The ENDOSKELETON® TA Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the device is intended to be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). ENDOSKELETON® TA is indicated to be used with autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone.

The ENDOSKELETON® TAS Interbody Fusion device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received 6 months of nonoperative treatment prior to treatment with the device is a standalone system that is intended to be used with the bone screws provided and requires no additional supplementary fixation. The Device is indicated to be used with autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone.

Hyperlordotic Devices >16': The ENDOSKELETON® TAS Hyperlordotic Interbody Fusion Device (> 16') is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Patients should have received 6 months of non-operative treatment with the devices. The device is indicated to be used with autograft bone comprised of cancellous and/ or corticocancellous bone. The ENDOSKELETON® TAS Hyperlordotic Interbody Fusion Device must be used with a posterior supplemental internal spinal fixation that has been cleared by the FDA for use in the lumbar spine.

The ENDOSKELETON® TO Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone comprised of cancellous and/ or corticocancellous bone.

The ENDOSKELETON® TT Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non- operative treatment with the devices. The devices. The device must be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone comprised of cancellous and/ or corticocancellous bone.

The ENDOSKELETON® TC Interbody Fusion Device is indicated for use for anterior cervical interbody fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C-3 to C-7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received 6 weeks of non-operative treatment with the device. The ENDOSKELETON® TC Interbody Fusion Device is indicated to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine and autograft bone comprised of cancellous and/ or corticocancellous bone.

The Endoskeleton® TCS Interbody Fusion Device System is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment with the device. The device is indicated to be used with autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone. The device is a standalone system when used with Endoskeleton® TCS interrated screws and when used without the integrated screws it requires additional supplemental fixation cleared for the cervical spine.

The ENDOSKELETON® TL Interbody Fusion Device is indicated for use in spinal fusion procedures in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment with the devices. This devices. This device is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients with previous non-fusion spinal surgery at the involved level(s) may be treated with the device. It is indicated to be used with autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone.

The ENDOSKELETON® TA Vertebral Body Replacement is for use in the thoracolumbar spine (T1 - L5) to replace all or part of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The ENDOSKELETON® TA Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems that has been cleared by the FDA for use in the lumbar spine. The ENDOSKELETON® TA Vertebral Body Replacement may be used with bone graft material and/or allogeneic bone graft.

Device Description

The current Endoskeleton® system is an interbody and vertebral body family comprised of a variety of sizes and geometries to accommodate various patient anatomy and pathology. All implantable components are manufactured from medical grade titanium alloy (Ti6A14V-ELI). The center of the implant is hollow and is to be filled with autograft material. The design incorporates "windows" through the implant to permit visualization of the graft material and, over time, formation of new bone. This submission seeks to expand the indications of these devices to include use with allograft material.

The predicate Endoskeleton® System (K173535, K170399, and K141953) is provided either non-sterile or sterile via gamma irradiation. The Endoskeleton® TA VBR (K032812) was initially manufactured and submitted by Orthovita, Inc (Malvern, PA). Titan Spine has the 510(k) and maintains the device listing for the device.

AI/ML Overview

The provided document is a 510(k) summary for the Titan Spine Endoskeleton® Interbody Fusion Devices and Vertebral Body Replacement Device. This submission is for a modification to the indications for use, specifically to include the use of allograft material. The document explicitly states that no performance testing was required or performed because the modification relates only to the indications for use and not to the device's design, materials, or function.

Therefore, the study design and associated criteria for "device performance" (as would be tested in a typical clinical or technical performance study) are not applicable or reported in this document. The "proving" of acceptance criteria in this context relies on a literature review to establish substantial equivalence with predicate devices, rather than empirical testing of the device itself.

Since the request asks for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of device performance, and the document clarifies that no such testing was conducted, I will state that directly.

Here's the breakdown of the requested information based on the provided document:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not applicable.	Not applicable. The modification was related to Indications for Use (inclusion of allograft material), and no performance testing was required or performed for this 510(k) submission.

2. Sample sized used for the test set and the data provenance

Sample size for test set: Not applicable. No performance testing was conducted.
Data provenance: Not applicable. The basis for this 510(k) was a comprehensive literature review.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No test set was used for device performance evaluation. The determination of substantial equivalence was based on a literature review which concluded no additional risks for the modified indications.

4. Adjudication method for the test set

Not applicable. No test set was used.

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 a medical device (spinal implant), not an AI/software device. No MRMC study was conducted.

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

Not applicable. This is a medical device (spinal implant), not an algorithm/software device.

7. The type of ground truth used

Not applicable in the context of device performance testing. The "ground truth" for the current submission was established through a comprehensive literature review to assess the safety and equivalence of using allograft material with the existing devices.

8. The sample size for the training set

Not applicable. No training set was used as no AI/software component is involved, and no performance testing was conducted.

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

Not applicable. No training set was used.

Summary regarding the "study that proves the device meets the acceptance criteria":

For this specific 510(k) submission (K183557), the device itself (Titan Spine Endoskeleton® Interbody Fusion Devices and VBR Device) was not subjected to new performance testing. The application was a "Special 510(k)" for a modification to the Indications for Use, specifically to add the use of allograft material.

The document explicitly states: "No performance testing was required or performed, as this modification for this Special 510(k) relates only to the indications for use." and "A comprehensive literature review was conducted to assess any additional safety concern for the use of these devices with allograft. The review of the literature concluded that there were no additional risks due to the modification of the indications of these devices to include use with allograft and that these devices are substantially equivalent to the predicate devices."

Therefore, the "proof" that the device (with the expanded indication) meets acceptance criteria comes from a comprehensive literature review demonstrating no additional safety concerns or changes in substantial equivalence due to the inclusion of allograft material. This relies on the established performance and safety profile of the predicate devices and existing knowledge regarding allograft use in similar surgical contexts. There were no specific, quantifiable "acceptance criteria" related to a performance study for this particular submission because no such study was deemed necessary.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

February 11, 2019

Titan Spine, Inc % Christine Scifert Executive VP MRC/X, LLC 6075 Poplar Ave. Memphis. Tennessee 38119

Re: K183557

Trade/Device Name:	Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS InterbodyFusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TTInterbody Fusion Device, Endoskeleton® TC Interbody Fusion Device,Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL InterbodyFusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device
Regulation Number:	21 CFR 888.308021 CFR 888.3060
Regulation Name:	Intervertebral Body Fusion DeviceSpinal Intervertebral Body Fixation Orthosis
Regulatory Class:	Class II
Product Code:	ODP, MAX, OVD, OVE, MQP
Dated:	January 21, 2019
Received:	January 23, 2019

Dear Ms. Scifert:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Melissa Hall -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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510(k) Number (if known)

K183557

Device Name

ENDOSKELETON® TA Interbody Fusion Device

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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510(k) Number (if known)

K183557

Device Name

ENDOSKELETON® TAS Interbody Fusion device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
------------------------------------------------------------------------------------------------	---------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.

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

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

510(k) Number (if known)

K183557

Device Name

ENDOSKELETON® TO Interbody Fusion Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.

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

{5}------------------------------------------------

510(k) Number (if known)

K183557

Device Name

ENDOSKELETON® TT Interbody Fusion Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	---------------------------------------	---------------------------------------

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.

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

{6}------------------------------------------------

510(k) Number (if known)

K183557

Device Name

ENDOSKELETON® TC Interbody Fusion Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.

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

{7}------------------------------------------------

510(k) Number (if known)

K183557

Device Name

ENDOSKELETON® TCS Interbody Fusion Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.

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

{8}------------------------------------------------

510(k) Number (if known)

K183557

Device Name

ENDOSKELETON® TL Interbody Fusion Device

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.

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

{9}------------------------------------------------

510(k) Number (if known) K183557

Device Name

ENDOSKELETON® TA Vertebral Body Replacement (VBR) Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.

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

{10}------------------------------------------------

510(k) Summary

Endoskeleton® System

Company:	Titan Spine, Inc.6140 West Executive Drive, Suite AMequon, WI 53092, USA
EstablishmentRegistration:	3006340236
Primary Contact:	Christine ScifertPhone: 901-831-8053
Company Contact:	Jane RoddPhone: 866-822-7800Fax: 262-242-7802
Trade Name:	Endoskeleton® TA Interbody Fusion DeviceEndoskeleton® TAS Interbody Fusion DeviceEndoskeleton® TO Interbody Fusion DeviceEndoskeleton® TT Interbody Fusion DeviceEndoskeleton® TC Interbody Fusion DeviceEndoskeleton® TCS Interbody Fusion DeviceEndoskeleton® TL Interbody Fusion DeviceEndoskeleton® TA Vertebral Body Replacement (VBR) Device
Common Name:	Intervertebral Fusion Device With Integrated Fixation, LumbarIntervertebral Fusion Device With Bone Graft, CervicalIntervertebral Fusion Device With Integrated Fixation, CervicalIntervertebral Fusion Device With Bone Graft, LumbarSpinal Vertebral Body Replacement Device
Classification:	Class II
Regulation Number:	21 CFR 888.3080 (Intervertebral body fusion device)21 CFR 888.3060 (Spinal intervertebral body fixation orthosis)
Panel:	87- Orthopedic
Product Code:	ODP, OVD, OVE, MAX, MQP
Predicate Devices:	Primary Predicate:HD LifeSciences, LLC Lumbar Interbody System – K170676Secondary Predicates:HD LifeSciences, LLC Cervical IBFD System – K180364NuVasive® Modulus C Interbody System – K172676

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Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System -K171686 Endoskeleton® TAS and TCS - K173535 Endoskeleton® TO - K170399 Endoskeleton® System (TA IBD and VBR, TO, TT, TAS, TC, TL) - K141953

Device Description:

Indication for Use:

The ENDOSKELETON® TA Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment with the devices. The device is intended to be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). ENDOSKELETON® TA is indicated to be used with autograft bone or allograff bone comprised of cancellous and/ or corticocancellous bone.

The ENDOSKELETON® TAS Interbody Fusion device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received 6 months of non-operative treatment with the devices. The device is a standalone system that is intended to be used with the bone screws provided and requires no additional supplementary fixation. The Device is indicated to be used with autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone.

Hyperlordotic Devices ≥16': The ENDOSKELETON® TAS Hyperlordotic Interbody Fusion Device (≥ 16°) is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received 6 months of nonoperative treatment prior to treatment with the device is indicated to be used with autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone. The ENDOSKELETON® TAS Hyperlordotic Interbody Fusion Device must be used with a posterior supplemental internal spinal fixation that has been cleared by the FDA for use in the lumbar spine.

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The ENDOSKELETON® TO Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment with the devices. The device must be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone.

The ENDOSKELETON® TT Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non- operative treatment with the devices. The device must be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone.

The ENDOSKELETON® TC Interbody Fusion Device is indicated for use for anterior cervical interbody fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C-3 to C-7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device. The ENDOSKELETON® TC Interbody Fusion Device is indicated to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine and autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone.

The Endoskeleton® TCS Interbody Fusion Device System is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device is indicated to be used with autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone. The device is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared for the cervical spine.

The ENDOSKELETON® TL Interbody Fusion Device is indicated for use in spinal fusion procedures in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. This device is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients with previous non-fusion spinal surgery at the involved level(s) may be treated with the device. It is indicated to be used with autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone.

The ENDOSKELETON® TA Vertebral Body Replacement is for use in the thoracolumbar spine (T1 -L5) to replace all or part of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The ENDOSKELETON® TA Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems that has been cleared by the FDA for use in the lumbar

{13}------------------------------------------------

spine. The ENDOSKELETON® TA Vertebral Body Replacement may be used with bone graft material and/or allogeneic bone graft.

Substantial Equivalence:

Titan Spine has 14 previous clearance related to the predicate Endoskeleton® systems. The most recent clearances for each sub-family are provided below for the primary and secondary predicates:

Primary Predicate:	HD LifeSciences, LLC Lumbar Interbody System – K170676
Secondary Predicates:	HD LifeSciences, LLC Cervical IBFD System – K180364
	NuVasive® Modulus-C Interbody System – K172676
	Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System –K171686
	Endoskeleton TAS and TCS – K173535
	Endoskeleton TO – K170399
	Endoskeleton® System (TA IBD and VBR, TO, TT, TAS, TC, TL) – K141953

The modification for this Special 510(k) relates only to indications for use. The intended use, material, surgical technique, surface treatment, sterility, and design of the subject devices are the same as predicate devices. The only change that is the subject of this submission is to change the indication for use with allograft material.

A comprehensive literature review was conducted to assess any additional safety concern for the use of these devices with allograft. The review of the literature concluded that there were no additional risks due to the modification of the indications of these devices to include use with allograft and that these devices are substantially equivalent to the predicate devices.

Technological Characteristics:

The modification for this Special 510(k) relates only to the indications for use. The intended use, material, surgical technique, surface treatment, sterility, and design of the subject devices are the same as predicate devices.

Performance Testing:

No performance testing was required or performed, as this modification for this Special 510(k) relates only to the indications for use.

Biocompatibility:

There are no changes to the Endoskeleton® System materials. The devices are patient contacting and are implanted for durations greater than 30 days. All implant components of the Endoskeleton® devices are made from medical grade titanium (Ti6A14V-ELI) alloy per ASTM F-136/ISO 5832-3 and ASTM F-3001.

Conclusion:

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Based upon the clinical literature contained in this submission and the similarities of the subject and predicate devices, the subject Endoskeleton® system is substantially equivalent to the predicate devices.

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.