Cleared Special

K121852 - SYNTHES ZERO-P VARIABLE ANGLE (VA)

K121852 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 Special 510(k) pathway after a 30-day FDA review.

K121852 · Synthes Spine Co.Lp · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
30d
Days
Class 2
Risk

K121852 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 July 25, 2012 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K121852

510(k) Number K121852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2012
Decision Date July 25, 2012
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 168
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K121852.
PRO-LINK CERVICAL SPACER SYSTEM
K121151 · Life Spine, Inc. · Nov 2012
INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE
K122008 · Incite Innovation, LLC · Nov 2012
STALIF C
K120819 · Centinel Spine, Inc. · Aug 2012
SOLITAIRE-C CERVICAL SPACER SYSTEM
K113796 · Ebi, LLC · Apr 2012
PEEK PREVAIL CERVICAL INTERBODY DEVICE
K113252 · Medtronic Sofamor Danek · Jan 2012
LANX CERVICAL SA
K112388 · Lanx, Inc. · Dec 2011