Cleared Traditional

K112068 - SYNTHES ZERO-P VARIABLE ANGLE (VA)

K112068 is an FDA 510(k) clearance for SYNTHES ZERO-P VARIABLE ANGLE (VA), manufactured by Synthes Spine Co.Lp. The device is a Class 2 Orthopedic device with product code OVE cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K112068 · Synthes Spine Co.Lp · Orthopedic device
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Nov 2011
Decision
110d
Days
Class 2
Risk

K112068 is an FDA 510(k) clearance for the SYNTHES ZERO-P VARIABLE ANGLE (VA). Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Synthes Spine Co.Lp (West Chester, US). The FDA issued a Cleared decision on November 7, 2011 after a review of 110 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 Synthes Spine Co.Lp devices

FDA 510(k) Submission Details - K112068

510(k) Number K112068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2011
Decision Date November 07, 2011
Days to Decision 110 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
12d faster than avg
Panel avg: 122d · This submission: 110d
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 134
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K112068.
PEEK PREVAIL CERVICAL INTERBODY DEVICE
K113252 · Medtronic Sofamor Danek · Jan 2012
LANX CERVICAL SA
K112388 · Lanx, Inc. · Dec 2011
SYNTHES ZERO-P
K112459 · Synthes Spine Co.Lp · Dec 2011
CHESAPEAKE (CERVICAL COMPONENTS)
K111439 · K2m, Inc. · Aug 2011
AVS ANCHOR-C CERVICAL CAGE SYSTEM
K102606 · Stryker Spine · Apr 2011
COROENT INTERLOCK SYSTEM
K102547 · Nuvasive, Inc. · Feb 2011