Cleared Traditional

K080617 - POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES

K080617 is an FDA 510(k) clearance for POWER DRIVE ART1 2304 WITH MOTOR HANDLES, manufactured by Richard Wolf Medical Instruments Corp.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K080617 · Richard Wolf Medical Instruments Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
115d
Days
Class 2
Risk

K080617 is an FDA 510(k) clearance for the POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on June 27, 2008 after a review of 115 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K080617

510(k) Number K080617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2008
Decision Date June 27, 2008
Days to Decision 115 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
7d faster than avg
Panel avg: 122d · This submission: 115d
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 684
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K080617.
LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002
K082194 · Laurimed, LLC · Aug 2008
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE
K081051 · Spine View, Inc. · Aug 2008
SOPRO 670 ARTHROSCOPIC PUMP
K080122 · Sopro · Jul 2008
X-VOID, SPIDER
K072198 · Sintea Biotech, Inc. · Jun 2008
HENKE SASS WOLF OF AMERICA ARTHROSCOPE
K080560 · Henke Sass Wolf of America, Inc. · Mar 2008
INNERVUE DIAGNOSTIC SCOPE SYSTEM
K072879 · Biomet Orthopedics, Inc. · Jan 2008
K080617 · POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES
Download PDF FDA Summary Richard Wolf Medical …