Cleared Traditional

K931686 - MALLEOLAR SCREW

K931686 is an FDA 510(k) clearance for MALLEOLAR SCREW, manufactured by Onyx Medical Corp.. The device is a Class 2 Orthopedic device with product code KTW cleared through the Traditional 510(k) pathway after a 365-day FDA review.

K931686 · Onyx Medical Corp. · Orthopedic device
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Apr 1994
Decision
365d
Days
Class 2
Risk

K931686 is an FDA 510(k) clearance for the MALLEOLAR SCREW. Classified as Appliance, Fixation, Nail/blade/plate Combination, Single Component (product code KTW), 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 - K931686

510(k) Number K931686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1993
Decision Date April 05, 1994
Days to Decision 365 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
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.

KTW Device Classification - Class 2, Special Controls

Product Code KTW Appliance, Fixation, 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.

Regulatory Peers - KTW Appliance, Fixation, Nail/blade/plate Combination, Single Component

All 22
Devices cleared under the same product code (KTW) and FDA review panel - the closest regulatory comparables to K931686.
3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP)
K992837 · Synthes (Usa) · Oct 1999
CONCISE COMPRESSION HIP SCREW SYSTEM (STERILE)
K982390 · Wrightmedicaltechnologyinc · Sep 1998
SYNTHES CANNULATED ANGLE BLADE PLATE
K954289 · Synthes (Usa) · Nov 1995
TORUS EXTERNAL FIXATION SYSTEM
K925635 · Zimmer, Inc. · Jun 1993
ANGLED BLADE PLATE
K914546 · Synthes (Usa) · Nov 1991
LEVTECH SMALL BONE PLATE
K893928 · Buckman Co., Inc. · Nov 1989