Cleared Traditional

K043349 - OPEN RADIOTRANSPARENT INTERSOMATIC IMPL...

K043349 is an FDA 510(k) clearance for OPEN RADIOTRANSPARENT INTERSOMATIC IMPL..., manufactured by Ldr Spine USA. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 205-day FDA review.

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

FDA 510(k) Submission Details - K043349

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
Combination Product No
PCCP Authorized No
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.

MQP Device Classification - Class 2, Special Controls

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 189
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K043349.
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT
K051978 · Implex Corp. · Sep 2005
SEMIAL SPINAL IMPLANT
K051659 · Signus Medizintechnik GmbH · Jul 2005
MC+ PARTIAL VBR
K043479 · Ldr Spine USA · Jun 2005
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1
K051196 · Implex Corp. · Jun 2005
CONSTRUX MINI PEEK VBR SYSTEM
K051246 · Blackstone Medical, Inc. · Jun 2005
BASIS VERTEBRAL BODY SPACER
K051105 · Medtronic Sofamor Danek · Jun 2005