K252254 is an FDA 510(k) clearance for the Osteotomy Wedge System. This device is classified as a Bone Wedge (Class II - Special Controls, product code PLF).
Submitted by Sinaptic Surgical (Slat Lake City, US). The FDA issued a Cleared decision on October 17, 2025, 88 days after receiving the submission on July 21, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030. Intended To Be Used With Ancillary Fixation For Opening Wedge Osteotomies Or Fusion In The Ankle, Foot, Proximal Tibia..
| 510(k) Number | K252254 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 2025 |
| Decision Date | October 17, 2025 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PLF - Bone Wedge |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |
| Definition | Intended To Be Used With Ancillary Fixation For Opening Wedge Osteotomies Or Fusion In The Ankle, Foot, Proximal Tibia. |