Cleared Special

K213530 - Nextra CH Cannulated Hammertoe System

K213530 is an FDA 510(k) clearance for Nextra CH Cannulated Hammertoe System, manufactured by Nextremity Solutions, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 34-day FDA review.

K213530 · Nextremity Solutions, Inc. · Orthopedic device
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Dec 2021
Decision
34d
Days
Class 2
Risk

K213530 is an FDA 510(k) clearance for the Nextra CH Cannulated Hammertoe System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Nextremity Solutions, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 9, 2021 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Nextremity Solutions, Inc. devices

FDA 510(k) Submission Details - K213530

510(k) Number K213530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2021
Decision Date December 09, 2021
Days to Decision 34 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
88d faster than avg
Panel avg: 122d · This submission: 34d
Pathway characteristics
Modification to existing cleared device.

HWC Device Classification - Class 2, Special Controls

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 680
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