FDA UDI | Class I | Active |
| Charnley | 9626-20-000 | FDA UDI | Class I | Active |
| Charnley | 9630-35-001 | FDA UDI | Class I | Active |
| C-Stem | 9612-10-500 | FDA UDI | Class II | Active |
| Charnley | 9620-45-000 | FDA UDI | Class I | Unknown |
| C-Stem | 9612-01-501 | FDA UDI | Class I | Active |
| C-Stem | 9614-11-000 | FDA UDI | Class I | Active |
| Charnley | 9622-48-000 | FDA UDI | Class I | Active |
| Sigma High Performance | 9505-01-410 | FDA UDI | Class I | Active |
| C-Stem | 258000046 | FDA UDI | Class I | Active |
| Charnley | 9623-49-000 | FDA UDI | Class II | Unknown |
| Lcs | 9505-01-118 | FDA UDI | Class I | Active |
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