Cleared Special

K131683 - HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)

K131683 is an FDA 510(k) clearance for HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM), manufactured by Depuy Mitek, Inc., A Johnson and Johnson Company. The device is a Class 2 Orthopedic device with product code MBI cleared through the Special 510(k) pathway after a 17-day FDA review.

K131683 · Depuy Mitek, Inc., A Johnson and Johnson Company · Orthopedic device
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Jun 2013
Decision
17d
Days
Class 2
Risk

K131683 is an FDA 510(k) clearance for the HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM). 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, Inc., A Johnson and Johnson Company (Raynham, US). The FDA issued a Cleared decision on June 27, 2013 after a review of 17 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. 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 Depuy Mitek, Inc., A Johnson and Johnson Company devices

FDA 510(k) Submission Details - K131683

510(k) Number K131683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2013
Decision Date June 27, 2013
Days to Decision 17 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
105d faster than avg
Panel avg: 122d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

MBI Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 564
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K131683.
RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM
K130814 · Depuy Mitek, A Johnson & Johnson Company · Aug 2013
MULTIFIX S KNOTLESS FIXATION DEVICE
K131182 · Arthocare Corporation · Jul 2013
Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM
K131035 · Linvatec Corporation D/B/A Conmed Linvatec · Jul 2013
ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM
K130217 · OrthoPediatrics Corp. · Jun 2013
HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM)
K130539 · Depuy Mitek, A Johnson & Johnson Company · May 2013
KNOTLESS FIBERTAK SUTURE ANCHOR
K130458 · Arthrex, Inc. · May 2013