Cleared Traditional

6.5MM HEX HANDLE (K841969) - FDA 510(k) Clearance

Class I Orthopedic device.

K841969 · Stainless Mfg., Inc. · Orthopedic device
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Jun 1984
Decision
36d
Days
Class 1
Risk

K841969 is an FDA 510(k) clearance for the 6.5MM HEX HANDLE. Classified as Orthopedic Manual Surgical Instrument (product code LXH), Class I - General Controls.

Submitted by Stainless Mfg., Inc. (Mchenry, US). The FDA issued a Cleared decision on June 19, 1984 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stainless Mfg., Inc. devices

Submission Details

510(k) Number K841969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1984
Decision Date June 19, 1984
Days to Decision 36 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 122d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXH Orthopedic Manual Surgical Instrument
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
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 - LXH Orthopedic Manual Surgical Instrument

All 8
Devices cleared under the same product code (LXH) and FDA review panel - the closest regulatory comparables to K841969.
STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH
K941605 · Stryker Corp. · Aug 1994
TENSIOMETER
K883694 · W.L. Gore & Associates, Inc. · Nov 1988
HENNING MENISCAL SUTURE KIT
K843942 · Stryker Corp. · Apr 1985
HOWMEDICA KNEE BRUSH
K803127 · Howmedica Corp. · Feb 1981
JACOB CHUCK
K802694 · Richard Wolf Medical Instruments Corp. · Nov 1980