Cleared Traditional

K063719 - ARTHREX CROSSPIN

K063719 is the FDA 510(k) clearance for ARTHREX CROSSPIN by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code HTY) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K063719 · Arthrex, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2007
Decision
81d
Days
Class 2
Risk

K063719 is an FDA 510(k) clearance for the ARTHREX CROSSPIN, MODEL AR-1964P. 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 March 6, 2007 after a review of 81 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

Submission Details

510(k) Number K063719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2006
Decision Date March 06, 2007
Days to Decision 81 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
41d faster than avg
Panel avg: 122d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 96
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K063719.
BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685
K083490 · Biopro, Inc. · Mar 2009
ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
K082375 · OrthoPediatrics Corp. · Oct 2008
KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES
K070561 · Teleflex Medical · May 2007
ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT
K052736 · Arthrex, Inc. · Nov 2005
ARTHREX BIO-PIN
K050259 · Arthrex, Inc. · May 2005
PINN-ACL CROSSPIN
K043106 · Linvatec Corp. · Jan 2005