SYNTHES ZERO-P VARIABLE ANGLE (VA)

K112068 · Synthes Spine Co.Lp · OVE · Nov 7, 2011 · Orthopedic

Device Facts

• Record ID: K112068
• Device Name: SYNTHES ZERO-P VARIABLE ANGLE (VA)
• Applicant: Synthes Spine Co.Lp
• Product Code: OVE · Orthopedic
• Decision Date: Nov 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Zero-P VA 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 VA should be packed with autogenous bone graft and implanted via an anterior approach.

Device Story

Synthes Zero-P VA is a stand-alone anterior cervical interbody fusion device; consists of PEEK-Optima LT-1 spacer with titanium alloy (Ti-6Al-4V ELI) radiopaque marker; preassembled with titanium alloy (Ti-6Al-7Nb) interbody plate; includes lock-catch mechanism with TAV lock-screw, catch, and Elgiloy spring; implanted anteriorly using two 3.7mm diameter screws. Used by surgeons in clinical settings to treat degenerative disc disease; spacer packed with autogenous bone graft to facilitate fusion. Provides mechanical stability to vertebral bodies during fusion process; allows intra-operative radiographic assessment of implant position via marker.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing including static and dynamic axial compression, compression shear, and torsion, as well as subsidence testing per ASTM F2077-03 and ASTM F2267-04.

Technological Characteristics

Spacer: PEEK-Optima LT-1 (ASTM F2026). Radiopaque marker: Titanium alloy (Ti-6Al-4V ELI; ASTM F136-2a). Interbody plate/screws: Titanium alloy (Ti-6Al-7Nb; ASTM F1295). Lock-catch spring: Elgiloy (ASTM F1058). Mechanical fixation via integrated screw-plate system.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) and radicular symptoms at one level from C2-T1, confirmed by history and radiography, 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 device (K072981)
• Sulzer BAK™/Cervical IBF (P980048)
• Synthes Vectra (K050451)
• Synthes Vectra-T (K051665)
• Globus Coalition (K083389)
• Medtronic PEEK Prevail (K073285)
• RSB InterPlate C-P (K092070)

Submission Summary (Full Text)

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| Synthes Zero-P VA (K112068)<br>510(k) Summary | |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 7, 2011 |
| Trade Name: | Synthes Zero-P VA |
| Classification: | 21 CFR 888.3080 - Intervertebral Body Fusion Device<br>Class II (special controls)<br>Orthopaedic and Rehabilitation Devices Panel (87)<br>Product Code OVE (Intervertebral Fusion Device w/ Integrated Fixation,<br>Cervical) |
| Predicates: | Synthes Zero-P device (K072981);<br>Sulzer BAK™/Cervical IBF (P980048);<br>Synthes Vectra (K050451);<br>Synthes Vectra-T (K051665);<br>Globus Coalition (K083389)<br>Medtronic PEEK Prevail (K073285)<br>RSB InterPlate C-P (K092070) |
| Device Description: | The Synthes Zero-P VA is a radiolucent and radiopaque<br>intervertebral body fusion device. The Synthes Zero-P VA is<br>composed of a spacer made from Invibio® PEEK-Optima® LT-1<br>(ASTM F2026) with a single posterior titanium alloy (Ti-6Al-4V<br>ELI; TAV; ASTM F136-2a) radiopaque marker. The marker allows<br>accurate intra-operative radiographic assessment of the position of<br>the implant. The spacer component is preassembled with a mating<br>titanium alloy (Ti-6Al-7Nb; TAN; ASTM F1295) interbody plate.<br>The device is implanted anteriorly by inserting two screws (TAN)<br>through the plate, one screw per vertebral body. The interbody plate<br>incorporates a lock-catch mechanism in each screw hole comprised<br>of a TAV lock-screw and catch, as well as an Elgiloy (ASTM<br>F1058) spring. The screws offered with the Zero-P VA system are<br>3.7mm in diameter. |
| Intended Use/ | The Synthes Zero-P VA is a stand-alone anterior cervical interbody fusion |

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| SYNTHES® |
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| Spine |

| Indications for Use: | device indicated for use in skeletally mature patients with degenerative<br>disc disease (DDD) with accompanying radicular symptoms at one level<br>from C2-T1. DDD is defined as discogenic pain with degeneration of the<br>disc confirmed by history and radiographic studies. These patients should<br>have had six weeks of non-operative treatment. The interior of the spacer<br>component of the Synthes Zero-P VA should be packed with autogenous<br>bone graft and implanted via an anterior approach. |
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| Comparison of the<br>device to predicate<br>device(s): | The Synthes Zero-P VA is substantially equivalent to the established<br>predicates in design, function, material and intended use. |
| Performance Date<br>(Nonclinical and/or<br>Clinical): | Non-Clinical Performance and Conclusions:<br>Synthes conducted the following bench testing (as recommended within<br>FDA Guidance and in accordance with ASTM F2077-03 and ASTM<br>F2267-04): Static Axial Compression; Dynamic Axial Compression; Static<br>Compression Shear; Dynamic Compression Shear; Static Torsion;<br>Dynamic Torsion; and Subsidence. The conclusions drawn from testing<br>demonstrate that the Synthes Zero-P VA device is substantially equivalent<br>in performance to the following predicate devices: Synthes Zero-P device<br>(K072981); Sulzer BAK™/Cervical IBF (P980048); and Medtronic PEEK<br>Prevail (K073285).<br>Clinical Performance and Conclusions<br>Clinical data and conclusions were not needed for this device. |

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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 features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

NOV - 7 2011

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

Re: K112068

Trade/Device Name: Synthes Zero-P Variable Angle (VA) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: October 04, 2011 Received: October 05, 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

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Page 2 - Ms. Stacey Bonnell

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 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/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 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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## @ SYNTHES® Spine

## 4 Indications for Use Statement

510(k) Number: K112068 (if known)

Device Name: Synthes Zero-P VA

Indications for Use: The Synthes Zero-P VA 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 VA 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)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

KITZO68 510(k) Number.