FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇹 Austria
ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR
K Number: K121297
·
Decision Dec 28, 2012
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
44
Review Days
242
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR
- K Number
- K121297
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Signature Orthopaedics Pty, Ltd.
- Date Received
- April 30, 2012
- Decision Date
- December 28, 2012
- Product Code
- LPH
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LPH), ordered by most recent decision date.
iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating
FDA 510(k)
FDA Class 2
·Orthopedic
Taperloc® Complete Hip Stem
FDA 510(k)
FDA Class 2
·Orthopedic
G7® Revision Acetabular System
FDA 510(k)
FDA Class 2
·Orthopedic
Mpact 3D Metal Implants Extension DMLS Technology
FDA 510(k)
FDA Class 2
·Orthopedic
Velora Acetabular System
FDA 510(k)
FDA Class 2
·Orthopedic
TaperSet Hip System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Signature Orthopaedics Pty, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | Mar 12, 2026 | Substantially Equivalent |
| K253239 | Active-V Total Knee System; World Total Knee System | Dec 23, 2025 | Substantially Equivalent |
| K251771 | Cambridge Partial Knee | Dec 16, 2025 | Substantially Equivalent |
| K243021 | Longboard Revision Hip Stem | Aug 7, 2025 | Substantially Equivalent |
| K242674 | Freedom Posterior Cervical Screws | May 13, 2025 | Substantially Equivalent |
| K242477 | Shoulder Soft Tissue Anchors | May 12, 2025 | Substantially Equivalent |
| K243043 | Origin Cemented Hip Stem | May 2, 2025 | Substantially Equivalent |
| K243029 | Origin TT Stem | Mar 11, 2025 | Substantially Equivalent |
| K243162 | World Liner | Nov 25, 2024 | Substantially Equivalent |
| K240683 | Rx Knee System | Sep 11, 2024 | Substantially Equivalent |