The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew, Inc. Total Knee System Instrumentation.
| Device ID | K121393 |
| 510k Number | K121393 |
| Device Name: | SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Gino Rouss |
| Correspondent | Gino Rouss SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | MBH |
| Subsequent Product Code | HRY |
| Subsequent Product Code | HSX |
| Subsequent Product Code | JWH |
| Subsequent Product Code | KRO |
| Subsequent Product Code | KRQ |
| Subsequent Product Code | KRR |
| Subsequent Product Code | NPJ |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-09 |
| Decision Date | 2012-08-07 |
| Summary: | summary |