Cleared Traditional

K102215 - KIRSCHNER WIRES, STEINMAN PINS

K102215 is an FDA 510(k) clearance for KIRSCHNER WIRES, manufactured by Evergreen Orthopedic Research Lab. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K102215 · Evergreen Orthopedic Research Lab · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
95d
Days
Class 2
Risk

K102215 is an FDA 510(k) clearance for the KIRSCHNER WIRES, STEINMAN PINS. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Evergreen Orthopedic Research Lab (Kirkland, US). The FDA issued a Cleared decision on November 9, 2010 after a review of 95 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Evergreen Orthopedic Research Lab devices

FDA 510(k) Submission Details - K102215

510(k) Number K102215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2010
Decision Date November 09, 2010
Days to Decision 95 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
27d faster than avg
Panel avg: 122d · This submission: 95d
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 160
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K102215.
PCL TIGHTROPE
K110123 · Arthrex, Inc. · Apr 2011
VERTICOR K-WIRE SYSTEM
K110047 · Verticor, Ltd. · Feb 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
APTUS K-WIRE SYSTEM
K092038 · Medartis AG · Sep 2009