NATURAL-KNEE(R) AND NATURAL KNEE(R)II W/CSTI(TM)
FDA premarket approval P940002 · decided 1997-03-21
Approval details
- PMA number
- P940002
- Trade name
- NATURAL-KNEE(R) AND NATURAL KNEE(R)II W/CSTI(TM)
- Generic name
- PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
- Applicant
- Sulzermedica
- Date received
- 1994-01-14
- Decision date
- 1997-03-21
- Days to decision
- 1162 days
- Decision code
- APRL
- Product code
- MBD
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Austin, TX
- Statement
- APPROVAL FOR THE NATURAL-KNEE(R) AND NATURAL KNEE(R) II WITH CSTI(TM). THESE DEVICES ARE INDICATED FOR UNCEMENTED USE IN SKELETALLY MATURE INDIVIDUALS WITH INTACT MEDIAL AND LATERAL COLLATERAL LIGAMENTS UNDERGOING PRIMARY SURGERY FOR REHABILITATING KNEES DAMAGED AS A RESULT FO NONINFLAMMATORY DEGENERATIVE JOINT DISEASE (NIDJD) OR INFLAMMATORY JOINT DISEASE (IJD)
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA (K002324) | Sulzermedica | 2000-08-24 |
| SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS (K993667) | Sulzermedica | 2000-01-28 |
| SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS (K990503) | Sulzermedica | 1999-12-09 |
| APR METASUL ACETABULAR INSERT (K993569) | Sulzermedica | 1999-12-01 |
| SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS (K992832) | Sulzermedica | 1999-11-19 |