Cleared Traditional

K903264 - K-WIRE

K903264 is an FDA 510(k) clearance for K-WIRE, manufactured by Onyx Medical Corp.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K903264 · Onyx Medical Corp. · Orthopedic device
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Jul 1990
Decision
6d
Days
Class 2
Risk

K903264 is an FDA 510(k) clearance for the K-WIRE. Classified as Pin, Fixation, Smooth (product code HTY), 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 888.3040 - 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 - K903264

510(k) Number K903264 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.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
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 - HTY Pin, Fixation, Smooth

All 102
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K903264.
ACUFEX SMOOTH AND THREADED PINS
K931836 · Acufex Microsurgical, Inc. · Jun 1994
ORTHOPEDIC SMOOTH PIN FIXATION
K932348 · Osteomed Corp. · Mar 1994
ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION
K922766 · Acufex Microsurgical, Inc. · Jul 1993
STEINMAN PIN
K903265 · Onyx Medical Corp. · Jul 1990
BIOFIX* BIODEGRADABLE FIXATION ROD
K890902 · Davis & Geck, Inc. · Nov 1989
ACE BEADED K-WIRES ACE OLIVE WIRES
K895079 · Buckman Co., Inc. · Sep 1989