Cleared Special

K253867 - FiberLocker Implant (FDA 510(k) Clearance)

Also includes:
FiberLocker Instrument FiberLocker PowerUnit

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K253867 · ZuriMED Technologies AG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
30d
Days
Class 2
Risk

K253867 is an FDA 510(k) clearance for the FiberLocker Implant. Classified as Mesh, Surgical, Non-absorbable, Orthopaedics, Reinforcement Of Tendon (product code OWX), Class II - Special Controls.

Submitted by ZuriMED Technologies AG (Zurich, CH). The FDA issued a Cleared decision on January 2, 2026 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.3300 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all ZuriMED Technologies AG devices

Submission Details

510(k) Number K253867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OWX Mesh, Surgical, Non-absorbable, Orthopaedics, Reinforcement Of Tendon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists In Tendon Repair.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Kelliann Payne

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OWX Mesh, Surgical, Non-absorbable, Orthopaedics, Reinforcement Of Tendon

Devices cleared under the same product code (OWX) and FDA review panel - the closest regulatory comparables to K253867.
Integrity™ Implant
K250997 · Anika Therapeutics, Inc. · Jun 2025
SuturePatch Tissue Reinforcement
K243480 · Arthrex, Inc. · May 2025
FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)
K241219 · ZuriMED Technologies AG · Dec 2024
Integrity Implant
K223538 · Anika Therapeutics, Inc. · Aug 2023