Cleared Traditional

IntelliSense Drill (K143191) - FDA 510(k) Clearance

Class I Orthopedic device.

K143191 · Mcginley Innovations · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
106d
Days
Class 1
Risk

K143191 is an FDA 510(k) clearance for the IntelliSense Drill. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Mcginley Innovations (Casper, US). The FDA issued a Cleared decision on February 20, 2015 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - 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 Mcginley Innovations devices

Submission Details

510(k) Number K143191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2014
Decision Date February 20, 2015
Days to Decision 106 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment

All 14
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K143191.
SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM
K043310 · Synthes (Usa) · Jan 2005
AESCULAP HILAN MOTOR SYSTEM
K973736 · Aesculap, Inc. · Dec 1997
SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)
K971544 · Synthes (Usa) · May 1997
SYNTHES STERILE DRILL BITS
K962913 · Synthes (Usa) · Nov 1996
POWERCUT GOLD SURGICAL SYSTEM
K962022 · Baxter Healthcare Corp · Aug 1996
EXACTECH STERILE MODULAR DRILL BIT
K960720 · Exactech, Inc. · Apr 1996