Cleared Traditional

K850789 - FLUTED SUCTION MENISCAL CUTTER (FDA 510(k) Clearance)

Class I Orthopedic device.

K850789 · T. Korossurgical Instruments Corp. · Orthopedic device
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Jun 1985
Decision
122d
Days
Class 1
Risk

K850789 is an FDA 510(k) clearance for the FLUTED SUCTION MENISCAL CUTTER. Classified as Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment (product code KIJ), Class I - General Controls.

Submitted by T. Korossurgical Instruments Corp. (Westlake, US). The FDA issued a Cleared decision on June 28, 1985 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - 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 T. Korossurgical Instruments Corp. devices

Submission Details

510(k) Number K850789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1985
Decision Date June 28, 1985
Days to Decision 122 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 122d · This submission: 122d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIJ Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.