Cleared Traditional

K170639 - HEALIX ADVANCE Anchor with PERMATAPE Su...

K170639 is the FDA 510(k) clearance for HEALIX ADVANCE Anchor with PERMATAPE Su... by Medos International SARL. It is a Class 2 Orthopedic device (product code MAI) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K170639 · Medos International SARL · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 2017
Decision
77d
Days
Class 2
Risk

K170639 is an FDA 510(k) clearance for the HEALIX ADVANCE Anchor with PERMATAPE Suture. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Medos International SARL (Le Locle, CH). The FDA issued a Cleared decision on May 18, 2017 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Medos International SARL devices

Submission Details

510(k) Number K170639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2017
Decision Date May 18, 2017
Days to Decision 77 days
Submission Type Traditional
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
45d faster than avg
Panel avg: 122d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Depuy Mitek, Inc., A Johnson and Johnson Company
Julie Vafides

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MAI Fastener, Fixation, Biodegradable, Soft Tissue

All 163
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K170639.
Arthrex PushLock
K173240 · Arthrex, Inc. · Jan 2018
HEALIX ADVANCE KNOTLESS Anchor
K171114 · Medos International SARL · Nov 2017
CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver
K171592 · Conmed Corporation · Aug 2017
Arthrex SwiveLock Anchors
K171141 · Arthrex, Inc. · May 2017
CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver
K170501 · Conmed Corporation · Mar 2017
INTRAFIX(TM) Advance Tibial Fastener System
K160804 · Medos International SARL · Jul 2016