Cleared Traditional

InCore® Lapidus Sterile Kits (K190231) - FDA 510(k) Clearance

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

K190231 · Nextremity Solutions, Inc. · Orthopedic device
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May 2019
Decision
107d
Days
Class 2
Risk

K190231 is an FDA 510(k) clearance for the InCore® Lapidus Sterile Kits. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Nextremity Solutions, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 24, 2019 after a review of 107 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 Nextremity Solutions, Inc. devices

Submission Details

510(k) Number K190231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2019
Decision Date May 24, 2019
Days to Decision 107 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
15d faster than avg
Panel avg: 122d · This submission: 107d
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 414
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K190231.
OrthoPediatrics Cannulated Screw System
K190324 · OrthoPediatrics Corp. · Jul 2019
Treace Medical Concepts (TMC) Snap-Off Screw System
K183363 · Treace Medical Concepts, Inc. · Jun 2019
Mini Cannulated Headed and Headless Screw Set
K183104 · Stryker GmbH · Jun 2019
IntraLock Lapidus System
K182342 · Fusion Orthopedics, LLC · May 2019
Arthrex 2.5 mm Tenodesis Screw
K183395 · Arthrex, Inc. · Apr 2019
Monster® Screw System
K190586 · Paragon 28, Inc. · Apr 2019