Cleared Special

K093762 - SYNTHES ZERO-P

K093762 is the FDA 510(k) clearance for SYNTHES ZERO-P by Synthes Spine. It is a Class 2 Orthopedic device (product code OVE) cleared through the Special 510(k) pathway after a 378-day FDA review.

K093762 · Synthes Spine · Orthopedic device
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Dec 2010
Decision
378d
Days
Class 2
Risk

K093762 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 (West Chester, US). The FDA issued a Cleared decision on December 20, 2010 after a review of 378 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. 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. Elevated predicate reliance profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Synthes Spine devices

Submission Details

510(k) Number K093762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2009
Decision Date December 20, 2010
Days to Decision 378 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
256d slower than avg
Panel avg: 122d · This submission: 378d
Pathway characteristics
Modification to existing cleared device.

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 K093762.
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
PEEK PREVAIL CERVICAL INTERBODY DEVICE
K094042 · Medtronic Sofamor Danek · Jun 2010
COALITION SPACER
K083389 · Globus Medical, Inc. · Mar 2009
PEEK PREVAIL CERVICAL INTERBODY DEVICE
K073285 · Medtronic Sofamor Danek USA, Inc. · May 2008