Cleared Traditional

K931076 - ARTHOSCOPE AND ACCESSORIES

K931076 is an FDA 510(k) clearance for ARTHOSCOPE AND ACCESSORIES, manufactured by Meditron Devices, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 394-day FDA review.

K931076 · Meditron Devices, Inc. · Orthopedic device
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Mar 1994
Decision
394d
Days
Class 2
Risk

K931076 is an FDA 510(k) clearance for the ARTHOSCOPE AND ACCESSORIES. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Meditron Devices, Inc. (Hackensack, US). The FDA issued a Cleared decision on March 31, 1994 after a review of 394 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Meditron Devices, Inc. devices

FDA 510(k) Submission Details - K931076

510(k) Number K931076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1993
Decision Date March 31, 1994
Days to Decision 394 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
272d slower than avg
Panel avg: 122d · This submission: 394d
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 566
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K931076.
ARTHREX ARTHROSCOPE
K921119 · Arthrex, Inc. · Apr 1994
LINVATEC POWERLINK SURGICAL SHAVING SYSTEM
K934379 · Linvatec Corp. · Apr 1994
SHAVER BLADE SET
K940075 · Arthrex, Inc. · Apr 1994
MOD. PERCUTANEOUS ARTHROSCOPIC MICRO DISCECTOMY
K922519 · Smith & Nephew, Inc. · Mar 1994
AUTO SUTURE DISPOSABLE ARTHROSCOPIC TROCAR AND SLEEVE
K934720 · United States Surgical, A Division of Tyco Healthc · Mar 1994
ARTHTOTEK PRECISION HAND INSTRUMENTATION
K933070 · Biomet, Inc. · Mar 1994