Cleared Traditional

K241219 - FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241219 · ZuriMED Technologies AG · Orthopedic device
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Dec 2024
Decision
224d
Days
Class 2
Risk

K241219 is an FDA 510(k) clearance for the FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrum.... 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 December 11, 2024 after a review of 224 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.3300 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K241219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2024
Decision Date December 11, 2024
Days to Decision 224 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 122d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.