Cleared Traditional

K133169 - MESO TENDON MATRIX (FDA 510(k) Clearance)

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

K133169 · Kensey Nash Corporation Dba Dsm Biomedical · Orthopedic device
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Dec 2013
Decision
64d
Days
Class 2
Risk

K133169 is an FDA 510(k) clearance for the MESO TENDON MATRIX. Classified as Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon (product code OWY), Class II - Special Controls.

Submitted by Kensey Nash Corporation Dba Dsm Biomedical (Exton, US). The FDA issued a Cleared decision on December 20, 2013 after a review of 64 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kensey Nash Corporation Dba Dsm Biomedical devices

Submission Details

510(k) Number K133169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date December 20, 2013
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWY Mesh, Surgical, Collagen, 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 Peers - OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

All 13
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