Cleared Traditional

K223342 - MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion System (FDA 510(k) Clearance)

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

K223342 · Crossroads Extremity Systems, LLC · Orthopedic device
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Mar 2023
Decision
149d
Days
Class 2
Risk

K223342 is an FDA 510(k) clearance for the MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, D.... 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 March 30, 2023 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Crossroads Extremity Systems, LLC devices

Submission Details

510(k) Number K223342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2022
Decision Date March 30, 2023
Days to Decision 149 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
27d slower than avg
Panel avg: 122d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1306
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K223342.
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K253718 · Nvision Biomedical Technologies, Inc. · Apr 2026