Cleared Traditional

K162531 - STERISPINE CC

K162531 is an FDA 510(k) clearance for STERISPINE CC, manufactured by Safe Orthopaedics. The device is a Class 2 Orthopedic device with product code OVE cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K162531 · Safe Orthopaedics · Orthopedic device
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Dec 2016
Decision
111d
Days
Class 2
Risk

K162531 is an FDA 510(k) clearance for the STERISPINE CC. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Safe Orthopaedics (Eragny Sur Oise, FR). The FDA issued a Cleared decision on December 29, 2016 after a review of 111 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 Safe Orthopaedics devices

FDA 510(k) Submission Details - K162531

510(k) Number K162531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2016
Decision Date December 29, 2016
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
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 Peers - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 154
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K162531.
Tomcat Cervical Spinal System
K170953 · Choicespine, LP · Apr 2017
CAVUX CervicalCage-L SA System
K163474 · Providence Medical Technology, Inc. · Mar 2017
Spine Wave Anterior Cervical Spine System
K162760 · Spine Wave, Inc. · Feb 2017
Irix-C Cervical Integrated Fusion System
K162944 · X-Spine Systems, Inc. · Nov 2016
Xenco Medical Cervical Interbody System
K160313 · Xenco Medical, LLC · Oct 2016
NuVasive® CoRoent® Small Interlock™ System
K161442 · Nu Vasive, Incorporated · Sep 2016