Cleared Traditional

OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI) (K043349) - FDA 510(k) Clearance

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

K043349 · Ldr Spine USA · Orthopedic device
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Jun 2005
Decision
205d
Days
Class 2
Risk

K043349 is an FDA 510(k) clearance for the OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI). Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Ldr Spine USA (Austin, US). The FDA issued a Cleared decision on June 29, 2005 after a review of 205 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 devices

Submission Details

510(k) Number K043349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2004
Decision Date June 29, 2005
Days to Decision 205 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
83d slower than avg
Panel avg: 122d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 40
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K043349.
AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
K060762 · Aesculap, Inc. · Sep 2006
RETAIN RADIOLUCENT SPACER
K061380 · Globus Medical, Inc. · Jun 2006
XPAND RADIOLUCENT CORPECTOMY SPACER
K060665 · Globus Medical, Inc. · May 2006
XPAND CORPECTOMY SPACER
K050850 · Globus Medical, Inc. · May 2005
STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM
K033837 · Howmedica Osteonics Corp. · Jan 2004
SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW)
K024364 · Synthes (Usa) · Mar 2003