Cleared Traditional

K112675 - ARROW-LOK DIGITAL SYSTEM

K112675 is an FDA 510(k) clearance for ARROW-LOK DIGITAL SYSTEM, manufactured by Arrowhead Medical Device Technologies, LLC. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K112675 · Arrowhead Medical Device Technologies, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
89d
Days
Class 2
Risk

K112675 is an FDA 510(k) clearance for the ARROW-LOK DIGITAL SYSTEM. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Arrowhead Medical Device Technologies, LLC (Collierville, US). The FDA issued a Cleared decision on December 12, 2011 after a review of 89 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 Arrowhead Medical Device Technologies, LLC devices

FDA 510(k) Submission Details - K112675

510(k) Number K112675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2011
Decision Date December 12, 2011
Days to Decision 89 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 122d · This submission: 89d
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 111
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K112675.
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