Cleared Traditional

K162694 - Ayers Rock Cervical interbody fusion system

K162694 is an FDA 510(k) clearance for Ayers Rock Cervical interbody fusion system, manufactured by Spineway. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K162694 · Spineway · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
107d
Days
Class 2
Risk

K162694 is an FDA 510(k) clearance for the Ayers Rock Cervical interbody fusion system. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Spineway (Ecully, FR). The FDA issued a Cleared decision on January 12, 2017 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. 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.

View all Spineway devices

FDA 510(k) Submission Details - K162694

510(k) Number K162694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2016
Decision Date January 12, 2017
Days to Decision 107 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 122d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODP Device Classification - Class 2, Special Controls

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 243
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K162694.
SeaSpine Cambria System
K171046 · SeaSpine Orthopedics Corporation · Jul 2017
Foundation 3D Interbody
K162496 · Corelink, LLC · May 2017
NuVasive CoRoent Small Interbody System
K163491 · Nu Vasive, Incorporated · Mar 2017
The Small PLATEAU (PLATEAU-C) Spacer System
K161127 · Life Spine, Inc. · Dec 2016
ShurFit CpTi-HA ACIF Interbody Fusion System
K161809 · Precision Spine, Inc. · Dec 2016
NuVasive CoRoent Small Ti-C System
K162138 · Nu Vasive, Incorporated · Oct 2016