Cleared Traditional

K930109 - KOMET MEDICAL SURGICAL POWER ACCESORIES (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K930109 · Brassler USA · Orthopedic device
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Aug 1993
Decision
226d
Days
Class 2
Risk

K930109 is an FDA 510(k) clearance for the KOMET MEDICAL SURGICAL POWER ACCESORIES. Classified as Instrument, Surgical, Sonic And Accessory/attachment (product code JDX), Class II - Special Controls.

Submitted by Brassler USA (Great Neck, US). The FDA issued a Cleared decision on August 25, 1993 after a review of 226 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4580 - 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.

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Submission Details

510(k) Number K930109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1993
Decision Date August 25, 1993
Days to Decision 226 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
104d slower than avg
Panel avg: 122d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDX Instrument, Surgical, Sonic And Accessory/attachment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.4580
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.