NATURAL KNEE & NATURAL KNEE II
FDA premarket approval P940002/S003 · decided 2000-04-18
Approval details
- PMA number
- P940002
- Supplement
- S003
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NATURAL KNEE & NATURAL KNEE II
- Generic name
- PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
- Applicant
- Sulzermedica
- Date received
- 2000-03-24
- Decision date
- 2000-04-18
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- MBD
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Austin, TX
- Statement
- Approval for use of forged Ti alloy as a material for the construction of the stemmed tibial base plate component of the devices.
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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 |