Cleared Traditional

K162542 - OsteoMed PINNACLE Driver

K162542 is an FDA 510(k) clearance for OsteoMed PINNACLE Driver, manufactured by Osteomed. The device is a Class 2 Neurology device with product code HBE cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K162542 · Osteomed · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
249d
Days
Class 2
Risk

K162542 is an FDA 510(k) clearance for the OsteoMed PINNACLE Driver. Classified as Drills, Burrs, Trephines & Accessories (simple, Powered) (product code HBE), Class II - Special Controls.

Submitted by Osteomed (Addison, US). The FDA issued a Cleared decision on May 19, 2017 after a review of 249 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4310 - 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 Osteomed devices

FDA 510(k) Submission Details - K162542

510(k) Number K162542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2016
Decision Date May 19, 2017
Days to Decision 249 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
101d slower than avg
Panel avg: 148d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBE Device Classification - Class 2, Special Controls

Product Code HBE Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4310
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 - HBE Drills, Burrs, Trephines & Accessories (simple, Powered)

All 42
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