ZYSTON STRAIGHT SPACER SYSTEM

K112014 · Biomet Spine · MAX · Oct 17, 2011 · Orthopedic

Device Facts

• Record ID: K112014
• Device Name: ZYSTON STRAIGHT SPACER SYSTEM
• Applicant: Biomet Spine
• Product Code: MAX · Orthopedic
• Decision Date: Oct 17, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Zyston Straight Spacer System is indicated for vertebral body replacement and intervertebral body fusion. When used for vertebral body replacement, the Zyston Straight Spacer System is indicated for use in the thoracolumbar spine (i.e., T1- L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Zyston Straight Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The Zyston Straight Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. When used for vertebral body replacement, the Zyston Straight Spacer System is designed for use with bone graft and is intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine. As an intervertebral body fusion device, the Zyston Straight Spacer System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. When used as an intervertebral body fusion device, the Zyston Straight Spacer System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The Zyston Straight Spacer System may also be implanted using the AccuVision System to provide the surgeon with a minimally invasive approach for posterior or posterolateral spinal surgery.

Device Story

Zyston Straight Spacer System is a spinal implant for vertebral body replacement and intervertebral body fusion; constructed of PEEK-OPTIMA LT1 with tantalum radiographic markers. Implanted by surgeons in clinical settings; may be used with AccuVision System for minimally invasive posterior/posterolateral approaches. Device restores spinal column biomechanical integrity; requires use with bone graft and supplemental fixation systems. Benefits include height restoration of collapsed vertebral bodies and stabilization of spinal segments in patients with degenerative disc disease or spinal tumors/fractures.

Clinical Evidence

Bench testing only. Mechanical performance validated via static/dynamic axial compression, static/dynamic compression-shear, static/dynamic torsion, subsidence, and expulsion testing per ASTM F-2077, ASTM F-2267, and ASTM Draft F-04.25.02.02.

Technological Characteristics

Constructed of PEEK-OPTIMA LT1 (polyetheretherketone) with tantalum radiographic markers. Designed for spinal intervertebral body fusion and vertebral body replacement. Mechanical testing performed per ASTM F-2077, ASTM F-2267, and ASTM Draft F-04.25.02.02.

Indications for Use

Indicated for skeletally mature patients requiring vertebral body replacement (T1-L5) for tumors or fractures, or intervertebral body fusion (L2-S1) for degenerative disc disease with up to Grade 1 spondylolisthesis after 6 months 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

• Ibex Spinal Spacer System (K091381, K050861)
• Expandable PEEK Implant (K082406, K040928)
• ESL Spacer (K092574, K040482)
• Novel LCC Spacer System (K080699)
• AVS PL PEEK Spacer System (K050624, K073470, K082014)

Submission Summary (Full Text)

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Page 1/3 KII 2014

OCT 1 7 2011

Image /page/0/Picture/2 description: The image shows the logo for Biomet Spine. The word "BIOMET" is in a bold, sans-serif font, with the letters connected to each other. Below the word "BIOMET" is the word "SPINE" in a smaller, sans-serif font. The logo is black and white.

#### 510(k) Summary

| Preparation Date: | September 8, 2011 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Applicant/Sponsor: | Biomet Spine (aka EBI, LLC)<br>100 Interpace Parkway<br>Parsippany, NJ 07054 |
| Contact Person: | Julie A. Ryan<br>Phone: [phone], ext. 3310<br>Fax: [phone] |
| Trade name: | Zyston Straight Spacer System |
| Common Name: | Non-cervical spinal spacer<br>Vertebral body replacement |
| Classification Name: | Intervertebral body fusion device, 21 CFR §888.3080<br>Spinal intervertebral body fixation orthosis, 21 CFR §<br>888.3060 |
| Device Panel /Product<br>Code: | Orthopedic MAX<br>Orthopedic MQP |

## Device Description:

The purpose of this submission is the introduction of a new device for intervertebral body fusion and vertebral body replacement. The Zyston Straight Spacer System is constructed of medical grade Polyetheretherketone (PEEK-OPTIMA LT1, a registered trademark of Invibio Limited) and tantalum radiographic markers for spinal applications.

#### Indications for Use:

The Zyston Straight Spacer System is indicated for vertebral body replacement and intervertebral body fusion. When used for vertebral body replacement, the Zyston Straight Spacer System is indicated for use in the thoracolumbar spine (i.e., T1- L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Zyston Straight Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The Zyston Straight Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. When used for vertebral body replacement, the Zyston Straight Spacer System is designed for use with bone graft and is intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.

As an intervertebral body fusion device, the Zyston Straight Spacer System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1

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Image /page/1/Picture/1 description: The image shows the logo for Biomet Spine. The logo is in black and white and features the word "BIOMET" in large, bold letters. Below the word "BIOMET" is the word "SPINE" in smaller letters. The logo is simple and modern.

spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. When used as an intervertebral body fusion device, the Zyston Straight Spacer System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

The Zyston Straight Spacer System may also be implanted using the AccuVision System to provide the surgeon with a minimally invasive approach for posterior or posterolateral spinal surgery.

## Summary of Technologies:

The technological characteristics (material, design and sizing) of the Zyston Straight Spacer System is the same as, or similar to, the predicate devices. Examples of predicate devices include:

- Ibex Spinal Spacer System (K091381, K050861) .
- Expandable PEEK Implant (K082406, K040928) .
- ESL Spacer (K092574, K040482) .
- Novel LCC Spacer System (K080699)
- AVS PL PEEK Spacer System (K050624, K073470, K082014) .

## Performance Data

·

Mechanical testing recommended in the special controls guidance document entitled "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" was conducted. The testing conducted, along with the ASTM standard, are listed below:

- 1) Static Axial Compression (ASTM F-2077)
- 2) Dynamic Axial Compression (ASTM F-2077)
- 3) Static Compression-Shear (ASTM F-2077)
- 4) Dynamic Compression-Shear (ASTM F-2077)
- 5) Subsidence (ASTM F-2267 and ASTM F-2077)

Additional mechanical testing recommended in the special controls guidance document entitled "Guidance for Industry and FDA Staff: Spinal System 510(k)s" was conducted. The testing conducted, along with the ASTM standard, are listed below:

- 1) Static Torsion (ASTM F-2077)
- 2) Dynamic Torsion (ASTM F-2077)
- 3) Expulsion (ASTM Draft F-04.25.02.02)

Mechanical testing shows that the mechanical strength of the subject device is sufficient for the intended use.

#### Substantial Equivalence:

The Zyston Straight Spacer System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and

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Image /page/2/Picture/1 description: The image shows the logo for Biomet Spine. The word "BIOMET" is in a bold, sans-serif font, with each letter outlined in black. Below the word "BIOMET" is the word "SPINE" in a smaller, sans-serif font, also outlined in black. The logo is simple and modern, and the use of black and white gives it a clean and professional look.

principles of operation and do not present any new issues of safety or effectiveness. principles of operation above are distributed for similar indications, and have similar design features.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

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

OCT 1 7 2011

Biomet Spine % Ms. Julie A. Ryan 100 Interpace Parkway Parsippany, New Jersey 07054

"平

Re: K112014

Trade/Device Name: Zyston Straight Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MOP Dated: September 08, 2011 Received: September 09, 2011

Dear Ms. Ryan:

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. Julie A. Ryan

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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Eric Keith

ForMark 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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# Indications for Use

510(k) Number (if known):

Device Name: Zyston Straight Spacer System

Indications for Use:

The Zyston Straight Spacer System is indicated for vertebral body replacement and intervertebral body fusion. When used for vertebral body replacement, the Zyston Straight Spacer System is indicated for use in the thoracolumbar spine (i.e., TI- L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Zyston Straight Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The Zyston Straight Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. When used for vertebral body replacement, the Zyston Straight Spacer System is designed for use with bone graft and is intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.

As an intervertebral body fusion device, the Zyston Straight Spacer System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. When used as an intervertebral body fusion device, the Zyston Straight Spacer System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

The Zyston Straight Spacer System may also be implanted using the AccuVision System to provide the surgeon with a minimally invasive approach for posterior or posterolateral spinal surgery.

Prescription Use X (Part 21 CFR 801 Subpart D)

> ・・ ਸ਼

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

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