This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
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)
| Device | NATURAL-KNEE(R) AND NATURAL KNEE(R)II W/CSTI(TM) |
| Classification Name | Prosthesis, Knee, Patello/femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| 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 |
| Notice Date | 1997-06-30 |
| PMA | P940002 |
| Supplement | S |
| Product Code | MBD |
| Docket Number | 97M-0252 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SULZERMEDICA 9900 Spectrum Dr. austin,, TX 78717 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P940002 | Original Filing | |
| S005 | 2001-07-12 | Special (immediate Track) |
| S004 | ||
| S003 | 2000-03-24 | Special (immediate Track) |
| S002 | 1997-06-17 | Normal 180 Day Track |
| S001 | 1997-04-02 | Real-time Process |