Cleared Traditional

K151083 - BioBridge Collagen Matrix

K151083 is an FDA 510(k) clearance for BioBridge Collagen Matrix, manufactured by Fibralign Corporation. The device is a Class 2 Orthopedic device with product code OWY cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K151083 · Fibralign Corporation · Orthopedic device
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Jan 2016
Decision
261d
Days
Class 2
Risk

K151083 is an FDA 510(k) clearance for the BioBridge Collagen Matrix. Classified as Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon (product code OWY), Class II - Special Controls.

Submitted by Fibralign Corporation (Union City, US). The FDA issued a Cleared decision on January 8, 2016 after a review of 261 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.

View all Fibralign Corporation devices

FDA 510(k) Submission Details - K151083

510(k) Number K151083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2015
Decision Date January 08, 2016
Days to Decision 261 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
139d slower than avg
Panel avg: 122d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWY Device Classification - Class 2, Special Controls

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 11
Devices cleared under the same product code (OWY) and FDA review panel - the closest regulatory comparables to K151083.
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