EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
FDA premarket approval P050039/S010 · decided 2012-08-24
Approval details
- PMA number
- P050039
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Exactech, Inc.
- Date received
- 2012-07-24
- Decision date
- 2012-08-24
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Gainesville, FL
- Statement
- CHANGES TO THE PROCESS FOR USE OF THE BURST TEST FIXTURE, WHICH IS USED TO EVALUATE THE SEAL STRENGTH OF THE PACKAGING.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Equinoxe® Shoulder System (K260583) | Exactech, Inc. | 2026-04-14 |
| Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants (K250713) | Exactech, Inc. | 2025-12-01 |
| Equinoxe® Shoulder System (K243448) | Exactech, Inc. | 2025-08-01 |
| Equinoxe® Scapula Fracture System (K243275) | Exactech, Inc. | 2025-06-26 |
| Alteon® HA Femoral Stems (K243839) | Exactech, Inc. | 2025-03-10 |
| Exactech® TRULIANT® Knee System (K240393) | Exactech, Inc. | 2024-10-03 |
| Equinoxe® Central Screw Baseplate System (K233482) | Exactech, Inc. | 2024-07-18 |
| Exactech® Vantage® Total Ankle System (K230717) | Exactech, Inc. | 2023-10-12 |