Cleared Traditional

K173240 - Arthrex PushLock

K173240 is the FDA 510(k) clearance for Arthrex PushLock by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code MAI) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K173240 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
103d
Days
Class 2
Risk

K173240 is an FDA 510(k) clearance for the Arthrex PushLock. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on January 16, 2018 after a review of 103 days - within the typical 510(k) review window.

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: 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 Arthrex, Inc. devices

Submission Details

510(k) Number K173240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2017
Decision Date January 16, 2018
Days to Decision 103 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
19d faster than avg
Panel avg: 122d · This submission: 103d
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 Peers - MAI Fastener, Fixation, Biodegradable, Soft Tissue

All 162
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K173240.
HEALIX ADVANCE Anchor with DYNACORD Suture
K173859 · Medos International SARL · Apr 2018
Arthrex Corkscrew FT
K173788 · Arthrex, Inc. · Mar 2018
Fiji Anchor
K171228 · Sportwelding GmbH · 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
HEALIX ADVANCE Anchor with PERMATAPE Suture
K170639 · Medos International SARL · May 2017