Cleared Traditional

Osteotomy Wedge System

K252254 · Sinaptic Surgical · Orthopedic

Oct 2025

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K252254 is an FDA 510(k) clearance for the Osteotomy Wedge System, 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 review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K252254 FDA.gov
FDA Decision	Cleared 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

Device Classification

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.