Cleared Special

K170953 - Tomcat Cervical Spinal System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K170953 · Choicespine, LP · Orthopedic device
Apr 2017
Decision
21d
Days
Class 2
Risk

K170953 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 April 21, 2017 after a review of 21 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.

Submission Details

510(k) Number K170953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2017
Decision Date April 21, 2017
Days to Decision 21 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 116d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 22
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K170953.
E3D™-C Interbody System
K260038 · Evolution Spine · Feb 2026
HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)
K253876 · Globus Medical, Inc. · Dec 2025
Cervical Spine Truss System - Stand Alone (CSTS-SA)
K253200 · 4Web Medical, Inc. · Dec 2025
Endeavor™ Stand-Alone Cervical IBF System
K250076 · Innovasis · Sep 2025
SABER-C System
K250540 · Elevation Spine · Aug 2025
Stabilis SA Cervical Stand-Alone System (Various PNs)
K251735 · Acuity Surgical Devices, LLC · Jul 2025