Cleared Traditional

K041824 - X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM

K041824 is an FDA 510(k) clearance for X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM, manufactured by Future Medical Systems, SA. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K041824 · Future Medical Systems, SA · Orthopedic device
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Jan 2005
Decision
185d
Days
Class 2
Risk

K041824 is an FDA 510(k) clearance for the X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Future Medical Systems, SA (St. Jeannet, FR). The FDA issued a Cleared decision on January 7, 2005 after a review of 185 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 Future Medical Systems, SA devices

FDA 510(k) Submission Details - K041824

510(k) Number K041824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2004
Decision Date January 07, 2005
Days to Decision 185 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 122d · This submission: 185d
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 500
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K041824.
SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS
K050580 · Smith & Nephew Endoscopy, Inc. · Apr 2005
EQUESTRA FLUID DELIVERY SYSTEM
K043568 · Medtronic Sofamor Danek · Jan 2005
SMITH & NEPHEW VIDEOARTHROSCOPE
K043395 · Smith & Nephew, Inc. · Jan 2005
EQUESTRA FLUID DELIVERY SYSTEM
K040483 · Medtronic Sofamor Danek, Inc. · Jul 2004
SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
K040612 · Disc-O-Tech Medical Technologies, Ltd. · Jun 2004
SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
K040939 · Disc-O-Tech Medical Technologies, Ltd. · May 2004