Cleared Special

K113559 - LDR SPINE CERVICAL INTERBODY FUSION SYS...

K113559 is an FDA 510(k) clearance for LDR SPINE CERVICAL INTERBODY FUSION SYS..., manufactured by Ldr Spine USA, Inc.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Special 510(k) pathway after a 28-day FDA review.

K113559 · Ldr Spine USA, Inc. · Orthopedic device
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Dec 2011
Decision
28d
Days
Class 2
Risk

K113559 is an FDA 510(k) clearance for the LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Ldr Spine USA, Inc. (Austin, US). The FDA issued a Cleared decision on December 29, 2011 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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. 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, Inc. devices

FDA 510(k) Submission Details - K113559

510(k) Number K113559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2011
Decision Date December 29, 2011
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

ODP Device Classification - Class 2, Special Controls

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical 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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 251
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K113559.
RELIANCE CERVICAL IBF SYSTEM
K120396 · Reliance Medical Systems, LLC · May 2012
DEPUY PULSE CERVICAL CAGE SYSTEM
K120517 · Medos International SARL · Apr 2012
ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
K113518 · Spinefrontier, Inc. · Feb 2012
MECTA-C
K112862 · Medacta International · Dec 2011
TRABECULAR METAL (TM) FUSION DEVICE
K111119 · Zimmer Spine, Inc. · Nov 2011
CALIX PC SPINAL IMPLANT SYSTEM
K112036 · X-Spine Systems, Inc. · Nov 2011