Cleared Special

K080572 - LDR SPINE ROI-A IMPLANT

K080572 is an FDA 510(k) clearance for LDR SPINE ROI-A IMPLANT, 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 38-day FDA review.

K080572 · Ldr Spine USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
38d
Days
Class 2
Risk

K080572 is an FDA 510(k) clearance for the LDR SPINE ROI-A IMPLANT. 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 April 7, 2008 after a review of 38 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 - K080572

510(k) Number K080572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2008
Decision Date April 07, 2008
Days to Decision 38 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
84d faster than avg
Panel avg: 122d · This submission: 38d
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 K080572.
NOVEL SPINAL SPACER SYSTEM
K080699 · Alphatec Spine, Inc. · May 2008
LDR SPINE ROI-T IMPLANT
K080569 · Ldr Spine USA · May 2008
X-MESH EXPANDABLE CAGE SYSTEM
K080568 · Depuy Spine, Inc. · May 2008
KIMBA MINI
K080349 · Signus Medizintechnik GmbH · Mar 2008
BENGAL STACKABLE CAGE SYSTEM
K073649 · Depuy Spine, Inc. · Jan 2008
ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01
K080024 · K2m, Inc. · Jan 2008