Cleared Traditional

K153587 - Taps for Resorbable Screws

K153587 is an FDA 510(k) clearance for Taps for Resorbable Screws, manufactured by Synthes USA Products, LLC. The device is a Class 2 Neurology device with product code HBG cleared through the Traditional 510(k) pathway after a 399-day FDA review.

K153587 · Synthes USA Products, LLC · Neurology device
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Jan 2017
Decision
399d
Days
Class 2
Risk

K153587 is an FDA 510(k) clearance for the Taps for Resorbable Screws. Classified as Drills, Burrs, Trephines & Accessories (manual) (product code HBG), Class II - Special Controls.

Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on January 18, 2017 after a review of 399 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4300 - 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. Elevated predicate reliance profile. 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 Synthes USA Products, LLC devices

FDA 510(k) Submission Details - K153587

510(k) Number K153587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2015
Decision Date January 18, 2017
Days to Decision 399 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
251d slower than avg
Panel avg: 148d · This submission: 399d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBG Device Classification - Class 2, Special Controls

Product Code HBG Drills, Burrs, Trephines & Accessories (manual)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4300
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 - HBG Drills, Burrs, Trephines & Accessories (manual)

All 11
Devices cleared under the same product code (HBG) and FDA review panel - the closest regulatory comparables to K153587.
LEGACY
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MRII Cranial Drill and Accessories
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SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm
K151536 · Mri Interventions, Inc. · Jul 2015
MRII CRAINIAL DRILL
K122456 · Mri Interventions, Inc. · Mar 2013
FRAMELOCK
K022370 · Medtronic Xomed, Inc. · Oct 2002