Cleared Special

K041233 - ARTHROJET XT

K041233 is an FDA 510(k) clearance for ARTHROJET XT, manufactured by Hydrocision, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Special 510(k) pathway after a 79-day FDA review.

K041233 · Hydrocision, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
79d
Days
Class 2
Risk

K041233 is an FDA 510(k) clearance for the ARTHROJET XT. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Hydrocision, Inc. (Hopkonton, US). The FDA issued a Cleared decision on July 28, 2004 after a review of 79 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 Hydrocision, Inc. devices

FDA 510(k) Submission Details - K041233

510(k) Number K041233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2004
Decision Date July 28, 2004
Days to Decision 79 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
43d faster than avg
Panel avg: 122d · This submission: 79d
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 414
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