Cleared Special

MotoCLIP/HiMAX Step Staple Implant System (K181866) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K181866 · Crossroads Extremity Systems, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
28d
Days
Class 2
Risk

K181866 is an FDA 510(k) clearance for the MotoCLIP/HiMAX Step Staple Implant System. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Crossroads Extremity Systems, LLC (Memphis, US). The FDA issued a Cleared decision on August 9, 2018 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Crossroads Extremity Systems, LLC devices

Submission Details

510(k) Number K181866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2018
Decision Date August 09, 2018
Days to Decision 28 days
Submission Type Special
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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JDR Staple, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 Consultant

Mrc-X, LLC
Theresa Leister

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JDR Staple, Fixation, Bone

All 65
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K181866.
Geo Staple System
K182212 · Gramercy Extremity Orthopedics, LLC · Jan 2019
DynaClipTM Bone Staple
K181781 · MedShape, Inc. · Nov 2018
DynaBridge
K181815 · Fusion Orthopedics, LLC · Oct 2018
DePuy Synthes Static Staples
K180544 · Synthes USA Products, LLC · Jul 2018
MotoCLIP/HiMAX Implant System
K181410 · Crossroads Extremity Systems, LLC · Jun 2018
Clench Compression Staple
K173775 · F & A Foundation, LLC D.B.A. Reign Medical · Apr 2018