Cleared Special

K072706 - MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPOWER ORALMAX HIGH SPEED DRILL

K072706 is an FDA 510(k) clearance for MICROCHOICE DRILLS AND SAWS, manufactured by Conmed Linvatec. The device is a Class 2 Orthopedic device with product code HRX cleared through the Special 510(k) pathway after a 30-day FDA review.

K072706 · Conmed Linvatec · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
30d
Days
Class 2
Risk

K072706 is an FDA 510(k) clearance for the MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPOWER ORALMAX H.... Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Conmed Linvatec (Largo, US). The FDA issued a Cleared decision on October 24, 2007 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K072706

510(k) Number K072706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2007
Decision Date October 24, 2007
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 684
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K072706.
INNERVUE DIAGNOSTIC SCOPE SYSTEM
K072879 · Biomet Orthopedics, Inc. · Jan 2008
ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0
K070021 · Jg Medical Products, LLC · Dec 2007
ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006
K070874 · Arthro Kinetics, Inc. · Nov 2007
SMITH & NEPHEW ARTHROSCOPE
K072675 · Smith & Nephew, Inc. · Oct 2007
CONMED LINVATEC SMART GUARD IRRIGATOR
K070233 · Conmed Linvatec · Apr 2007
CONMED LINVATEC 24K IRRIGATION SYSTEM
K063326 · Conmed Linvatec · Jan 2007
K072706 · MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPOWER ORALMAX HIGH SPEED DRILL
Download PDF FDA Summary Conmed Linvatec