Cleared Traditional

Linkt Compression Staple System

K250712 · Trax Surgical · Orthopedic

May 2025

Decision

65d

Days

Class 2

Risk

About This 510(k) Submission

K250712 is an FDA 510(k) clearance for the Linkt Compression Staple System, a Staple, Fixation, Bone (Class II — Special Controls, product code JDR), submitted by Trax Surgical (Stoughton, US). The FDA issued a Cleared decision on May 14, 2025, 65 days after receiving the submission on March 10, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K250712 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 10, 2025
Decision Date	May 14, 2025
Days to Decision	65 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF