Cleared Traditional

K931682 - CANNULATED MALLEOLAR SCREW

K931682 is an FDA 510(k) clearance for CANNULATED MALLEOLAR SCREW, manufactured by Onyx Medical Corp.. The device is a Class 2 Orthopedic device with product code KWK cleared through the Traditional 510(k) pathway after a 365-day FDA review.

K931682 · Onyx Medical Corp. · Orthopedic device
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Apr 1994
Decision
365d
Days
Class 2
Risk

K931682 is an FDA 510(k) clearance for the CANNULATED MALLEOLAR SCREW. Classified as Appliance, Nail/blade/plate Combination, Single Component (product code KWK), Class II - Special Controls.

Submitted by Onyx Medical Corp. (Memphis, US). The FDA issued a Cleared decision on April 5, 1994 after a review of 365 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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. Elevated predicate reliance profile. 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 Onyx Medical Corp. devices

FDA 510(k) Submission Details - K931682

510(k) Number K931682 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 05, 1993
Decision Date April 05, 1994
Days to Decision 365 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
243d slower than avg
Panel avg: 122d · This submission: 365d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWK Device Classification - Class 2, Special Controls

Product Code KWK Appliance, Nail/blade/plate Combination, Single Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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.