Cleared Special

K092540 - C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER

K092540 is an FDA 510(k) clearance for C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, manufactured by Rsb Spine, LLC. The device is a Class 2 Orthopedic device with product code ODP cleared through the Special 510(k) pathway after a 161-day FDA review.

K092540 · Rsb Spine, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
161d
Days
Class 2
Risk

K092540 is an FDA 510(k) clearance for the C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY.... Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Rsb Spine, LLC (Chesterland, US). The FDA issued a Cleared decision on January 27, 2010 after a review of 161 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.

FDA 510(k) Submission Details - K092540

510(k) Number K092540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2009
Decision Date January 27, 2010
Days to Decision 161 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
39d slower than avg
Panel avg: 122d · This submission: 161d
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 352
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K092540.
ALEUTIAN IBF SYSTEM
K101302 · K2m, Inc. · Jul 2010
CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE
K100214 · Medtronic Sofamor Danek · Jun 2010
IMPIX MANTA CERVICAL INTERBODY DEVICE
K100484 · Medicrea · Mar 2010
PATHWAY IVB/VBR
K092904 · Custom Spine, Inc. · Dec 2009
CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER
K091531 · Choice Spine, Llp · Nov 2009
ORIO-C CERVICAL, ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF INTERVEDRTEBRAL BODY FUSION CAGES
K090887 · SpineCraft · Oct 2009
K092540 · C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER
Download PDF FDA Summary Rsb Spine, LLC