Cleared Traditional

K110047 - VERTICOR K-WIRE SYSTEM

K110047 is an FDA 510(k) clearance for VERTICOR K-WIRE SYSTEM, manufactured by Verticor, Ltd.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K110047 · Verticor, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
53d
Days
Class 2
Risk

K110047 is an FDA 510(k) clearance for the VERTICOR K-WIRE SYSTEM. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Verticor, Ltd. (Round Rock, US). The FDA issued a Cleared decision on February 28, 2011 after a review of 53 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 Verticor, Ltd. devices

FDA 510(k) Submission Details - K110047

510(k) Number K110047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2011
Decision Date February 28, 2011
Days to Decision 53 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
69d faster than avg
Panel avg: 122d · This submission: 53d
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 K110047.
INTRAOSSEOUS FIXATION SYSTEM
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PCL TIGHTROPE
K110123 · Arthrex, Inc. · Apr 2011
ACL TIGHTROPE DOUBLE BUNDLE
K101837 · Arthrex, Inc. · Dec 2010
ACL TIGHTROPE
K100652 · Arthrex, Inc. · Jun 2010
STRYKER SONICPIN SYSTEM
K091955 · Howmedica Osteonics Corp. · Apr 2010