Cleared Special

K110327 - LDR SPINE ROI-A INTERBODY FUSION SYSTEM

K110327 is an FDA 510(k) clearance for LDR SPINE ROI-A INTERBODY FUSION SYSTEM, manufactured by Ldr Spine USA. The device is a Class 2 Orthopedic device with product code OVD cleared through the Special 510(k) pathway after a 239-day FDA review.

K110327 · Ldr Spine USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
239d
Days
Class 2
Risk

K110327 is an FDA 510(k) clearance for the LDR SPINE ROI-A INTERBODY FUSION SYSTEM. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Ldr Spine USA (Austin, US). The FDA issued a Cleared decision on September 30, 2011 after a review of 239 days - an extended review cycle.

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 - K110327

510(k) Number K110327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2011
Decision Date September 30, 2011
Days to Decision 239 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
117d slower than avg
Panel avg: 122d · This submission: 239d
Pathway characteristics
Modification to existing cleared device.

OVD Device Classification - Class 2, Special Controls

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 158
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K110327.
CHESAPEAKE SPINAL SYSTEM
K120031 · K2m, Inc. · Mar 2012
NUVASIVE COROENT NO-PROFILE SYSTEM
K112561 · Nuvasive, Inc. · Mar 2012
SOVEREIGN SPINAL SYSTEM
K110063 · Medtronic Sofamor Danek, Inc. · Oct 2011
INTERCONTINENTAL PLATE-SPACER
K103382 · Globus Medical, Inc. · May 2011
VAULT ALIF SYSTEM
K103369 · Spinal USA · Apr 2011
SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM
K102402 · Alphatec Spine, Inc. · Mar 2011