Cleared Traditional

IntraLock Lapidus System (K182342) - FDA 510(k) Clearance

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

K182342 · Fusion Orthopedics, LLC · Orthopedic device
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May 2019
Decision
266d
Days
Class 2
Risk

K182342 is an FDA 510(k) clearance for the IntraLock Lapidus System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Fusion Orthopedics, LLC (Mesa, US). The FDA issued a Cleared decision on May 21, 2019 after a review of 266 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 Fusion Orthopedics, LLC devices

Submission Details

510(k) Number K182342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2018
Decision Date May 21, 2019
Days to Decision 266 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
144d slower than avg
Panel avg: 122d · This submission: 266d
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 K182342.
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
InCore® Lapidus Sterile Kits
K190231 · Nextremity Solutions, Inc. · May 2019
Arthrex 2.5 mm Tenodesis Screw
K183395 · Arthrex, Inc. · Apr 2019
Monster® Screw System
K190586 · Paragon 28, Inc. · Apr 2019
Arthrex TensionLoc System
K183628 · Arthrex, Inc. · Mar 2019