Cleared Traditional

Arthrosurface Bone Screws (K172383) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172383 · Arthrosurface, Inc. · Orthopedic device
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Dec 2017
Decision
136d
Days
Class 2
Risk

K172383 is an FDA 510(k) clearance for the Arthrosurface Bone Screws. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on December 22, 2017 after a review of 136 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 Arthrosurface, Inc. devices

Submission Details

510(k) Number K172383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2017
Decision Date December 22, 2017
Days to Decision 136 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 122d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 418
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K172383.
MotoBAND CP Implant System
K173710 · Crossroads Extremity Systems, LLC · Feb 2018
G-Beam Fusion Beaming System
K172698 · Orthofix Srl · Feb 2018
HBS2 Headless Bone Screw
K171628 · Stuckenbrock Medizintechnik GmbH · Jan 2018
Cannulated Screw Internal Fixation System
K173286 · Life Spine, Inc. · Dec 2017
Medline UNITE® Snap-Off Screws
K170782 · Medline Industries, Inc. · Aug 2017
Hammertoe Correction System
K171448 · Life Spine, Inc. · Jul 2017