Cleared Traditional

K162864 - OsteoVation Impact

K162864 is an FDA 510(k) clearance for OsteoVation Impact, manufactured by Skeletal Kinetics, LLC. The device is a Class 2 Neurology device with product code GXP cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K162864 · Skeletal Kinetics, LLC · Neurology device
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Jan 2017
Decision
92d
Days
Class 2
Risk

K162864 is an FDA 510(k) clearance for the OsteoVation Impact. Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by Skeletal Kinetics, LLC (Cupertino, US). The FDA issued a Cleared decision on January 13, 2017 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5300 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Skeletal Kinetics, LLC devices

FDA 510(k) Submission Details - K162864

510(k) Number K162864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2016
Decision Date January 13, 2017
Days to Decision 92 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 148d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXP Device Classification - Class 2, Special Controls

Product Code GXP Methyl Methacrylate For Cranioplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5300
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 Neurology devices follow this clearance model.

Regulatory Peers - GXP Methyl Methacrylate For Cranioplasty

All 27
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K162864.
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