Cleared Special

Pre-Sutured Tendon

K253145 · Rti Surgical, Inc. · Orthopedic
Oct 2025
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K253145 is an FDA 510(k) clearance for the Pre-Sutured Tendon, a Suture, Nonabsorbable, Synthetic, Polyethylene (Class II — Special Controls, product code GAT), submitted by Rti Surgical, Inc. (Alachua, US). The FDA issued a Cleared decision on October 22, 2025, 27 days after receiving the submission on September 25, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.5000.

Submission Details

510(k) Number K253145 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2025
Decision Date October 22, 2025
Days to Decision 27 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code GAT — Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.5000

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