Cleared Special

FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit

K253867 · ZuriMED Technologies AG · Orthopedic
Jan 2026
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K253867 is an FDA 510(k) clearance for the FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit, a Mesh, Surgical, Non-absorbable, Orthopaedics, Reinforcement Of Tendon (Class II — Special Controls, product code OWX), submitted by ZuriMED Technologies AG (Zurich, CH). The FDA issued a Cleared decision on January 2, 2026, 30 days after receiving the submission on December 3, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K253867 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 2025
Decision Date January 02, 2026
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code OWX — Mesh, Surgical, Non-absorbable, Orthopaedics, Reinforcement Of Tendon
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists In Tendon Repair.