Cleared Traditional

K915776 - KNEE PROSTHESIS DRIVER (FDA 510(k) Clearance)

Class I Orthopedic device.

K915776 · Kim-Med, Inc. · Orthopedic device
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Jun 1992
Decision
170d
Days
Class 1
Risk

K915776 is an FDA 510(k) clearance for the KNEE PROSTHESIS DRIVER. Classified as Driver, Prosthesis (product code HWR), Class I - General Controls.

Submitted by Kim-Med, Inc. (Kansas City, US). The FDA issued a Cleared decision on June 11, 1992 after a review of 170 days - an extended review 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: 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 Kim-Med, Inc. devices

Submission Details

510(k) Number K915776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1991
Decision Date June 11, 1992
Days to Decision 170 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
48d slower than avg
Panel avg: 122d · This submission: 170d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HWR Driver, Prosthesis
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.