Cleared Traditional

S4 Screw System (K191995) - FDA 510(k) Clearance

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

K191995 · Subchondral Solutions, Inc. · Orthopedic device
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Apr 2020
Decision
267d
Days
Class 2
Risk

K191995 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, Inc. (Los Gatos, US). The FDA issued a Cleared decision on April 18, 2020 after a review of 267 days - an extended review cycle.

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 Subchondral Solutions, Inc. devices

Submission Details

510(k) Number K191995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2019
Decision Date April 18, 2020
Days to Decision 267 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
145d slower than avg
Panel avg: 122d · This submission: 267d
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 417
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K191995.
InCore MPJ System
K200124 · Nextremity Solutions, Inc. · May 2020
Healix Compression Screw System
K200914 · Nvision Biomedical Technologies, Inc. · May 2020
Headless Compression Screw System
K200259 · Osteocentric Extremities, LLC · May 2020
T2 ICF
K193366 · Stryker GmbH · Mar 2020
restor3d Metallic Interference Screw
K193491 · Restor3d · Mar 2020
Omnia Medical Trauma Screws
K192096 · Omnia Medical, LLC · Feb 2020