Cleared Traditional

K043479 - MC+ PARTIAL VBR

K043479 is an FDA 510(k) clearance for MC+ PARTIAL VBR, 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 196-day FDA review.

K043479 · Ldr Spine USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
196d
Days
Class 2
Risk

K043479 is an FDA 510(k) clearance for the MC+ PARTIAL VBR. 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 30, 2005 after a review of 196 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 - K043479

510(k) Number K043479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2004
Decision Date June 30, 2005
Days to Decision 196 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
74d slower than avg
Panel avg: 122d · This submission: 196d
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 K043479.
MODIFICATION TO: VERTE-STACK SPINAL SYSTEM
K052261 · Medtronic Sofamor Danek USA, Inc. · Oct 2005
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT
K051978 · Implex Corp. · Sep 2005
SEMIAL SPINAL IMPLANT
K051659 · Signus Medizintechnik GmbH · Jul 2005
OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI)
K043349 · 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