Biomet Spine Fusion System

K153695 · Biomet Spine, LLC · MAX · Jan 21, 2016 · Orthopedic

Device Facts

• Record ID: K153695
• Device Name: Biomet Spine Fusion System
• Applicant: Biomet Spine, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Jan 21, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as a lumbar intervertebral body fusion device, the Biomet Spine Fusion System is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Biomet Spine Fusion System is to be implanted via an anterior or posterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Biomet Spinal Fixation System. The expandable interbody fusion devices are not indicated for vertebral body replacement

Device Story

Biomet Spine Fusion System consists of intervertebral body fusion implants; rectangular/semi-rectangular shapes with hollow centers for autogenous bone graft; transverse grooves on surfaces for stability. Expandable versions feature PEEK spacers and titanium alloy endplates with predetermined lordotic angles (0, 8, 12 degrees). Implants are surgically inserted by surgeons via anterior or posterior approach; must be used with supplemental fixation (e.g., Biomet Spinal Fixation System). Device provides structural support to vertebral space to facilitate spinal fusion; benefits patients by stabilizing spinal segments and reducing discogenic pain. Modification adds tantalum markers to cam locking mechanism for radiographic visualization.

Clinical Evidence

No clinical data. Substantial equivalence supported by engineering analysis of the modified locking mechanism and mechanical testing performed on the predicate device (K151483) per ASTM F2077 (static/dynamic axial compression, shear, torsion) and ASTM F2267 (subsidence).

Technological Characteristics

Materials: PEEK (ASTM F2026), Ti-6Al-4V ELI (ASTM F136), commercially pure titanium (ASTM F1580), tantalum markers (ASTM F560). Expandable form factor with lordotic angles (0, 8, 12 degrees). Provided sterile. Mechanical fixation via cam locking mechanism.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, including patients with prior non-fusion surgery or up to Grade 1 spondylolisthesis/retrolisthesis, who have failed six months of non-operative treatment. Not indicated for vertebral body replacement.

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

• Biomet Spine Fusion System (K151483)

Submission Summary (Full Text)

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

January 21, 2016

Biomet Spine, LLC Mr. Kyle Hoefling Regulatory Affairs Project Manager 310 Interlocken Parkway, Suite 120 Broomfield, Colorado 80021

Re: K153695

Trade/Device Name: Biomet Spine Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 22, 2015 Received: December 23, 2015

Dear Mr. Hoefling:

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 Parts 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 [phone] or [phone] 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 [phone] or [phone] 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)

K153695

Device Name Biomet Spine Fusion System

#### Indications for Use (Describe)

When used as a lumbar intervertebral body fusion device, the Biomet Spine Fusion System is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Biomet Spine Fusion System is to be implanted via an anterior or posterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Biomet Spinal Fixation System. The expandable interbody fusion devices are not indicated for vertebral body replacement

### 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

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Image /page/3/Picture/0 description: The image shows the logo for Biomet Spine. The word "BIOMET" is in large, bold, sans-serif font. Below that, in a smaller font, is the word "SPINE". The logo is simple and modern.

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.

| Preparation Date: | December 22, 2015 |
|---------------------------------|-------------------------------------------------------------------------------------------------|
| Applicant/Sponsor: | Biomet Spine LLC.<br>310 Interlocken Parkway, Suite 120<br>Broomfield, CO 80021 |
| Contact Person: | Kyle Hoefling<br>Regulatory Affairs Product Manager<br>Phone: [phone]<br>Fax: [phone] |
| Trade Name: | Biomet Spine Fusion System |
| Common Name: | Intervertebral Body Fusion Device, Lumbar |
| Device Class: | Class II |
| Classification Name | Intervertebral fusion device with bone graft, lumbar |
| Product Code: | MAX |
| Device Panel - Regulation No .: | Orthopedic - 21 CFR 888.3080 |
| Primary Predicate: | Biomet Spine Fusion System K151483 |

# Device Description:

The Biomet Spine Fusion System implants are intervertebral body fusion/vertebral body replacement devices consisting of a rectangular or semi-rectangular shape and various heights and footprints. The devices have a hollowed out central area to accommodate bone graft. The upper and lower surfaces of the devices have a series of transverse grooves formed to improve stability and fixation once the device is inserted. The implants are available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The implants are made of PEEK (OPTIMA LT1®) per ASTM F2026, titanium alloy (Ti-6A1-4V ELI) per ASTM F136, commercially pure titanium per ASTM F1580, and may include tantalum markers per ASTM F560. The expandable Biomet Spine Fusion System implants incorporate PEEK (OPTIMA LT1® per ASTM F2026) spacer components and titanium alloy (Ti-6Al-4V ELI per ASTM F136) endplate components that orient into predetermined lordotic angles of 0, 8 and 12 degrees. The expandable implants are available in 7 to 14mm heights, an 11mm width, and 25, 30 and 35mm lengths. The subject Biomet Spine Fusion System implant is provided sterile only.

### Indications for Use:

When used as a lumbar intervertebral body fusion device, the Biomet Spine Fusion System is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature

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patients with degenerative disc disease ("DD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Biomet Spine Fusion System is to be implanted via an anterior or posterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Biomet Spine Spinal Fixation System. The expandable interbody fusion devices are not indicated for vertebral body replacement.

### Summary of Technologies:

The technological characteristics of the subject Biomet Spine Fusion System components remain the same as, or similar to, the predicate devices in regards to intended use, indications for use, design, manufacturing methods, fundamental technology, and operational principles. The purpose of this submission is to add a tantalum marker to the cam locking mechanism.

### Performance Data:

An engineering analysis was performed to assess the introduction of tantalum markers within the locking mechanism of the subject expandable Biomet Spine Fusion System product family. The worst case construct was identified and characterized. The results of this engineering analysis demonstrated that no new mechanical testing is required. The analysis demonstrated the substantial equivalence of the new subject devices to the predicate device. The modified Biomet Spine Fusion System met all specified criteria and did not raise new safety or performance questions.

Mechanical testing on the predicate device (K151483) was conducted in accordance with FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s dated May 3, 2004 and Class II Special Controls Guidance Document: Intervertebral Body Fusion Device dated June 12, 2007. Performance testing included tests per ASTM F2077 (static and dynamic axial compression, static and dynamic shear compression, and static torsion) and ASTM F2267 (subsidence) and was performed to demonstrate substantial equivalence to the predicate device(s).

# Substantial Equivalence:

The modified Biomet Spine Fusion System implants included in this submission have the same intended use, indications, technological characteristics, and principles of operation as the previously cleared Biomet Spine Fusion System (K151483). The minor differences in the new components do not raise any new issues of safety or effectiveness.

### Conclusion:

The Biomet Spine Fusion System is substantially equivalent to the predicate systems as a spinal fusion device in regards to intended use, indications for use, fundamental technology including design, manufacturing methods, sterility, and operational principles. Furthermore, an engineering analysis and other supporting information sufficiently demonstrate the substantial equivalence of the subject components to the Biomet Spine Fusion System to the predicate system. Based on this information, the subject modifications do not raise any new issues regarding the safety or efficacy when compared to its predicates.