K243768 is an FDA 510(k) clearance for the iTotal? Identity? Cruciate Retaining 3DP Porous Knee Replacement System. This device is classified as a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II - Special Controls, product code MBH).
Submitted by Restor3D, Inc. (Durham, US). The FDA issued a Cleared decision on March 27, 2025, 111 days after receiving the submission on December 6, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3565.
| 510(k) Number | K243768 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2024 |
| Decision Date | March 27, 2025 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MBH — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3565 |