Cleared Traditional

K070874 - ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006

Also marketed or referenced as:
ACCESSORIES FOR MR GENERATOR

K070874 is an FDA 510(k) clearance for ARTHRO KINETICS VESALIUS MR GENERATOR, manufactured by Arthro Kinetics, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K070874 · Arthro Kinetics, Inc. · Orthopedic device
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Nov 2007
Decision
218d
Days
Class 2
Risk

K070874 is an FDA 510(k) clearance for the ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Arthro Kinetics, Inc. (Boston, US). The FDA issued a Cleared decision on November 2, 2007 after a review of 218 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.

View all Arthro Kinetics, Inc. devices

FDA 510(k) Submission Details - K070874

510(k) Number K070874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2007
Decision Date November 02, 2007
Days to Decision 218 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 122d · This submission: 218d
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 480
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K070874.
SOPRO 670 ARTHROSCOPIC PUMP
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K072879 · Biomet Orthopedics, Inc. · Jan 2008
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K072706 · Conmed Linvatec · Oct 2007
SMITH & NEPHEW ARTHROSCOPE
K072675 · Smith & Nephew, Inc. · Oct 2007
CONMED LINVATEC SMART GUARD IRRIGATOR
K070233 · Conmed Linvatec · Apr 2007