K033489 is an FDA 510(k) clearance for the AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN. This device is classified as a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II - Special Controls, product code MBH).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 2, 2004, 211 days after receiving the submission on November 4, 2003.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3565.
| 510(k) Number | K033489 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 2003 |
| Decision Date | June 02, 2004 |
| Days to Decision | 211 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MBH — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3565 |