Cleared Traditional

K073674 - BONE FIXATION WIRE (KIRSCHNER WIRE)

K073674 is an FDA 510(k) clearance for BONE FIXATION WIRE (KIRSCHNER WIRE), manufactured by Signal Medical Corp.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K073674 · Signal Medical Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
87d
Days
Class 2
Risk

K073674 is an FDA 510(k) clearance for the BONE FIXATION WIRE (KIRSCHNER WIRE). Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Signal Medical Corp. (Marysville, US). The FDA issued a Cleared decision on March 24, 2008 after a review of 87 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 Signal Medical Corp. devices

FDA 510(k) Submission Details - K073674

510(k) Number K073674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2007
Decision Date March 24, 2008
Days to Decision 87 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 122d · This submission: 87d
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 121
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K073674.
APTUS K-WIRE SYSTEM
K092038 · Medartis AG · Sep 2009
BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685
K083490 · Biopro, Inc. · Mar 2009
ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
K082375 · OrthoPediatrics Corp. · Oct 2008
KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES
K070561 · Teleflex Medical · May 2007
ARTHREX CROSSPIN, MODEL AR-1964P
K063719 · Arthrex, Inc. · Mar 2007
ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT
K052736 · Arthrex, Inc. · Nov 2005