Cleared Traditional

K850789 - FLUTED SUCTION MENISCAL CUTTER

K850789 is an FDA 510(k) clearance for FLUTED SUCTION MENISCAL CUTTER, manufactured by T. Korossurgical Instruments Corp.. The device is a Class 1 Orthopedic device with product code KIJ cleared through the Traditional 510(k) pathway after a 122-day FDA review.

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

FDA 510(k) Submission Details - K850789

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 122d · This submission: 122d
Pathway characteristics
Predicate-based equivalence.

KIJ Device Classification - Class 1, General Controls

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.

Regulatory Peers - KIJ Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment

All 11
Devices cleared under the same product code (KIJ) and FDA review panel - the closest regulatory comparables to K850789.
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