Identity
- Trade Name
- Balance Knee Revision System FDA UDI
- Generic Name
- Knee femur stem prosthesis FDA UDI
- Device Name
- Dia.11x110mm Stem Extension Fluted FDA UDI
- Model / Reference
- 566-1111 FDA UDI
- Description
- Dia.11x110mm Stem Extension Fluted FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822409003358 FDA UDI
- 510(k) Number
- K031201 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Knee femur stem prosthesis 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
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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 110 Millimeter FDA UDIOuter Diameter — 11 Millimeter FDA UDI
Category: Knee femur stem prosthesis
Balance Knee Revision System by Ortho Development Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Knee femur stem prosthesis.
- Endo-Model Standard Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG · Class II
- Biomet Knee System — Biomet Orthopedics, Inc. · Class II
- Unity Total Knee System — CORIN LTD · Class II
- LINK Endo-Model EVO — WALDEMAR LINK GmbH & Co. KG · Class II
- OPTILOCK PERIARTICULAR PLATING SYSTEM — Biomet Orthopedics, Inc. · Class II
- Evolution Revision CCK System — MicroPort Orthopedics Inc. · Class II
- Modular Stem, — WALDEMAR LINK GmbH & Co. KG · Class II
- LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG · Class II
Cleared under the same submission
K031201 also covers:
- BKS Revision — ORTHO DEVELOPMENT CORP.
- BKS Revision — 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
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
- Ortho Development Corp.
Sources (1)
- FDA UDI b108e538-f9b9-4c3d-8223-f8c792eb8bb2 36 fields · synced May 30, 2026