Identity
- Trade Name
- ACS® FDA UDI
- Generic Name
- Tibial insert FDA UDI
- Device Name
- FB+ PE-insert hyperflex FDA UDI
- Model / Reference
- 42452212 FDA UDI
- Description
- FB+ PE-insert hyperflex FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048844471132 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Tibial insert 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
Category: Tibial insert
Improve your knee replacement surgery experience with the ACS device, a cutting-edge implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis. This one-piece contoured polyethylene (PE) insert or more complex guide arm devices offer superior flexibility and movement, making it ideal for patients seeking optimal results.
Similar devices
Also classified as Tibial insert.
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- P.F.C. SIGMA — DEPUY (IRELAND) · Class II
- Truliant, Activit-E — Exactech, Inc. · Class II
- Maxim Knee System — Biomet Orthopedics, Inc. · Class II
- Scorpio — Howmedica Osteonics Corp. · Class II
- TriVerse Meniscal Insert PS+ — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- Scorpio — Howmedica Osteonics Corp. · Class II
- World Knee System — SIGNATURE ORTHOPAEDICS PTY LTD · 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 |
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Manufacturer
- Manufacturer
- implantcast GmbH
Sources (1)
- FDA UDI a78c0b35-c3c0-48e9-8a8c-be901612866f 34 fields · synced Oct 6, 2026