Cleared Traditional

K903246 - SIDE PLATE

K903246 is an FDA 510(k) clearance for SIDE PLATE, manufactured by Onyx Medical Corp.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K903246 · Onyx Medical Corp. · Orthopedic device
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Jul 1990
Decision
6d
Days
Class 2
Risk

K903246 is an FDA 510(k) clearance for the SIDE PLATE. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Onyx Medical Corp. (Memphis, US). The FDA issued a Cleared decision on July 30, 1990 after a review of 6 days - a notably fast clearance cycle.

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: 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 Onyx Medical Corp. devices

FDA 510(k) Submission Details - K903246

510(k) Number K903246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1990
Decision Date July 30, 1990
Days to Decision 6 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
116d faster than avg
Panel avg: 122d · This submission: 6d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTT Device Classification - Class 2, Special Controls

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple 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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 287
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K903246.
TRAUMAFIX (TM) EXTERNAL FIXATOR
K914558 · Synthes (Usa) · Jan 1992
INTRAMEDULLARY HIP SCREW, MODIFICATION
K912162 · Smith & Nephew Richards, Inc. · Aug 1991
KIRSCHNER BLADE PLATE SYSTEM OR R.A.B. BLADE PLATE
K901234 · Kirschner Medical Corp. · Oct 1990
BLADE PLATE
K903250 · Onyx Medical Corp. · Jul 1990
JEWETT HIP NAIL
K903251 · Onyx Medical Corp. · Jul 1990
ALTA LAG SCREW AND COMPRESSION SCREW
K900584 · Howmedica Corp. · Apr 1990