Cleared Traditional

K152099 - Genesys Spine Apache Anchored Cervical ...

K152099 is the FDA 510(k) clearance for Genesys Spine Apache Anchored Cervical ... by Genesys Spine. It is a Class 2 Orthopedic device (product code OVE) cleared through the Traditional 510(k) pathway after a 366-day FDA review.

K152099 · Genesys Spine · Orthopedic device
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Jul 2016
Decision
366d
Days
Class 2
Risk

K152099 is an FDA 510(k) clearance for the Genesys Spine Apache® Anchored Cervical Interbody Fusion System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Genesys Spine (Austin, US). The FDA issued a Cleared decision on July 28, 2016 after a review of 366 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Genesys Spine devices

Submission Details

510(k) Number K152099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2015
Decision Date July 28, 2016
Days to Decision 366 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
244d slower than avg
Panel avg: 122d · This submission: 366d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 115
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K152099.
SeaSpine Shoreline ACS - Anterior Cervical Standalone System
K161081 · SeaSpine Orthopedics Corporation · Sep 2016
Pro-Link® Stand-Alone Cervical Spacer System
K160066 · Life Spine, Inc. · Sep 2016
Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System
K153352 · Spinal Elements, Inc. · Aug 2016
Cervical Stand Alone System
K161280 · Orthofix, Inc. · Jun 2016
COALITION Spacers
K151939 · Globus Medical, Inc. · Jan 2016
SCARLET® AC-T Secured Anterior Cervical Cage
K143214 · Spineart · Feb 2015