Cleared Traditional

InCore® Lapidus System (K180257) - FDA 510(k) Clearance

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

K180257 · Nextremity Solutions, Inc. · Orthopedic device
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Apr 2018
Decision
85d
Days
Class 2
Risk

K180257 is an FDA 510(k) clearance for the InCore® Lapidus System. 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 April 25, 2018 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nextremity Solutions, Inc. devices

Submission Details

510(k) Number K180257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2018
Decision Date April 25, 2018
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 415
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K180257.
Fracture and Correction System
K180377 · In2bones USA, LLC · Jun 2018
VariAx 2 System
K180500 · Stryker GmbH · Jun 2018
Diamond Orthopedic Bone Fixation Screws and Pins
K180932 · Diamond Orthopedic, LLC · May 2018
SafetyFix EasyOut System
K180753 · Safetyfix Medical Technologies, Inc. · Apr 2018
MotoBAND CP Implant System
K173710 · Crossroads Extremity Systems, LLC · Feb 2018
G-Beam Fusion Beaming System
K172698 · Orthofix Srl · Feb 2018