Cleared Traditional

K183628 - Arthrex TensionLoc System

K183628 is an FDA 510(k) clearance for Arthrex TensionLoc System, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K183628 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
90d
Days
Class 2
Risk

K183628 is an FDA 510(k) clearance for the Arthrex TensionLoc System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on March 26, 2019 after a review of 90 days - within the typical 510(k) review window.

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: 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

FDA 510(k) Submission Details - K183628

510(k) Number K183628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2018
Decision Date March 26, 2019
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 933
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K183628.
IntraLock Lapidus System
K182342 · Fusion Orthopedics, LLC · May 2019
Arthrex 2.5 mm Tenodesis Screw
K183395 · Arthrex, Inc. · Apr 2019
Monster® Screw System
K190586 · Paragon 28, Inc. · Apr 2019
OsteoCentric Bone Plate and Screw System
K190430 · Osteocentric Trauma · Mar 2019
Wright Jones Fracture System
K183026 · Wrightmedicaltechnologyinc · Mar 2019
ActivOrtho Nitinol Compression Screw System
K181610 · Activortho, Inc. · Mar 2019