Cleared Traditional

K070555 - ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES

K070555 is an FDA 510(k) clearance for ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES, manufactured by Orthopro, LLC. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K070555 · Orthopro, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
136d
Days
Class 2
Risk

K070555 is an FDA 510(k) clearance for the ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Orthopro, LLC (Vancouver, US). The FDA issued a Cleared decision on July 13, 2007 after a review of 136 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.

FDA 510(k) Submission Details - K070555

510(k) Number K070555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2007
Decision Date July 13, 2007
Days to Decision 136 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 122d · This submission: 136d
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 197
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K070555.
ARC SURGICAL BIOTRAK PIN SYSTEM
K071616 · Arc Surgical, LLC · Dec 2007
ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)
K071863 · Bioretec, Ltd. · Aug 2007
MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSE
K070598 · Memometal Technologies · Jul 2007
KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES
K070561 · Teleflex Medical · May 2007
ARTHREX CROSSPIN, MODEL AR-1964P
K063719 · Arthrex, Inc. · Mar 2007
STORM OPERATING KIT, MODEL 1-10-0
K061607 · Intelligent Orthopaedics, Ltd. · Jul 2006