Identity
- Trade Name
- GENESIS II FDA UDI
- Generic Name
- Patella prosthesis trial FDA UDI
- Device Name
- GENII OVAL RESURFACING PATELLA TRIAL 41MM FDA UDI
- Model / Reference
- 71930199 FDA UDI
- Description
- GENII OVAL RESURFACING PATELLA TRIAL 41MM FDA UDI
Identifiers
- Catalog Number
- 71930199 FDA UDI
- Primary DI / UDI-DI
- 00885556050385 FDA UDI
- 510(k) Number
- K951987 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Patella prosthesis trial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Moist Heat or Steam Sterilization FDA UDI
Category: Patella prosthesis trial
Genesis Ii by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Patella prosthesis trial.
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- Biomet® Series A™ — Biomet Orthopedics, Inc. · Class II
- Sombrero Patella Trial — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- Biomet® Series A™ — Biomet Orthopedics, Inc. · Class II
- Gender Solutions® Natural-Knee® — Zimmer, Inc. · Class I
- LCS — DEPUY ORTHOPAEDICS, INC. · Class I
Cleared under the same submission
K951987 also covers:
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
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 |
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Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 3539217a-255f-4ef6-95ad-ba964ecfe271 36 fields · synced Jun 8, 2026