K091453 is an FDA 510(k) clearance for the LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331. This device is classified as a Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (Class II - Special Controls, product code KRO).
Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 12, 2009, 86 days after receiving the submission on May 18, 2009.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3510.
| 510(k) Number | K091453 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2009 |
| Decision Date | August 12, 2009 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KRO - Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3510 |