K231112 is an FDA 510(k) clearance for the Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner. This device is classified as a Shoulder Arthroplasty Implantation System (Class II - Special Controls, product code QHE).
Submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on September 12, 2023, 146 days after receiving the submission on April 19, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3660. Intended To Be Used To Assist In The Implantation Of A Specific Shoulder Arthroplasty Device Or A Set Of Specific Shoulder Arthroplasty Devices. Indicated To Include Guiding Alignment, Making Or Establishing Cuts, Selecting, Sizing, Attaching, Positioning Or Orienting Implant Components..
| 510(k) Number | K231112 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2023 |
| Decision Date | September 12, 2023 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | QHE — Shoulder Arthroplasty Implantation System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3660 |
| Definition | Intended To Be Used To Assist In The Implantation Of A Specific Shoulder Arthroplasty Device Or A Set Of Specific Shoulder Arthroplasty Devices. Indicated To Include Guiding Alignment, Making Or Establishing Cuts, Selecting, Sizing, Attaching, Positioning Or Orienting Implant Components. |