Cleared Traditional

K182361 - Arthrex Compression FT Screws

K182361 is an FDA 510(k) clearance for Arthrex Compression FT Screws, 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 110-day FDA review.

K182361 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2018
Decision
110d
Days
Class 2
Risk

K182361 is an FDA 510(k) clearance for the Arthrex Compression FT Screws. 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 December 18, 2018 after a review of 110 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 - K182361

510(k) Number K182361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2018
Decision Date December 18, 2018
Days to Decision 110 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
12d faster than avg
Panel avg: 122d · This submission: 110d
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 930
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K182361.
Biomet Headless Compression and Twist-Off Screws
K190035 · Biomet, Inc. · Feb 2019
EZStart Interference Screw
K182955 · Conmed Corporation · Jan 2019
PROSTEP MICA Screw System
K181377 · Wrightmedicaltechnologyinc · Jan 2019
AURORA™ Screw System
K182989 · MiRus, LLC · Dec 2018
ICONN Campbell Interference Screw
K180670 · Iconn Orthopedics, LLC · Dec 2018
Healix™ Compression Screw System
K182949 · Nvision Biomedical Technologies, LLC · Dec 2018