Cleared Traditional

K903254 - U.S. TYPE CRUCIATE SLOT BONE SCREW

K903254 is an FDA 510(k) clearance for U.S. TYPE CRUCIATE SLOT BONE SCREW, manufactured by Onyx Medical Corp.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K903254 · Onyx Medical Corp. · Orthopedic device
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Aug 1990
Decision
16d
Days
Class 2
Risk

K903254 is an FDA 510(k) clearance for the U.S. TYPE CRUCIATE SLOT BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), 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 888.3040 - 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 - K903254

510(k) Number K903254 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
Combination Product No
PCCP Authorized No
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.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 640
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K903254.
UNIVERSAL COMPRESSION SCREW
K904809 · Howmedica Corp. · Jun 1991
ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM
K911398 · Howmedica Corp. · Jun 1991
CANCELLOUS SCREW
K903253 · Onyx Medical Corp. · Aug 1990
CORTICAL BONE SCREW (EUROPEAN STYLE)
K903255 · Onyx Medical Corp. · Aug 1990
HAGIE PIN
K903258 · Onyx Medical Corp. · Aug 1990
KNOWLES PIN
K903259 · Onyx Medical Corp. · Aug 1990