Cleared Special

K252657 - Impact PEEK Union Nail System (FDA 510(k) Clearance)

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

K252657 · Nvision Biomedical Technologies, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
28d
Days
Class 2
Risk

K252657 is an FDA 510(k) clearance for the Impact PEEK Union Nail System. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Nvision Biomedical Technologies, Inc. (San Antonio, US). The FDA issued a Cleared decision on September 19, 2025 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Nvision Biomedical Technologies, Inc. devices

Submission Details

510(k) Number K252657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2025
Decision Date September 19, 2025
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 HTY Pin, Fixation, Smooth
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 - HTY Pin, Fixation, Smooth

All 203
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K252657.
ZipToe™ Hammertoe Fusion System
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K250315 · AIRS, Inc. · Aug 2025
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K251362 · OrthoPediatrics Corp. · Jun 2025
Impact PEEK Union Nail System
K250646 · Nvision Biomedical Technologies · Jun 2025
Biomet Kirschner Wires (K-Wires)
K241014 · Biomet, Inc. · May 2024
OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail
K231272 · OSSIO , Ltd. · Dec 2023