SYNTHES ZERO-P VARIABLE ANGLE (VA)

K121852 · Synthes Spine Co.Lp · OVE · Jul 25, 2012 · Orthopedic

Device Facts

• Record ID: K121852
• Device Name: SYNTHES ZERO-P VARIABLE ANGLE (VA)
• Applicant: Synthes Spine Co.Lp
• Product Code: OVE · Orthopedic
• Decision Date: Jul 25, 2012
• Decision: SESE
• Submission Type: Special
• 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 an intervertebral body fusion device for anterior cervical spine surgery. It consists of a PEEK-Optima spacer with a titanium alloy radiopaque marker for intra-operative positioning assessment. The spacer is preassembled with a titanium alloy interbody plate and secured using two titanium alloy screws. The system includes a lock-catch mechanism (titanium alloy lock-screw, catch, and Elgiloy spring) to secure the screws. The device is implanted by a surgeon via an anterior approach; the spacer interior is packed with autogenous bone graft to facilitate fusion. This specific submission covers the addition of sterile-packed screws to the existing product line. The device provides structural support and stabilization to the cervical spine, aiming to alleviate discogenic pain and promote fusion in patients with degenerative disc disease.

Clinical Evidence

No clinical data was required or provided for this device.

Technological Characteristics

Materials: PEEK-Optima LT-1 (ASTM F2026), Titanium alloy (Ti-6Al-4V ELI; ASTM F136-2a), Titanium alloy (Ti-6Al-7Nb; ASTM F1295), Elgiloy (ASTM F1058). Features: Radiolucent spacer with radiopaque marker, integrated interbody plate, screw-based fixation with lock-catch mechanism. Dimensions: 3.7mm diameter screws. Sterilization: Sterile-packed screws.

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 device (K093762, K112459)
• Synthes Zero-P VA device (K112068)

Submission Summary (Full Text)

{0}------------------------------------------------

**SYNTHES**®
Spine

ア
[

","s"

K121852

1.

11. 510(k) Summary

| 510(k) Summary | | |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Name of Firm: | Synthes Spine<br>1302 Wrights Lane East<br>West Chester, PA 19380 | |
| 510(k) Contact: | Monika McDole-Russell<br>Regulatory Affairs Specialist, Synthes Spine<br>Telephone: [phone]<br>Facsimile: 610-719-5102<br>Email: [e-mail] | |
| Date Prepared: | June 22, 2012 | |
| 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 with Integrated<br>Fixation, Cervical) | |
| Predicates: | Synthes Zero-P device (K093762, K112459)<br>Synthes Zero-P VA device (K112068) | |
| 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 ELI;<br>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. The<br>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 F1058)<br>spring. The screws offered with the Zero-P VA system are 3.7mm in<br>diameter and are currently offered non-sterile. This line extension<br>covers the addition of sterile-packed screws. | |
| Intended Use/<br>Indications for Use: | The Synthes Zero-P VA 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 VA should be packed with autogenous bone | |
| | | |
| | graft and implanted via an anterior approach. | |
| Comparison of the<br>device to predicate<br>device(s): | The modifications herein presented to the Synthes Zero-P VA<br>device are substantially equivalent to the above referenced<br>predicates in design, function, and intended use. | |
| Performance Date<br>(Nonclinical and/or<br>Clinical): | Non-Clinical Performance and Conclusions:<br>Non-clinical performance data and conclusions were not needed for<br>this device. | |
| | Clinical Performance and Conclusions<br>Clinical data and conclusions were not needed for this device. | |

Synthes Zero-P VA – Sterile-Packed Screws Special 510(k)

. ·

sheet 1 of 2

{1}------------------------------------------------

**SYNTHES**®

. . . .

i

i

Spine

the control control control controlled

Synthes Zero-P VA – Sterile-Packed Screws Special 510(k) .

:

sheet 2 of 2

・

.

.

{2}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized abstract design resembling an eagle or bird in flight, positioned to the right of the department's name. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the left side of the emblem. The design is simple, using only black and white.

## Public Health Service

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

Synthes Spine % Ms. Monika McDole-Russell Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380

JUL 25 2012

Re: K121852

Trade/Device Name: Synthes Zero-P VA Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: June 22, 2012 Received: June 25, 2012

Dear Ms. McDole-Russell:

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

{3}------------------------------------------------

Page 2- Ms. Monika McDole-Russell

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 A. Millman

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

Enclosure

{4}------------------------------------------------

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

**Spine**

## 10. Indications for Use Statement

510(k) Number: (if known)

K 121852

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 ievel 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 × (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

sheet 1 of 1

K121852 510(k) Number_

Synthes Zero-P VA - Sterile Screws Special 510(k)