Cleared Special

ARTHOSCOPY PUMP A115 (K033927) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K033927 · W.O.M. World of Medicine AG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
28d
Days
Class 2
Risk

K033927 is an FDA 510(k) clearance for the ARTHOSCOPY PUMP A115. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by W.O.M. World of Medicine AG (Alexandria, US). The FDA issued a Cleared decision on January 15, 2004 after a review of 28 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 W.O.M. World of Medicine AG devices

Submission Details

510(k) Number K033927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2003
Decision Date January 15, 2004
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 178
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K033927.
SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM
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K043568 · Medtronic Sofamor Danek · Jan 2005
SMITH & NEPHEW VIDEOARTHROSCOPE
K043395 · Smith & Nephew, Inc. · Jan 2005
POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851
K030082 · Richard Wolf Medical Instruments Corp. · Oct 2003
INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY
K031605 · Smith & Nephew, Inc. · Jun 2003
ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475
K024291 · Arthrex, Inc. · Mar 2003