The ZEVO™ Anterior Cervical Plate System is intended for anterior interbody screw fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis, 5) pseudoathrosis, and/or 6) failed previous fusions.

Device Description

The ZEVO™ Anterior Cervical Plate System consists of temporary implants (plates and bone screws) intended for anterior screw fixation of the cervical spine during the development of a cervical spinal fusion. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The device is intended for the anterior screw fixation from C2- T1 in the cervical spine. The ZEVO™ Anterior Cervical Plate System implants are available in a broad range of size offerings, and are supplied in both sterile and non-sterile form. The implant components are made from titanium alloy, with plates having subcomponents manufacturing from nitinol (NiTi).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ZEVO™ Anterior Cervical Plate System. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness through extensive clinical trials with acceptance criteria based on patient outcomes or AI performance metrics.

Therefore, the information requested (acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable to this document.

The document describes non-clinical tests performed to demonstrate substantial equivalence. Here's a breakdown of that information:

1. A table of acceptance criteria and the reported device performance:

Test Method	Acceptance Criteria	Reported Device Performance
ASTM F1717-13 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model"	Pre-determined acceptance criteria for spinal implant constructs. (Specific criteria not detailed in this document but would be defined within the standard or by the manufacturer based on predicate device performance.)	The subject device met the pre-determined acceptance criteria for all tests.
ASTM F2129-08 "Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices"	Pre-determined acceptance criteria for corrosion susceptibility. (Specific criteria not detailed in this document but would be defined within the standard or by the manufacturer.)	The subject device met the pre-determined acceptance criteria for all tests.

Reasoning for "Not Applicable" for other points:

Sample sized used for the test set and the data provenance: This device is a physical implant. "Test set" in this context refers to the number of physical samples subjected to mechanical and corrosion testing, not a dataset of patient images or clinical data. The document does not specify the number of samples used for these non-clinical tests. Data provenance (country of origin, retrospective/prospective) is not relevant for in-vitro mechanical and corrosion testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: "Experts" and "ground truth" (in the medical AI sense) are not applicable here. The ground truth for mechanical and corrosion tests is established by the specifications of the ASTM standards and the physical properties of the materials and device design.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical engineering tests. Test results are objective measurements based on established standards.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is a physical implant, not a diagnostic or AI-driven device that assists human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. For the non-clinical tests described, the "ground truth" is defined by the physical test conditions, material properties, and the established ASTM standards.
The sample size for the training set: Not applicable. There is no concept of a "training set" for a physical medical device undergoing mechanical and corrosion testing.
How the ground truth for the training set was established: Not applicable.

In summary, this document pertains to the regulatory clearance of a physical medical device based on substantial equivalence demonstrated through non-clinical laboratory testing, not a clinical study or AI performance evaluation.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 4, 2014

Medtronic Sofamor Danek USA, Incorporated Ms. Kristi Frisch Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K141632

Trade/Device Name: ZEVO™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 16, 2014 Received: October 17, 2014

Dear Ms. Frisch:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K141632

Device Name ZEVOTM Anterior Cervical Plate System

Indications for Use (Describe)

The ZEVO™ Anterior Cervical Plate System is interbody screw fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) defined as kyphosis, lordosis, or scoliosis, 5) pseudoathrosis, and/or 6) failed previous fusions.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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ZEVO™ Anterior Cervical Plate System 510(k) Summary December, 2014

I.	Company:	Medtronic Sofamor Danek USA, Inc.1800 Pyramid PlaceMemphis, TN 38132(901) 396-3133
II.	Contact:	Kristi FrischSenior Regulatory Affairs Specialist
III.	Proprietary Trade Name:	ZEVO™ Anterior Cervical Plate System
IV.	Common Name:	Spinal Intervertebral Body FixationAppliance
V.	Classification Name:	21 CFR 888.3060 - Spinal IntervertebralBody Fixation Orthosis
	Classification:	Class II
	Product Codes:	KWO

VI. Product Description:

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The ZEVO™ Anterior Cervical Plate System implants are available in a broad range of size offerings, and are supplied in both sterile and non-sterile form. The implant components are made from titanium alloy, with plates having subcomponents manufacturing from nitinol (NiTi).

Indications for Use: VII.

Summary of Technological Characteristics VIII.

The subject ZEVO™ Anterior Cervical Plate System components have the same fundamental scientific technology as the predicate Cervical Spine Locking Plate (CSLP), ATLANTIS® Anterior Cervical System and ZEPHIR® Anterior Cervical System devices. The subject devices are manufactured from the same titanium alloy and nitinol material as the predicate ATLANTIS® devices. The predicate and subject devices are also anterior screw fixation devices where fixation is provided by bone screws inserted into the vertebral body of the cervical spine.

IX. Identification of Legally Marketed Predicate Devices Used to Claim Substantial Equivalence

The subject plate and bone screws are substantially equivalent to the predicates:

Primary Predicate:

Anterior Cervical Spine Locking Plate (CSLP) System, (K030866, SE . 04/18/2003) [SYNTHES® Spine]

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Additional predicates:

ATLANTIS® Anterior Cervical Plate System (K130640, SE . 06/04/2013; K081038, SE 08/15/2008) [Medtronic]
ZEPHIR® Anterior Cervical System (K030327, SE 02/26/2003; . K994239, SE 06/19/2000) [Medtronic]

To the best of Medtronic's knowledge, none of the predicates listed here have been subject to a design-related recall.

Brief Discussion of the Non-Clinical Tests Submitted X.

The subject ZEVO™ Anterior Cervical Plate devices were tested in accordance to ASTM F1717-13 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model" and ASTM F2129-08 "Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices." The subject device met the pre-determined acceptance criteria for all tests. The test results are provided to demonstrate that the subject devices are substantially equivalent to the predicate devices.

Conclusions Drawn from the Non-Clinical Tests XI.

Based on the non-clinical test results and additional supporting documentation provided in this pre-market notification, the subject devices demonstrated substantial equivalence to the listed predicate devices.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.