SYNTHES ZERO-P

K112459 · Synthes Spine Co.Lp · OVE · Dec 12, 2011 · Orthopedic

Device Facts

• Record ID: K112459
• Device Name: SYNTHES ZERO-P
• Applicant: Synthes Spine Co.Lp
• Product Code: OVE · Orthopedic
• Decision Date: Dec 12, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Zero-P is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Synthes Zero-P should be packed with autogenous bone graft and implanted via an anterior approach.

Device Story

Synthes Zero-P is a stand-alone anterior cervical interbody fusion device. It consists of a PEEK Optima spacer with a radiopaque marker and a titanium alloy anterior plate with screws. The device is implanted via an anterior approach; the spacer interior is packed with autogenous bone graft. Screws are inserted through the plate into adjacent vertebral bodies and secured using a tapered-thread locking mechanism. Used in clinical settings by surgeons to treat degenerative disc disease. The device provides structural support and fixation to facilitate intervertebral fusion, potentially reducing discogenic pain and radicular symptoms.

Clinical Evidence

Bench testing only. Static and dynamic compression, shear, and torsion testing were performed in accordance with ASTM F2077 to demonstrate safety and effectiveness comparable to predicate devices.

Technological Characteristics

Materials: PEEK Optima (ASTM F2026-02), radiopaque marker (ASTM F136-2a), titanium alloy (ASTM F1295-01). Design: Intervertebral body fusion device with integrated anterior plate and tapered-thread screw locking mechanism. Available in various heights and geometries.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) and radicular symptoms at one level from C2-T1, following six weeks of failed non-operative treatment.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Synthes Zero-P System (K072981)
• Synthes Zero-P [sterile screws (K093762)]
• Medtronic PEEK Prevail (K073285)

Submission Summary (Full Text)

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® **SYNTHES**®
Spine

510(K) Summary

K112459 Page 1 of 2

______________________________________________________________________________________________________________________________________________________________________________

DEC. 1 2 2011

| | Synthes Zero-P “Large Footprint“ (K112459) |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Firm: | Synthes Spine<br>1302 Wrights Lane East<br>West Chester, PA 19380 |
| 510(k) Contact: | Stacey Bonnell<br>Senior Regulatory Affairs Specialist, Synthes Spine<br>Telephone: [phone]<br>Facsimile: 610-719-5102<br>Email: [e-mail] |
| Date Prepared: | November 25, 2011 |
| Trade Name: | Synthes Zero-P |
| Common Name: | Intervertebral fusion device |
| Classification: | 21 CFR 888.3080 Intervertebral fusion device<br>Class II (special controls)<br>Orthopaedic and Rehabilitation Devices Panel<br>Product Code OVE (Intervertebral Fusion Device w/ Integrated Fixation,<br>Cervical) |
| Predicate Devices: | Synthes Zero-P System (K072981);<br>Synthes Zero-P [sterile screws (K093762)];<br>Medtronic PEEK Prevail (K073285). |
| Device Description: | The purpose of this submission is to introduce an additional, larger<br>footprint Zero-P spacer, as well as minor modifications to<br>approved labeling.<br><br>The Synthes Zero-P is a radiolucent and radiopaque cervical<br>intervertebral body fusion device. The Zero-P spacer is composed<br>of PEEK Optima (ASTM F2026-02) with a radiopaque marker<br>(ASTM F136-2a), and a titanium alloy anterior plate and screws<br>(ASTM F F1295-01). The screws are inserted through the plate<br>into the adjacent vertebral bodies and lock securely to the plate<br>using a tapered-thread locking mechanism.<br><br>The Synthes Zero-P is available as assembled components in<br>various heights and geometries to suit individual pathology and<br>anatomical conditions. |

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| . SYV<br>(<br>20 - 1 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -<br>11 | |
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| *<br>pine | |

| Intended Use /<br>Indications for Use: | The Synthes Zero-P is a stand-alone anterior cervical interbody<br>fusion device indicated for use in skeletally mature patients with<br>degenerative disc disease (DDD) with accompanying radicular<br>symptoms at one level from C2-T1. DDD is defined as discogenic<br>pain with degeneration of the disc confirmed by history and<br>radiographic studies. These patients should have had six weeks of<br>non-operative treatment. The interior of the spacer component of<br>the Synthes Zero-P should be packed with autogenous bone graft<br>and implanted via an anterior approach. |
|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of the<br>technological<br>characteristics of<br>the device to the<br>predicate device: | The modifications herein presented to Synthes Zero-P device are<br>substantially equivalent to identified predicates, Synthes Zero-P<br>System (K072981); Synthes Zero-P [sterile screws (K093762)];<br>Medtronic PEEK Prevail (K073285) in indications, fundamental<br>scientific technology, material, mechanical performance, surgical<br>technique, screw fixation and design. |
| Performance Data<br>(Nonclinical and/or<br>Clinical) | Synthes performed static and dynamic compression shear and<br>torsion testing in accordance with ASTM F2077. The enclosed<br>information demonstrates the subject device is as safe, effective<br>and performs as well as the predicate. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract eagle or bird-like figure, with three curved lines representing the wings or body.

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

Synthes Spine Co., L.P. % Ms. Stacey Bonnell Senior Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380

DEC 1 2 2011

Re: K112459

Trade/Device Name: Synthes Zero-P Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: November 23, 2011 Received: November 25, 2011

Dear Ms. Bonnell:

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

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## Page 2 - Ms. Stacey Bonnell

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/gefault.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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for SYNTHES Spine. The logo consists of a circular symbol with an acorn inside, followed by the word "SYNTHES" in bold, sans-serif font with a trademark symbol. Below the word "SYNTHES" is the word "Spine" in a smaller, italicized font.

## Indications for Use Statement 5

| 510(k) Number:<br>(if known) | K 112459 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes Zero-P |
| Indications for Use: | The Synthes Zero-P is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Synthes Zero-P should be packed with autogenous bone graft and implanted via an anterior approach. |

Prescription Use X (21 CFR 801 Subpart D) AND / OR

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

and the commend of the comments of the comments of the comments of the comments of the comments of the contribution of the first of the first of the first of the first of the

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------|--------------------------------------------------------|
| | (Division/Sign-C |
| | Division of Surg , Orthopedic, |
| | and Restorative Devices |
| Special 510(k) | 510(k) Number |
| | K112459 |
| Synthes Zero-P Large Footprint | |