Cleared Traditional

K100926 - ARROWHEAD FIXATION DEVICE

K100926 is an FDA 510(k) clearance for ARROWHEAD FIXATION DEVICE, manufactured by Arrow Products, Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K100926 · Arrow Products, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
207d
Days
Class 2
Risk

K100926 is an FDA 510(k) clearance for the ARROWHEAD FIXATION DEVICE. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Arrow Products, Inc. (Hampton, US). The FDA issued a Cleared decision on October 29, 2010 after a review of 207 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Arrow Products, Inc. devices

FDA 510(k) Submission Details - K100926

510(k) Number K100926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2010
Decision Date October 29, 2010
Days to Decision 207 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
85d slower than avg
Panel avg: 122d · This submission: 207d
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 121
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K100926.
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