Cleared Traditional

K153122 - Endoskeleton(r) TCS System

K153122 is an FDA 510(k) clearance for Endoskeleton(r) TCS System, manufactured by Titan Spine, LLC. The device is a Class 2 Orthopedic device with product code OVE cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K153122 · Titan Spine, LLC · Orthopedic device
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Dec 2015
Decision
46d
Days
Class 2
Risk

K153122 is an FDA 510(k) clearance for the Endoskeleton(r) TCS System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Titan Spine, LLC (Mequon, US). The FDA issued a Cleared decision on December 14, 2015 after a review of 46 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Titan Spine, LLC devices

FDA 510(k) Submission Details - K153122

510(k) Number K153122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2015
Decision Date December 14, 2015
Days to Decision 46 days
Submission Type Traditional
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
76d faster than avg
Panel avg: 122d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Memphis Regulatory Consulting, LLC
Christine Scifert

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 162
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K153122.
Unison-C Anterior Cervical Fixation System
K152793 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Jan 2016
Amendia Stand-Alone Cervical System
K152972 · Amendia, Inc. · Jan 2016
TOMCAT Cervical Spinal System
K152515 · Choicespine, LP · Dec 2015
ROI-C Titanium-Coated Implant System
K151934 · Ldr Spine USA · Dec 2015
Endoskeleton TCS Interbody Fusion Device
K151596 · Titan Spine, LLC · Oct 2015
LDR Spine ROI-C Cervical Cage System
K150765 · Ldr Spine USA · Sep 2015