Cleared Traditional

K130539 - HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM) (FDA 510(k) Clearance)

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

K130539 · Depuy Mitek, A Johnson & Johnson Company · Orthopedic device

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May 2013

Decision

81d

Days

Class 2

Risk

K130539 is an FDA 510(k) clearance for the HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM). Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Depuy Mitek, A Johnson & Johnson Company (Raynham, US). The FDA issued a Cleared decision on May 21, 2013 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Depuy Mitek, A Johnson & Johnson Company devices

Submission Details

510(k) Number	K130539 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 01, 2013
Decision Date	May 21, 2013
Days to Decision	81 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

41d faster than avg

Panel avg: 122d · This submission: 81d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 888.3040

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.