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)
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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.

View all Arthrex, Inc. devices

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 930
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
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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