Cleared Traditional

K160324 - Cervical Interbody Fusion System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K160324 · Evolution Spine, LLC · Orthopedic device
May 2016
Decision
90d
Days
Class 2
Risk

K160324 is an FDA 510(k) clearance for the Cervical Interbody Fusion System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Evolution Spine, LLC (Dallas, US). The FDA issued a Cleared decision on May 5, 2016 after a review of 90 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K160324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2016
Decision Date May 05, 2016
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 116d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 38
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K160324.
Flex-Z™ Cervical Cage
K252432 · Spinepoint, LLC · Mar 2026
Hive™ Standalone Cervical System and Hive™ C Interbody System
K254105 · NanoHive Medical, LLC · Feb 2026
Curiteva Porous PEEK Cervical Interbody System
K252205 · Curiteva, Inc. · Jan 2026
Curiteva Porous PEEK Cervical Interbody Fusion System
K254061 · Curiteva, Inc. · Jan 2026
Cervical Interbody and VBR Fusion System
K252219 · Sync Surgical · Jan 2026
Advantage-C™ Ti3D Cervical Interbody Fusion Device
K252711 · Intelivation Technologies · Jan 2026