KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM
FDA premarket approval N980003 · decided 2003-11-26
Approval details
- PMA number
- N980003
- Trade name
- KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Djo Surgical
- Date received
- 1998-03-08
- Decision date
- 2003-11-26
- Days to decision
- 2089 days
- Decision code
- APWD
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Austin, TX
- Statement
- APPROVAL FOR THE PRODUCT DEVELOPMENT PROTOCOL (PDP) FOR THE KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM. THIS DEVICE IS INDICATED FOR USC IN PATIENTS REQUIRING PRIMARY TOTAL HIP ARTHROPLASTY FOR THE TREATMENT OF INFLAMMATORY TISSUE DISORDERS AND NONINFLAMMATORY DEGENERATIVE JOINT DISEASE, INCLUDING OSTEOARTHRITIS, POST-TRAUMATIC ARTHRITIS OR SECONDARY ARTHRITIS, AND AVASCULAR NECROSIS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| REVERSE SHOULDER PROSTHESIS (K092873) | Djo Surgical | 2009-10-27 |