Identity
- Trade Name
- Vanguard® Knee System FDA UDI
- Generic Name
- Posterior-stabilized total knee prosthesis FDA UDI
- Model / Reference
- 183928 FDA UDI
Identifiers
- Catalog Number
- 183928 FDA UDI
- Primary DI / UDI-DI
- 00880304440326 FDA UDI
- FDA Product Code
- JWH FDA UDIHRY FDA UDIOIY FDA UDIMBH FDA UDIMBV FDA UDI
- GMDN Term
- Posterior-stabilized total knee prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI888.3530 FDA UDI888.3565 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Posterior-stabilized total knee prosthesis
Vanguard® Knee System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Posterior-stabilized total knee prosthesis.
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- Evolution — MicroPort Orthopedics Inc. · Class II
- Evolution — MicroPort Orthopedics Inc. · Class II
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- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
Cleared under the same submission
K042757 also covers:
- Vanguard SSK Knee System — Biomet Orthopedics, Inc.
- Vanguard SSK Knee System — Biomet Orthopedics, Inc.
- Vanguard SSK Knee System — Biomet Orthopedics, Inc.
- Vanguard SSK Knee System — Biomet Orthopedics, Inc.
- Vanguard SSK Knee System — Biomet Orthopedics, Inc.
- Vanguard SSK Knee System — Biomet Orthopedics, Inc.
- Vanguard SSK Knee System — Biomet Orthopedics, Inc.
- Vanguard SSK Knee System — Biomet Orthopedics, Inc.
- Vanguard SSK Knee System — Biomet Orthopedics, Inc.
- Vanguard® Knee System — Biomet Orthopedics, Inc.
- Vanguard® Knee System — Biomet Orthopedics, Inc.
- Vanguard® Knee System — Biomet Orthopedics, Inc.
K171054 also covers:
- AGC Tradition Knee System — Biomet Orthopedics, Inc.
- ASCENT KNEE SYSTEM — Biomet Orthopedics, Inc.
- Ascent Knee System — Biomet Orthopedics, Inc.
- Ascent Knee System — Biomet Orthopedics, Inc.
- BIOMET KNEE SYSTEM — Biomet Orthopedics, Inc.
- BIOMET KNEE SYSTEM — Biomet Orthopedics, Inc.
- Biomet Knee System — Biomet Orthopedics, Inc.
- Biomet Knee System — Biomet Orthopedics, Inc.
- Biomet Knee System — Biomet Orthopedics, Inc.
- Biomet® Knee System — Biomet Orthopedics, Inc.
- Biomet® Knee System — Biomet Orthopedics, Inc.
- Biomet® Knee System — Biomet Orthopedics, 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
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 3238dc91-471f-4743-b0a4-f4fccdaabb66 36 fields · synced May 30, 2026