FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
Longboard Revision Hip Stem
K Number: K243021
·
Decision Aug 7, 2025
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
530
Applicant Total
44
Review Days
314
Basic Information
- Device Name
- Longboard Revision Hip Stem
- K Number
- K243021
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Signature Orthopaedics Pty, Ltd.
- Date Received
- September 27, 2024
- Decision Date
- August 7, 2025
- Product Code
- LZO
- 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 |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | FDA class 2 | Orthopedic |
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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 |
| 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 |
| K241690 | Logical Liner; World Liner; World Knee Patella | Aug 1, 2024 | Substantially Equivalent |