NOVATION CERAMIC ARTICULATION HIP SYSTEM
FDA premarket approval P050039/S021 · decided 2017-04-03
Approval details
- PMA number
- P050039
- Supplement
- S021
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- NOVATION CERAMIC ARTICULATION HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Exactech, Inc.
- Date received
- 2016-09-01
- Decision date
- 2017-04-03
- Days to decision
- 214 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Gainesville, FL
- Statement
- Approval to changes to the active surveillance study.
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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 |