Cleared Special

K090507 - MODIFICATION TO LDR SPINE ROI INTERBODY...

Also marketed or referenced as:
ROI-A IMPLANT SYSTEM

K090507 is an FDA 510(k) clearance for MODIFICATION TO LDR SPINE ROI INTERBODY..., manufactured by Ldr Spine USA. The device is a Class 2 Orthopedic device with product code MAX cleared through the Special 510(k) pathway after a 120-day FDA review.

K090507 · Ldr Spine USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
120d
Days
Class 2
Risk

K090507 is an FDA 510(k) clearance for the MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Ldr Spine USA (Austin, US). The FDA issued a Cleared decision on June 25, 2009 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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. Standard predicate reliance. 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 - K090507

510(k) Number K090507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2009
Decision Date June 25, 2009
Days to Decision 120 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
2d faster than avg
Panel avg: 122d · This submission: 120d
Pathway characteristics
Modification to existing cleared device.

MAX Device Classification - Class 2, Special Controls

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 643
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K090507.
SPINAL USA INTERBODY CAGES
K092193 · Spinal USA · Sep 2009
DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031
K091638 · Spinefrontier, Inc. · Sep 2009
IBEX SPINAL SYSTEM
K091381 · Ebi, L.P. · Aug 2009
DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS
K081917 · Depuy Spine, Inc. · May 2009
GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM
K090425 · Alphatec Spine, Inc. · May 2009
DEPUY SPINE LATERAL SYSTEM
K090899 · Depuy Spine, Inc. · May 2009