Cleared Special

K193452 - MotoBAND CP Implant System

K193452 is the FDA 510(k) clearance for MotoBAND CP Implant System by Crossroads Extemity Systems, LLC. It is a Class 2 Orthopedic device (product code HRS) cleared through the Special 510(k) pathway after a 28-day FDA review.

K193452 · Crossroads Extemity Systems, LLC · Orthopedic device
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Jan 2020
Decision
28d
Days
Class 2
Risk

K193452 is an FDA 510(k) clearance for the MotoBAND CP Implant 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 Extemity Systems, LLC (Memphis, US). The FDA issued a Cleared decision on January 10, 2020 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 Extemity Systems, LLC devices

Submission Details

510(k) Number K193452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2019
Decision Date January 10, 2020
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 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 Peers - HRS Plate, Fixation, Bone

All 885
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