Cleared Traditional

K193491 - restor3d Metallic Interference Screw

K193491 is an FDA 510(k) clearance for restor3d Metallic Interference Screw, manufactured by Restor3d. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K193491 · Restor3d · Orthopedic device
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Mar 2020
Decision
93d
Days
Class 2
Risk

K193491 is an FDA 510(k) clearance for the restor3d Metallic Interference Screw. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Restor3d (Durham, US). The FDA issued a Cleared decision on March 19, 2020 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. 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 Restor3d devices

FDA 510(k) Submission Details - K193491

510(k) Number K193491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2019
Decision Date March 19, 2020
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
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 680
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K193491.
Headless Compression Screw System
K200259 · Osteocentric Extremities, LLC · May 2020
S4 Screw System
K191995 · Subchondral Solutions, Inc. · Apr 2020
T2 ICF
K193366 · Stryker GmbH · Mar 2020
Omnia Medical Trauma Screws
K192096 · Omnia Medical, LLC · Feb 2020
Titanium Interference Screws
K193451 · Biomet, Inc. · Feb 2020
Arthrex Mini Comprehensive Fixation System - 1.0mm Screws
K193156 · Arthrex, Inc. · Feb 2020