Cleared Traditional

K152972 - Amendia Stand-Alone Cervical System

K152972 is an FDA 510(k) clearance for Amendia Stand-Alone Cervical System, manufactured by Amendia, Inc.. The device is a Class 2 Orthopedic device with product code OVE cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K152972 · Amendia, Inc. · Orthopedic device
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Jan 2016
Decision
98d
Days
Class 2
Risk

K152972 is an FDA 510(k) clearance for the Amendia Stand-Alone Cervical System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Amendia, Inc. (Marietta, US). The FDA issued a Cleared decision on January 14, 2016 after a review of 98 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 Amendia, Inc. devices

FDA 510(k) Submission Details - K152972

510(k) Number K152972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2015
Decision Date January 14, 2016
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
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 162
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K152972.
Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System
K153250 · Renovis Surgical Technologies · Mar 2016
COALITION Spacers
K151939 · Globus Medical, Inc. · Jan 2016
Unison-C Anterior Cervical Fixation System
K152793 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Jan 2016
TOMCAT Cervical Spinal System
K152515 · Choicespine, LP · Dec 2015
Endoskeleton(r) TCS System
K153122 · Titan Spine, LLC · Dec 2015
ROI-C Titanium-Coated Implant System
K151934 · Ldr Spine USA · Dec 2015