Cleared Traditional

K142645 - Avenue T TLIF Cage

K142645 is an FDA 510(k) clearance for Avenue T TLIF Cage, manufactured by Ldr Spine USA, Inc.. The device is a Class 2 Orthopedic device with product code OVD cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K142645 · Ldr Spine USA, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Jun 2015
Decision
267d
Days
Class 2
Risk

K142645 is an FDA 510(k) clearance for the Avenue T TLIF Cage. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Ldr Spine USA, Inc. (Austin, US). The FDA issued a Cleared decision on June 11, 2015 after a review of 267 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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 Ldr Spine USA, Inc. devices

FDA 510(k) Submission Details - K142645

510(k) Number K142645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2014
Decision Date June 11, 2015
Days to Decision 267 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
145d slower than avg
Panel avg: 122d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OVD Device Classification - Class 2, Special Controls

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 165
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K142645.
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AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System
K143163 · Stryker Corporation · Jan 2015