Cleared Traditional

K083707 - ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE

K083707 is an FDA 510(k) clearance for ARTHREX DUAL WAVE ARTHROSCOPY FLUID MAN..., manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K083707 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
231d
Days
Class 2
Risk

K083707 is an FDA 510(k) clearance for the ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on August 3, 2009 after a review of 231 days - an extended review 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: 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 - K083707

510(k) Number K083707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2008
Decision Date August 03, 2009
Days to Decision 231 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
109d slower than avg
Panel avg: 122d · This submission: 231d
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 K083707.
MAXMORESPINE TOM STICK
K083552 · Hoogland Spine Products, GmbH · Oct 2009
SPINAL FORAMINOSCOPE
K082841 · Blazejewski Medi-Tech GmbH · Sep 2009
ARTHROSCOPE
K091398 · Orthopedic Sciences, Inc. · Aug 2009
MAXMORESPINE SPINAL SYSTEM
K090132 · Hoogland Spine Products, GmbH · Jun 2009
PERCUTANEOUS DISCECTOMY SYSTEM
K090815 · Laurimed, LLC · May 2009
XTEND-ST NUCLEUS REMOVAL SYSTEM, MODEL 9004
K090303 · Corespine Technologies, LLC · Apr 2009
K083707 · ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE
Download PDF FDA Summary Arthrex, Inc.