The following data is part of a premarket notification filed by Conformis, Inc. with the FDA for Itotal Posterior Stabilized (ps) Knee Replacement System.
| Device ID | K140833 |
| 510k Number | K140833 |
| Device Name: | 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 | 2014-04-02 |
| Decision Date | 2014-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M572TPS1111111011 | K140833 | 000 |
| M572RPS0101500121 | K140833 | 000 |
| M572RPS0101500111 | K140833 | 000 |
| M572RPS0202200121 | K140833 | 000 |
| M572RPS0202100121 | K140833 | 000 |
| M572RPS0201000121 | K140833 | 000 |
| M572RPS0200800121 | K140833 | 000 |
| M572RPS0200700121 | K140833 | 000 |
| M572RPS0200600121 | K140833 | 000 |
| M572RPS0102200021 | K140833 | 000 |
| M572RPS0101800011 | K140833 | 000 |
| M572RPS0101600011 | K140833 | 000 |
| M572RPS0101900111 | K140833 | 000 |
| M572RPS0101900121 | K140833 | 000 |
| M572RPS0102000111 | K140833 | 000 |
| M572RPS0202000121 | K140833 | 000 |
| M572RPS0201900121 | K140833 | 000 |
| M572RPS0201800121 | K140833 | 000 |
| M572RPS0201700121 | K140833 | 000 |
| M572RPS0201600121 | K140833 | 000 |
| M572RPS0201500121 | K140833 | 000 |
| M572RPS0201400121 | K140833 | 000 |
| M572RPS0201300121 | K140833 | 000 |
| M572RPS0201200121 | K140833 | 000 |
| M572RPS0201100121 | K140833 | 000 |
| M572RPS0102000121 | K140833 | 000 |
| M572RPS0200900121 | K140833 | 000 |