Identity
- Trade Name
- Duracon FDA UDI
- Generic Name
- Metal-backed patella prosthesis FDA UDI
- Device Name
- Metal Backed Symmetric Patella FDA UDI
- Model / Reference
- 6642-2-145 FDA UDI
- Description
- Metal Backed Symmetric Patella FDA UDI
Identifiers
- Catalog Number
- 6642-2-145 FDA UDI
- Primary DI / UDI-DI
- 07613327048889 FDA UDI
- 510(k) Number
- K043374 FDA UDI
- FDA Product Code
- MBH FDA UDI
- GMDN Term
- Metal-backed patella prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Metal-backed patella prosthesis
Duracon by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metal-backed patella prosthesis.
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- Gender Solutions® Natural-Knee® — Zimmer, Inc. · Class II
- LCS COMPLETE — DEPUY (IRELAND) · Class III
- Persona® The Personalized Knee® OsseoTi® — Zimmer, Inc. · Class II
- LCS COMPLETE — DEPUY ORTHOPAEDICS, INC. · Class III
- LCS COMPLETE — DEPUY ORTHOPAEDICS, INC. · Class III
- NEXGEN® TRABECULAR METAL® — Zimmer, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Howmedica Osteonics Corp.
Sources (1)
- FDA UDI 10053a65-3a90-4e2c-9dbc-c3f07c52bcda 36 fields · synced Jun 1, 2026