The following data is part of a premarket notification filed by Conformis, Inc. with the FDA for Itotal Posterior Stabilized (ps) Knee Replacement System, Itotal Cruciate Retaining (cr) Knee Replacement System.
| Device ID | K160025 |
| 510k Number | K160025 |
| Device Name: | ITotal Posterior Stabilized (PS) Knee Replacement System, ITotal Cruciate Retaining (CR) 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-06 |
| Decision Date | 2016-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850268007347 | K160025 | 000 |
| 00850268007170 | K160025 | 000 |
| 00850268007163 | K160025 | 000 |
| 00850268007156 | K160025 | 000 |
| 00850268007149 | K160025 | 000 |
| 00850268007132 | K160025 | 000 |
| 00850268007125 | K160025 | 000 |
| 00850268007118 | K160025 | 000 |
| 00850268007101 | K160025 | 000 |
| 00850268007095 | K160025 | 000 |
| 00850268007088 | K160025 | 000 |
| M572RPS1011113021 | K160025 | 000 |
| M572RPS1011112021 | K160025 | 000 |
| M572TPS1111111021 | K160025 | 000 |
| M572RPS0102000021 | K160025 | 000 |
| 00850268007187 | K160025 | 000 |
| 00850268007194 | K160025 | 000 |
| 00850268007330 | K160025 | 000 |
| 00850268007323 | K160025 | 000 |
| 00850268007316 | K160025 | 000 |
| 00850268007309 | K160025 | 000 |
| 00850268007293 | K160025 | 000 |
| 00850268007286 | K160025 | 000 |
| 00850268007279 | K160025 | 000 |
| 00850268007262 | K160025 | 000 |
| 00850268007255 | K160025 | 000 |
| 00850268007248 | K160025 | 000 |
| 00850268007231 | K160025 | 000 |
| 00850268007224 | K160025 | 000 |
| 00850268007217 | K160025 | 000 |
| 00850268007200 | K160025 | 000 |
| M572RPS0101700021 | K160025 | 000 |