Cleared Abbreviated

K070561 - KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES

K070561 is an FDA 510(k) clearance for KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES, manufactured by Teleflex Medical. The device is a Class 2 Orthopedic device with product code HTY cleared through the Abbreviated 510(k) pathway after a 87-day FDA review.

K070561 · Teleflex Medical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
87d
Days
Class 2
Risk

K070561 is an FDA 510(k) clearance for the KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Teleflex Medical (Bannockburn, US). The FDA issued a Cleared decision on May 25, 2007 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Teleflex Medical devices

FDA 510(k) Submission Details - K070561

510(k) Number K070561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2007
Decision Date May 25, 2007
Days to Decision 87 days
Submission Type Abbreviated
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
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Standards-based clearance path.

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 187
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K070561.
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
ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES
K070555 · Orthopro, LLC · Jul 2007
ARTHREX CROSSPIN, MODEL AR-1964P
K063719 · Arthrex, Inc. · Mar 2007
STORM OPERATING KIT, MODEL 1-10-0
K061607 · Intelligent Orthopaedics, Ltd. · Jul 2006
ACTIVAPIN
K061164 · Bioretec, Ltd. · Jul 2006