Cleared Special

K152515 - TOMCAT Cervical Spinal System

K152515 is an FDA 510(k) clearance for TOMCAT Cervical Spinal System, manufactured by Choicespine, LP. The device is a Class 2 Orthopedic device with product code OVE cleared through the Special 510(k) pathway after a 107-day FDA review.

K152515 · Choicespine, LP · Orthopedic device
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Dec 2015
Decision
107d
Days
Class 2
Risk

K152515 is an FDA 510(k) clearance for the TOMCAT Cervical Spinal System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Choicespine, LP (Knoxville, US). The FDA issued a Cleared decision on December 18, 2015 after a review of 107 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 Choicespine, LP devices

FDA 510(k) Submission Details - K152515

510(k) Number K152515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2015
Decision Date December 18, 2015
Days to Decision 107 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
15d faster than avg
Panel avg: 122d · This submission: 107d
Pathway characteristics
Modification to existing cleared device.

OVE Device Classification - Class 2, Special Controls

Product Code OVE Intervertebral Fusion Device With Integrated Fixation, 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 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 - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 153
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K152515.
ArcadiusXP C Spinal System
K153629 · Aesculap Implant Systems, Inc. · May 2016
COALITION Spacers
K151939 · Globus Medical, Inc. · Jan 2016
Amendia Stand-Alone Cervical System
K152972 · Amendia, Inc. · Jan 2016
ROI-C Titanium-Coated Implant System
K151934 · Ldr Spine USA · Dec 2015
LDR Spine ROI-C Cervical Cage System
K150765 · Ldr Spine USA · Sep 2015
Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System
K151064 · Biomet Spine · Aug 2015