Cleared Special

K112459 - SYNTHES ZERO-P

K112459 is an FDA 510(k) clearance for SYNTHES ZERO-P, 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 108-day FDA review.

K112459 · Synthes Spine Co.Lp · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
108d
Days
Class 2
Risk

K112459 is an FDA 510(k) clearance for the SYNTHES ZERO-P. 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 December 12, 2011 after a review of 108 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. 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. Standard predicate reliance. 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 - K112459

510(k) Number K112459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2011
Decision Date December 12, 2011
Days to Decision 108 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
14d faster than avg
Panel avg: 122d · This submission: 108d
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 K112459.
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
RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM
K111272 · Rhausler, Inc. · Nov 2011
SYNTHES ZERO-P VARIABLE ANGLE (VA)
K112068 · Synthes Spine Co.Lp · Nov 2011
CHESAPEAKE (CERVICAL COMPONENTS)
K111439 · K2m, Inc. · Aug 2011