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 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.

AI/ML Overview

This document describes a 510(k) premarket notification for the Biomet Spine Fusion System. The submission is to add a tantalum marker to the cam locking mechanism of the existing device. This is a modification to an existing device, not a new AI/ML-enabled device, and therefore does not include the detailed performance study information typically associated with AI/ML device submissions.

Here's a breakdown of the information provided, tailored to the requested categories where applicable:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Mechanical Performance: Demonstrate substantial equivalence to predicate device (K151483) as per FDA guidance and ASTM standards (ASTM F2077 for static/dynamic axial compression, static/dynamic shear compression, static torsion; ASTM F2267 for subsidence).	An engineering analysis demonstrated that no new mechanical testing was required for the modified device (adding a tantalum marker). The analysis demonstrated substantial equivalence of the new subject devices to the predicate device. The modified Biomet Spine Fusion System met all specified criteria.Mechanical testing on the predicate device (K151483) was conducted and demonstrated substantial equivalence to its own predicate devices.
Safety and Effectiveness: The modifications should not raise new safety or performance questions.	The modified Biomet Spine Fusion System met all specified criteria and did not raise new safety or performance questions. The minor differences in the new components (tantalum marker) do not raise any new issues of safety or effectiveness.
Intended Use & Indications for Use: Maintain the same intended use and indications for use as the predicate.	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).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size: Not applicable. For this specific 510(k) submission, there isn't a "test set" in the context of clinical data for an AI/ML device. The evaluation was primarily engineering analysis and mechanical testing comparison to a predicate device.
Data Provenance: Not applicable. The "data" here refers to mechanical testing results and engineering analysis, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. This is not an AI/ML device requiring expert ground truth for image or clinical interpretation. The evaluation was based on engineering and mechanical testing standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. As above, there is no "test set" in the sense of clinical data requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the predicate device's mechanical testing, the "ground truth" would be the established ASTM standards (F2077, F2267) and the performance criteria outlined in FDA guidances (Spinal System 510(k)s, Class II Special Controls Guidance Document: Intervertebral Body Fusion Device). For the current submission, the ground truth is simply the established safety and performance of the predicate device (K151483) against which the minor modification is compared via engineering analysis.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/ML device.

In summary, this 510(k) is for a minor modification (adding a tantalum marker) to an existing, previously cleared spinal fusion device. The "study" proving the device meets acceptance criteria is an engineering analysis, which determined that the modification did not alter the mechanical performance or safety/effectiveness of the device and thus no new mechanical testing or clinical studies were required beyond what was done for the original predicate device.

Summary

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

Image /page/0/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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

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

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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

Indications for Use

510(k) Number (if known)

K153695

Device Name Biomet Spine Fusion System

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

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.310 Interlocken Parkway, Suite 120Broomfield, CO 80021
Contact Person:	Kyle HoeflingRegulatory Affairs Product ManagerPhone: 303-465-8963Fax: 303-501-8444
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:

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

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

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.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
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.(b)
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.