Cleared Traditional

ARGUS ARTHROSCOPY INSTRUMENT SYSTEM (K950242) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K950242 · Argus Medical Co., Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
115d
Days
Class 2
Risk

K950242 is an FDA 510(k) clearance for the ARGUS ARTHROSCOPY INSTRUMENT SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Argus Medical Co., Inc. (Walnut, US). The FDA issued a Cleared decision on May 15, 1995 after a review of 115 days - within the typical 510(k) review window.

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 Argus Medical Co., Inc. devices

Submission Details

510(k) Number K950242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1995
Decision Date May 15, 1995
Days to Decision 115 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
7d faster than avg
Panel avg: 122d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K950242.
KARL STORZ UNIDRIVE SHAVER, ARTHROSCOPY BLADES
K952192 · KARL STORZ Endoscopy-America, Inc. · Jun 1995
GORE SMOOTHER GUIDED RASP
K951163 · W.L. Gore & Associates, Inc. · Jun 1995
ARTHROSCOPE FOR SMALL JOINT AFTER FELDKAMP, MODEL 8871.011
K940179 · Richard Wolf Medical Instruments Corp. · May 1995
KSEA DISPOSABLE TUBING SET FOR THE ARTHROPUMP
K950561 · KARL STORZ Endoscopy-America, Inc. · May 1995
BENCHMARK SERIES ARTHROSCCOPIC INSTRUMENTS
K946151 · Depuy, Inc. · May 1995
THE KARL STORZ ARTHROPUMP
K942298 · KARL STORZ Endoscopy-America, Inc. · Jan 1995