Cleared Traditional

K160916 - CoRoent Ti-C System

K160916 is the FDA 510(k) clearance for CoRoent Ti-C System by Nu Vasive, Incorporated. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K160916 · Nu Vasive, Incorporated · Orthopedic device
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Jun 2016
Decision
88d
Days
Class 2
Risk

K160916 is an FDA 510(k) clearance for the CoRoent® Ti-C System. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on June 28, 2016 after a review of 88 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 Nu Vasive, Incorporated devices

Submission Details

510(k) Number K160916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2016
Decision Date June 28, 2016
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

All 609
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K160916.
Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device
K160906 · Spineology, Inc. · Jul 2016
MLX™ - Medial Lateral Expandable Lumbar Interbody System
K153105 · Nu Vasive, Incorporated · Jul 2016
AccuLIF TL and PL Cage
K160715 · Stryker Corporation · Jul 2016
Lucent Intervertebral Body Fusion Device
K152011 · Spinal Elements, Inc. · Jun 2016
Genesys Spine Apache Interbody Fusion System
K153123 · Genesys Spine · Apr 2016
Leva Spacer System
K153222 · Spine Wave, Inc. · Apr 2016