Cleared Abbreviated

K031772 - TI FENESTRATED PLATE (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K031772 · Interpore Cross Intl. · Orthopedic device
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Sep 2003
Decision
88d
Days
Class 2
Risk

K031772 is an FDA 510(k) clearance for the TI FENESTRATED PLATE. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Interpore Cross Intl. (Irvine, US). The FDA issued a Cleared decision on September 5, 2003 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Interpore Cross Intl. devices

Submission Details

510(k) Number K031772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2003
Decision Date September 05, 2003
Days to Decision 88 days
Submission Type Abbreviated
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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.