Cleared Traditional

K043339 - REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L (FDA 510(k) Clearance)

Also includes:
(PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K043339 · Xtremi-T, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
136d
Days
Class 2
Risk

K043339 is an FDA 510(k) clearance for the REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Xtremi-T, LLC (Lawrenceville, US). The FDA issued a Cleared decision on April 18, 2005 after a review of 136 days - within the typical 510(k) review window.

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 Xtremi-T, LLC devices

Submission Details

510(k) Number K043339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2004
Decision Date April 18, 2005
Days to Decision 136 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
14d slower than avg
Panel avg: 122d · This submission: 136d
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 203
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