Identity
- Trade Name
- Klassic Blade Femoral Stem, Porous, Size 4 FDA UDI
- Generic Name
- Press-fit hip femur prosthesis, one-piece FDA UDI
- Model / Reference
- 3105.04.000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814703012235 FDA UDI
- 510(k) Number
- K151440 FDA UDI
- FDA Product Code
- LPH FDA UDILWJ FDA UDIMBL FDA UDI
- GMDN Term
- Press-fit hip femur prosthesis, one-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3360 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
Radiation Sterilization FDA UDI
Category: Press-fit hip femur prosthesis, one-piece
Klassic Blade Femoral Stem, Porous, Size 4 by Total Joint Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Press-fit hip femur prosthesis, one-piece.
- Masterloc Femoral Stems — Medacta International · Class II
- Paragon — GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED · Class II
- AMIStem H Femoral Stems — Medacta International · Class II
- Quadra H femoral stems — Medacta International · Class II
- Amis K Long femoral stems — Medacta International · Class II
- AMIStem-H Proximal Coating — Medacta International · Class II
- Trivicta — ORTHO DEVELOPMENT CORP. · Class II
- RECLAIMTM — DEPUY (IRELAND) · Class II
Cleared under the same submission
K151440 also covers:
- Klassic Blade Femoral Stem, Porous, Size 1 — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Blade Femoral Stem, Porous, Size 2 — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Blade Femoral Stem, Porous, Size 3 — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Blade Femoral Stem, Porous, Size 5 — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Blade Femoral Stem, Porous, Size 6 — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Blade Femoral Stem, Porous, Size 7 — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Blade Femoral Stem, Porous, Size 8 — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Blade Femoral Stem, Porous, Size 9 — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Blade Offset Femoral Stem, Porous, Size 1 — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Blade Offset Femoral Stem, Porous, Size 2 — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Blade Offset Femoral Stem, Porous, Size 3 — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Blade Offset Femoral Stem, Porous, Size 4 — TOTAL JOINT 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Total Joint Orthopedics, Inc.
Sources (1)
- FDA UDI 7af43863-7a28-4713-9a86-59bd23244ff9 36 fields · synced Jun 8, 2026