Cleared Traditional

K112599 - INSURGICAL SINGLE USE POWER EQUIPMENT

K112599 is an FDA 510(k) clearance for INSURGICAL SINGLE USE POWER EQUIPMENT, manufactured by Insurgical, LLC. The device is a Class 1 Orthopedic device with product code KIJ cleared through the Traditional 510(k) pathway after a 426-day FDA review.

K112599 · Insurgical, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
426d
Days
Class 1
Risk

K112599 is an FDA 510(k) clearance for the INSURGICAL SINGLE USE POWER EQUIPMENT. Classified as Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment (product code KIJ), Class I - General Controls.

Submitted by Insurgical, LLC (Austin, US). The FDA issued a Cleared decision on November 6, 2012 after a review of 426 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Insurgical, LLC devices

FDA 510(k) Submission Details - K112599

510(k) Number K112599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2011
Decision Date November 06, 2012
Days to Decision 426 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
304d slower than avg
Panel avg: 122d · This submission: 426d
Pathway characteristics
Predicate-based equivalence.

KIJ Device Classification - Class 1, General Controls

Product Code KIJ Instrument, Surgical, Orthopedic, Dc-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 - KIJ Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment

All 15
Devices cleared under the same product code (KIJ) and FDA review panel - the closest regulatory comparables to K112599.
SMARTO
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STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT
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ACUMED BONE GRAFT SYSTEM
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ARTHREX GRAFT HARVESTING KIT
K941285 · Arthrex, Inc. · Nov 1994
THE OSTEOMED B POWER SYSTEM AND ACCESSORIES
K933101 · Osteomed Corp. · Nov 1994