Cleared Special

K170382 - Arthrex Compression Screws

K170382 is an FDA 510(k) clearance for Arthrex Compression Screws, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 93-day FDA review.

K170382 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
93d
Days
Class 2
Risk

K170382 is an FDA 510(k) clearance for the Arthrex Compression 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 May 11, 2017 after a review of 93 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. 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.

FDA 510(k) Submission Details - K170382

510(k) Number K170382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2017
Decision Date May 11, 2017
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
Pathway characteristics
Modification to existing cleared device.

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 1069
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K170382.
Flower Bone Screw Set
K170687 · Flower Orthopedics Corporation · Jun 2017
ALLY(TM) Bone Screws
K170698 · Providence Medical Technology, Inc. · May 2017
SMV Scientific Cannulated Screws
K170021 · Smv Scientific · May 2017
I.B.S. osteosynthesis screws
K170594 · In2bones Sas · May 2017
CAPTIVATE™ Compression Screws
K162825 · Globus Medical, Inc. · May 2017
HV Screw System
K170889 · Wrightmedicaltechnologyinc · Apr 2017
K170382 · Arthrex Compression Screws
Download PDF FDA Summary Arthrex, Inc.