NOVATION CERAMIC ARTICULATION HIP SYSTEM (AHS)
FDA premarket approval P050039/S017 · decided 2016-04-26
Approval details
- PMA number
- P050039
- Supplement
- S017
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NOVATION CERAMIC ARTICULATION HIP SYSTEM (AHS)
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Exactech, Inc.
- Date received
- 2015-07-06
- Decision date
- 2016-04-26
- Days to decision
- 295 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Gainesville, FL
- Statement
- Approval for a manufacturing site located at Orchid Detroit 23149 Commerce Drive, Farmington Hills, Michigan, 48335.
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 |