Cleared Traditional

BROAD SELF-COMPRESSING PLATE (K903252) - FDA 510(k) Clearance

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

K903252 · Onyx Medical Corp. · Orthopedic device
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Aug 1990
Decision
16d
Days
Class 2
Risk

K903252 is an FDA 510(k) clearance for the BROAD SELF-COMPRESSING PLATE. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Onyx Medical Corp. (Memphis, US). The FDA issued a Cleared decision on August 9, 1990 after a review of 16 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

Submission Details

510(k) Number K903252 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 24, 1990
Decision Date August 09, 1990
Days to Decision 16 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 122d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
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 - HRS Plate, Fixation, Bone

All 696
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K903252.
SYNTHES MAXILLOFACIAL TITANIUM MICRO SET
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K910482 · Howmedica Corp. · Jul 1991
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K905774 · Depuy, Inc. · Jun 1991
DUPONT DISTAL HUMERAL NAIL
K890939 · Howmedica Corp. · May 1989
ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL PLATE SYS
K885250 · Howmedica Corp. · Feb 1989
LUHR MICRO SYSTEM
K882454 · Howmedica Corp. · Aug 1988