K241097 is an FDA 510(k) clearance for the Arthrex Virtual Implant Positioning (VIP) System Software. This device is classified as a Shoulder Arthroplasty Implantation System (Class II - Special Controls, product code QHE).
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on October 2, 2024, 163 days after receiving the submission on April 22, 2024.
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 | K241097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2024 |
| Decision Date | October 02, 2024 |
| Days to Decision | 163 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. |