Cleared Traditional

K043106 - PINN-ACL CROSSPIN

K043106 is the FDA 510(k) clearance for PINN-ACL CROSSPIN by Linvatec Corp.. It is a Class 2 Orthopedic device (product code HTY) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K043106 · Linvatec Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
71d
Days
Class 2
Risk

K043106 is an FDA 510(k) clearance for the PINN-ACL CROSSPIN. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on January 19, 2005 after a review of 71 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 Linvatec Corp. devices

Submission Details

510(k) Number K043106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2004
Decision Date January 19, 2005
Days to Decision 71 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
51d faster than avg
Panel avg: 122d · This submission: 71d
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 K043106.
ARTHREX CROSSPIN, MODEL AR-1964P
K063719 · Arthrex, Inc. · Mar 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
HUMERAL STAPLE
K041355 · Smith & Nephew, Inc. · Jul 2004
HANSSON PIN SYSTEM
K033968 · Howmedica Osteonics Corp. · Feb 2004
ACE NANCY NAIL
K032687 · DePuy Orthopaedics, Inc. · Oct 2003