Cleared Traditional

K162171 - S4 Screw System

K162171 is an FDA 510(k) clearance for S4 Screw System, manufactured by Subchondral Solutions. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 400-day FDA review.

K162171 · Subchondral Solutions · Orthopedic device
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Sep 2017
Decision
400d
Days
Class 2
Risk

K162171 is an FDA 510(k) clearance for the S4 Screw System™. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Subchondral Solutions (Los Gatos, US). The FDA issued a Cleared decision on September 7, 2017 after a review of 400 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Subchondral Solutions devices

FDA 510(k) Submission Details - K162171

510(k) Number K162171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2016
Decision Date September 07, 2017
Days to Decision 400 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
278d slower than avg
Panel avg: 122d · This submission: 400d
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 726
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K162171.
Large Screws Range
K172596 · Newclip Technics · Oct 2017
BePOD® Foot Screws
K163148 · Fournitures Hospitalieres Industrie · Sep 2017
BePOD® EZ Weil Screws
K163710 · Fournitures Hospitalieres Industrie · Sep 2017
Medline UNITE® Snap-Off Screws
K170782 · Medline Industries, Inc. · Aug 2017
Axis Charcot Fixation System, 4.5 to 8.5mm Screw System
K171018 · Extremity Medical, LLC · Jul 2017
Hammertoe Correction System
K171448 · Life Spine, Inc. · Jul 2017