Cleared Special

K072132 - LDR SPINE ROI-T SYSTEM

K072132 is an FDA 510(k) clearance for LDR SPINE ROI-T SYSTEM, manufactured by Ldr Spine USA. The device is a Class 2 Orthopedic device with product code MQP cleared through the Special 510(k) pathway after a 28-day FDA review.

K072132 · Ldr Spine USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
28d
Days
Class 2
Risk

K072132 is an FDA 510(k) clearance for the LDR SPINE ROI-T SYSTEM. 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 August 30, 2007 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ldr Spine USA devices

FDA 510(k) Submission Details - K072132

510(k) Number K072132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2007
Decision Date August 30, 2007
Days to Decision 28 days
Submission Type Special
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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K072132.
ZUMA
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VU E*POD VERTEBRAL BODY REPLACEMENT
K071031 · Theken Spine, LLC · Jul 2007
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K070786 · Theken Spine, LLC · Jun 2007