Cleared Traditional

K052736 - ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT

K052736 is an FDA 510(k) clearance for ARTHREX K-WIRE, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K052736 · Arthrex, Inc. · Orthopedic device
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Nov 2005
Decision
34d
Days
Class 2
Risk

K052736 is an FDA 510(k) clearance for the ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on November 3, 2005 after a review of 34 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 Arthrex, Inc. devices

FDA 510(k) Submission Details - K052736

510(k) Number K052736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2005
Decision Date November 03, 2005
Days to Decision 34 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
88d faster than avg
Panel avg: 122d · This submission: 34d
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 173
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K052736.
ACTIVAPIN
K061164 · Bioretec, Ltd. · Jul 2006
DSI PINS AND WIRES
K060654 · Delta Surgical Instruments, Inc. · Apr 2006
TRANSET SYSTEM
K060283 · Bonutti Research, Inc. · Feb 2006
SBI K-WIRES
K051605 · Small Bone Innovations, LLC · Aug 2005
ARTHREX BIO-PIN
K050259 · Arthrex, Inc. · May 2005
REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L
K043339 · Xtremi-T, LLC · Apr 2005