The following data is part of a premarket notification filed by Conformis Inc. with the FDA for Itotal Identity Cruciate Retaining (cr) Knee Replacement System, Itotal Identity Posterior Stabilizing (ps) Knee Replacement System.
| Device ID | K210252 |
| 510k Number | K210252 |
| Device Name: | ITotal Identity Cruciate Retaining (CR) Knee Replacement System, ITotal Identity Posterior Stabilizing (PS) Knee Replacement System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Conformis Inc. 600 Technology Park Drive, 4th Floor Billerica, MA 01821 |
| Contact | Mary Kruitwagen |
| Correspondent | Mary Kruitwagen Conformis Inc. 600 Technology Park Drive, 4th Floor Billerica, MA 01821 |
| 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 | 2021-01-29 |
| Decision Date | 2021-02-17 |