Cleared Special

K070233 - CONMED LINVATEC SMART GUARD IRRIGATOR

K070233 is an FDA 510(k) clearance for CONMED LINVATEC SMART GUARD IRRIGATOR, 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 67-day FDA review.

K070233 · Conmed Linvatec · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
67d
Days
Class 2
Risk

K070233 is an FDA 510(k) clearance for the CONMED LINVATEC SMART GUARD IRRIGATOR. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Conmed Linvatec (Largo, US). The FDA issued a Cleared decision on April 2, 2007 after a review of 67 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.

View all Conmed Linvatec devices

FDA 510(k) Submission Details - K070233

510(k) Number K070233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2007
Decision Date April 02, 2007
Days to Decision 67 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 122d · This submission: 67d
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 394
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K070233.
POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES
K080617 · Richard Wolf Medical Instruments Corp. · Jun 2008
INNERVUE DIAGNOSTIC SCOPE SYSTEM
K072879 · Biomet Orthopedics, Inc. · Jan 2008
SMITH & NEPHEW ARTHROSCOPE
K072675 · Smith & Nephew, Inc. · Oct 2007
SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM
K062849 · Smith & Nephew, Inc. · Jan 2007
MODIFICATION TO ENDIUS ATAVI SYSTEM
K061345 · Endius, Inc. · Jun 2006
MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW
K060198 · Linvatec Corp. · May 2006