Cleared Special

HEALIX ADVANCE Knotless anchors (K241010) - FDA 510(k) Clearance

Also marketed or referenced as:
HEALIX ADVANCE Self-Punching anchors

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K241010 · Depuy Mitek · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2024
Decision
152d
Days
Class 2
Risk

K241010 is an FDA 510(k) clearance for the HEALIX ADVANCE Knotless anchors. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Depuy Mitek (Raynham, US). The FDA issued a Cleared decision on September 11, 2024 after a review of 152 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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. Standard predicate reliance. 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 devices

Submission Details

510(k) Number K241010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2024
Decision Date September 11, 2024
Days to Decision 152 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
30d slower than avg
Panel avg: 122d · This submission: 152d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MAI Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - MAI Fastener, Fixation, Biodegradable, Soft Tissue

All 122
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K241010.
Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor
K250526 · Arthrex, Inc. · Mar 2025
GRYPHON™ X Anchor
K243790 · Depuy Mitek · Feb 2025
Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)
K243467 · Osteonic Co., Ltd. · Dec 2024
BIOCHARGE
K241912 · Nanofiber Solutions, LLC · Jul 2024
Arthrex AlloSync PushLock Suture Anchor
K233971 · Arthrex, Inc. · Jun 2024
SF Push- in Anchor
K240288 · Surgical Fusion Technologies GmbH · Apr 2024