This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for use of forged ti alloy as a material for the construction of the stemmed tibial base plate component of the devices.
| Device | NATURAL KNEE & NATURAL KNEE II |
| 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 | 2000-03-24 |
| Decision Date | 2000-04-18 |
| PMA | P940002 |
| Supplement | S003 |
| Product Code | MBD |
| Advisory Committee | Orthopedic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |