Cleared Traditional

K063326 - CONMED LINVATEC 24K IRRIGATION SYSTEM

K063326 is an FDA 510(k) clearance for CONMED LINVATEC 24K IRRIGATION SYSTEM, manufactured by Conmed Linvatec. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K063326 · Conmed Linvatec · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jan 2007
Decision
89d
Days
Class 2
Risk

K063326 is an FDA 510(k) clearance for the CONMED LINVATEC 24K IRRIGATION SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Conmed Linvatec (Largo, US). The FDA issued a Cleared decision on January 31, 2007 after a review of 89 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Conmed Linvatec devices

FDA 510(k) Submission Details - K063326

510(k) Number K063326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2006
Decision Date January 31, 2007
Days to Decision 89 days
Submission Type Traditional
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
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 548
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K063326.
MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPOWER ORALMAX HIGH SPEED DRILL
K072706 · Conmed Linvatec · Oct 2007
SMITH & NEPHEW ARTHROSCOPE
K072675 · Smith & Nephew, Inc. · Oct 2007
CONMED LINVATEC SMART GUARD IRRIGATOR
K070233 · Conmed Linvatec · Apr 2007
SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM
K062849 · Smith & Nephew, Inc. · Jan 2007
X-STEN MILD TOOL KIT, MODEL MTK-0001
K062038 · X-Sten Corp. · Dec 2006
FLOSIMPLE ARTHROSCOPY PUMP A120
K062380 · W.O.M. World of Medicine AG · Dec 2006