Identity
- Trade Name
- 36mm Femoral Head, 12/14 Taper, +7mm Offset FDA UDI
- Generic Name
- Metallic femoral head prosthesis FDA UDI
- Model / Reference
- 3200.36.700 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814703010286 FDA UDI
- 510(k) Number
- K100445 FDA UDI
- FDA Product Code
- LWJ FDA UDIMBL FDA UDILPH FDA UDI
- GMDN Term
- Metallic femoral head prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3360 FDA UDI888.3358 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
Category: Metallic femoral head prosthesis
A comprehensive 2-3 paragraph SEO description written in clear, natural language. The Metallic femoral head prosthesis is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of total hip arthroplasty (THA), or articulate with the natural acetabulum directly or via a bipolar component as part of partial hip arthroplasty (hemiarthroplasty). The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.
Similar devices
Also classified as Metallic femoral head prosthesis.
- Normmed CoCr Femoral Head 28 +12 — NORMMED MEDİKAL SAN. VE TİC. A.Ş. · Class III
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- Orthinox — Howmedica Osteonics Corp. · Class II
- Orthinox — Howmedica Osteonics Corp. · Class II
- A110212031 — EUROS SAS · Class III
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- BIOMET HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- Femoral Head — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Cleared under the same submission
K100445 also covers:
- 32mm Femoral Head, 12/14 Taper, +0mm Offset — TOTAL JOINT ORTHOPEDICS, INC.
- 32mm Femoral Head, 12/14 Taper, +3.5mm Offset — TOTAL JOINT ORTHOPEDICS, INC.
- 32mm Femoral Head, 12/14 Taper, +7mm Offset — TOTAL JOINT ORTHOPEDICS, INC.
- 32mm Femoral Head, 12/14 Taper, -3.5mm Offset — TOTAL JOINT ORTHOPEDICS, INC.
- 36mm Femoral Head, 12/14 Taper, +0mm Offset — TOTAL JOINT ORTHOPEDICS, INC.
- 36mm Femoral Head, 12/14 Taper, +3.5mm Offset — TOTAL JOINT ORTHOPEDICS, INC.
- 36mm Femoral Head, 12/14 Taper, -3.5mm Offset — TOTAL JOINT ORTHOPEDICS, INC.
- Acetabular Insert with ApeX-Lnk Poly, 32mm Head, Size 48mm — TOTAL JOINT ORTHOPEDICS, INC.
- Acetabular Insert with ApeX-Lnk Poly, 32mm Head, Size 50mm — TOTAL JOINT ORTHOPEDICS, INC.
- Acetabular Insert with ApeX-Lnk Poly, 32mm Head, Size 52mm — TOTAL JOINT ORTHOPEDICS, INC.
- Acetabular Insert with ApeX-Lnk Poly, 32mm Head, Size 54mm — TOTAL JOINT ORTHOPEDICS, INC.
- Acetabular Insert with ApeX-Lnk Poly, 32mm Head, Size 56mm — TOTAL JOINT ORTHOPEDICS, INC.
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
- Total Joint Orthopedics, Inc.
Sources (1)
- FDA UDI bd2adbe9-3bca-44b1-ae09-3aee26e4df24 36 fields · synced Jun 22, 2026