The following data is part of a premarket notification filed by Conformis, Inc. with the FDA for Itotal Cruciate Retaining (cr) Knee Replacement System, Itotal Posterior Stabilized (ps) Knee Replacement System.
| Device ID | K142161 |
| 510k Number | K142161 |
| Device Name: | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | CONFORMIS, INC. 28 Crosby Dr Bedford, MA 01730 |
| Contact | Amita Shah |
| Correspondent | Amita Shah CONFORMIS, INC. 28 Crosby Dr Bedford, MA 01730 |
| Product Code | JWH |
| Subsequent Product Code | OIY |
| Subsequent Product Code | OOG |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-06 |
| Decision Date | 2014-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M572RPS1011113011 | K142161 | 000 |
| M572RPS0101100011 | K142161 | 000 |
| M572PAT0113206011 | K142161 | 000 |
| M572PAT0113507011 | K142161 | 000 |
| M572PAT0113808011 | K142161 | 000 |
| M572PAT0114110011 | K142161 | 000 |
| M572PAT0212906011 | K142161 | 000 |
| M572PAT0213206011 | K142161 | 000 |
| M572PAT0213507011 | K142161 | 000 |
| M572PAT0213808011 | K142161 | 000 |
| M572PAT0214110011 | K142161 | 000 |
| M572PAT0112906011 | K142161 | 000 |
| M572RPS1011112011 | K142161 | 000 |
| M572RPS0101000011 | K142161 | 000 |