Cleared Traditional

K151064 - Solitaire-C Cervical Spacer System

K151064 is an FDA 510(k) clearance for Solitaire-C Cervical Spacer System, manufactured by Biomet Spine. The device is a Class 2 Orthopedic device with product code OVE cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K151064 · Biomet Spine · Orthopedic device
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Aug 2015
Decision
114d
Days
Class 2
Risk

K151064 is an FDA 510(k) clearance for the Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenrid.... Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Biomet Spine (Broomfield, US). The FDA issued a Cleared decision on August 12, 2015 after a review of 114 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 Biomet Spine devices

FDA 510(k) Submission Details - K151064

510(k) Number K151064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2015
Decision Date August 12, 2015
Days to Decision 114 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
8d faster than avg
Panel avg: 122d · This submission: 114d
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 131
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K151064.
TOMCAT Cervical Spinal System
K152515 · Choicespine, LP · Dec 2015
ROI-C Titanium-Coated Implant System
K151934 · Ldr Spine USA · Dec 2015
LDR Spine ROI-C Cervical Cage System
K150765 · Ldr Spine USA · Sep 2015
A-CIFT SoloFuse
K151198 · Spinefrontier, Inc. · Jul 2015
SCARLET® AC-T Secured Anterior Cervical Cage
K143214 · Spineart · Feb 2015
DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM
K141599 · Medtronic Sofamor Danek USA, Inc. · Jan 2015