Cleared Special

MIS Bunion Plating System (K190658) - FDA 510(k) Clearance

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

K190658 · Crossroads Extremity Systems, LLC · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 2019
Decision
29d
Days
Class 2
Risk

K190658 is an FDA 510(k) clearance for the MIS Bunion Plating System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Crossroads Extremity Systems, LLC (Memphis, US). The FDA issued a Cleared decision on April 12, 2019 after a review of 29 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 K190658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2019
Decision Date April 12, 2019
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HRS Plate, 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 - HRS Plate, Fixation, Bone

All 700
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K190658.
MatrixRIB Fixation System
K190409 · DePuy Synthes · May 2019
ATLAS Plating System
K190415 · MiRus, LLC · Apr 2019
Baby Gorilla/Gorilla Plating System
K190365 · Paragon 28, Inc. · Apr 2019
EVOS Small Fragment Upper Extremity Plates Line Additions
K190253 · Smith & Nephew, Inc. · Mar 2019
Stryker SternalPlate System
K183172 · Stryker · Mar 2019
MLP Special Locking Bone Plate System
K181843 · Maxxion Medical, LLC / Baumer SA · Mar 2019