Identity
- Trade Name
- Balance Knee Revision System FDA UDI
- Generic Name
- Knee arthroplasty wedge FDA UDI
- Device Name
- Size 6 Femoral Augment Distal 12mm FDA UDI
- Model / Reference
- 568-1612 FDA UDI
- Description
- Size 6 Femoral Augment Distal 12mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822409005451 FDA UDI
- 510(k) Number
- K060569 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Knee arthroplasty wedge 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
Yes
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Height — 12 Millimeter FDA UDI
Category: Knee arthroplasty wedge
The Balance Knee Revision System is a cutting-edge, implantable device designed to augment the implantation of knee femur or tibia prostheses. Made from high-quality metal materials such as cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), or titanium (Ti), this device serves as a space-filler adjacent to the prosthesis, increasing bone contact area and aiding stability.
Similar devices
Also classified as Knee arthroplasty wedge.
- NexGen® — Zimmer, Inc. · Class II
- ADVANCE® — MicroPort Orthopedics Inc. · Class II
- 3DMetal Diaphyseal Femoral Cones — Medacta International · Class II
- LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG · Class II
- LEGION — Smith & Nephew, Inc. · Class II
- ADVANTIM® — MicroPort Orthopedics Inc. · Class II
- LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KG · Class II
- Unity Total Knee System — CORIN LTD · Class II
Cleared under the same submission
K060569 also covers:
- Balance Knee Revision System — ORTHO DEVELOPMENT CORP.
- Balance Knee Revision System — ORTHO DEVELOPMENT CORP.
- Balance Knee Revision System — ORTHO DEVELOPMENT CORP.
- Balance Knee Revision System — ORTHO DEVELOPMENT CORP.
- Balance Knee Revision System — ORTHO DEVELOPMENT CORP.
- Balance Knee Revision System — ORTHO DEVELOPMENT CORP.
- Balance Knee Revision System — ORTHO DEVELOPMENT CORP.
- Balance Knee Revision System — ORTHO DEVELOPMENT CORP.
- Balance Knee Revision System — ORTHO DEVELOPMENT CORP.
- Balance Knee Revision System — ORTHO DEVELOPMENT CORP.
- Balance Knee Revision System — ORTHO DEVELOPMENT CORP.
- Balance Knee Revision System — ORTHO DEVELOPMENT CORP.
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Ortho Development Corp.
Sources (1)
- FDA UDI dbd45f68-fb17-420e-95b8-12c3b331924d 36 fields · synced Jul 6, 2026