Cleared Traditional

K940179 - ARTHROSCOPE FOR SMALL JOINT AFTER FELDKAMP, MODEL 8871.011

K940179 is an FDA 510(k) clearance for ARTHROSCOPE FOR SMALL JOINT AFTER FELDKAMP, manufactured by Richard Wolf Medical Instruments Corp.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 496-day FDA review.

K940179 · Richard Wolf Medical Instruments Corp. · Orthopedic device
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May 1995
Decision
496d
Days
Class 2
Risk

K940179 is an FDA 510(k) clearance for the ARTHROSCOPE FOR SMALL JOINT AFTER FELDKAMP, MODEL 8871.011. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on May 23, 1995 after a review of 496 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Richard Wolf Medical Instruments Corp. devices

FDA 510(k) Submission Details - K940179

510(k) Number K940179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1994
Decision Date May 23, 1995
Days to Decision 496 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
374d slower than avg
Panel avg: 122d · This submission: 496d
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 521
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K940179.
DAVOL ARTHRO-FLO 3
K951026 · Davol Inc., Sub. C. R. Bard, Inc. · Jun 1995
GORE SMOOTHER GUIDED RASP
K951163 · W.L. Gore & Associates, Inc. · Jun 1995
ARTHROSCOPIC TELESCOPES
K943052 · Karl Storz Endoscopy · May 1995
DANEK RIGID ARTHROSCOPE
K950501 · Sofamor Danek USA,Inc. · May 1995
KSEA DISPOSABLE TUBING SET FOR THE ARTHROPUMP
K950561 · KARL STORZ Endoscopy-America, Inc. · May 1995
INCLUSIVE ENDOSCOPE
K943356 · Danek Medical, Inc. · May 1995