Cleared Traditional

K250646 - Impact PEEK Union Nail System

K250646 is an FDA 510(k) clearance for Impact PEEK Union Nail System, manufactured by Nvision Biomedical Technologies. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K250646 · Nvision Biomedical Technologies · Orthopedic device
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Jun 2025
Decision
99d
Days
Class 2
Risk

K250646 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 (San Antonio, US). The FDA issued a Cleared decision on June 11, 2025 after a review of 99 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K250646

510(k) Number K250646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2025
Decision Date June 11, 2025
Days to Decision 99 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
23d faster than avg
Panel avg: 122d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

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 107
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K250646.
Impact PEEK Union Nail System
K252657 · Nvision Biomedical Technologies, Inc. · Sep 2025
RONAVIS – FX (FX-001)
K250315 · AIRS, Inc. · Aug 2025
PediFlex™ Flexible Nail System
K251362 · OrthoPediatrics Corp. · 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
Hammerdesis™ Interphalangeal Fusion System
K231147 · Intelivation · Sep 2023