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 to treatment with the device. The device may be used with supplemental fixation. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft 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. Patients should have received 6 months of non-operative treatment with the devices. The device is a standalone system intended to be used with the bone screws provided and requires no additional supplementary fixation. 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.

The Endoskeleton® TO IBD 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 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. These DDD patients may also I spondylolisthesis or retrolistesis at the involved level(s). It is indicated to be used with autograft bone.

The Endoskeleton® TT IBD 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 and radiographic studies. Patients should have received 6 months of non-operative treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also I spondylolisthesis or retrolistesis at the involved level(s). It is indicated to be used with autograft bone.

The Endoskeleton® TC is indicated for use for anterior cervical interbody 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 radios. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device. The Endoskeleton® TC is indicated to be used with supplemental fixation and autograft bone.

The Endoskeleton® TL IBD 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 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 non-fusion spinal surgery at the involved level(s) may be treated with the device. It is indicated to be used with autograft bone.

The ENDOSKELETON® TA VBR 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 VBR is intended for use with supplemental internal spinal fixation systems. The ENDOSKELETON® TA VBR may be used with bone graft material or bone graft substitute.

Device Description

This special 510(k) is intended to modify the sterilization of the Endoskeleton® system from non-sterile to sterile via gamma irradiation.

The Endoskeleton system is an interbody and vertebral body system comprised of a variety of implant sizes and geometries to accommodate various patient anatomy and pathology. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).

AI/ML Overview

The document provided does not describe a study that uses acceptance criteria to prove the device meets these criteria in the context of an AI/ML algorithm or a comparative effectiveness study. Instead, it is a 510(k) premarket notification for a medical device (Endoskeleton® System) that focuses on substantial equivalence to predicate devices, particularly regarding a change in sterilization method from non-sterile to sterile via gamma irradiation.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not present in this document.

However, I can extract the information that is available:

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

The document focuses on substantial equivalence for a change in sterilization method. The "acceptance criteria" here are implied to be that the new sterilization method (gamma irradiation) effectively sterilizes the device without negatively impacting its other characteristics, thus maintaining substantial equivalence to the non-sterile predicate devices.

Acceptance Criterion (Implied)	Reported Device Performance
Device is sterile after processing	Sterilization validation was completed to verify that the subject devices are sterilized via gamma irradiation.
Device maintains substantial equivalence to predicate devices (indications for use, design, dimension, materials, surface treatment)	"There are no changes between the predicate devices and the subject devices with respect to indications for use, design, dimension, surface treatment and materials. The only difference to the currently marketed devices is the change in sterilization."

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

Not applicable. The document describes a 510(k) submission for a physical medical device (interbody fusion system) and a change in its sterilization method, not a study involving a test set for an AI/ML algorithm or data analysis. The "sterilization validation" would typically involve samples of the device and testing for sterility, but the specific sample size and detailed provenance of that testing are not provided in this summary.

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. No ground truth for a test set (in the context of AI/ML or diagnostic performance) is established in this document.

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

Not applicable. No adjudication method for a test set is mentioned.

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 document does not describe an AI/ML device or an MRMC study.

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

Not applicable. This document does not describe an AI/ML algorithm.

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

Not applicable in the context of an AI/ML algorithm. For the sterilization validation, the "ground truth" would be the standard scientific and regulatory methods for proving sterility (e.g., microbial challenges, physical testing), but specific details are not provided.

8. The sample size for the training set:

Not applicable. This document is not about an AI/ML algorithm with a training set.

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

Not applicable. This document is not about an AI/ML algorithm with a training set.

Summary

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing to the right, with flowing lines suggesting movement or connection. The profiles are arranged in a way that they appear to be overlapping. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the design.

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

October 17, 2014

Titan Spine, LLC % Ms. Kimberly Strohkirch Managing Partner Memphis Regulatory Consulting, LLC 3416 Roxee Run Cove Bartlett, Tennessee 38133

Re: K142589

Trade/Device Name: Endoskeleton® System (Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP, OVD, MQP Dated: September 24, 2014 Received: September 25, 2014

Dear Ms. Strohkirch:

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.

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

Page 2 - Ms. Kimberly Strohkirch

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 forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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 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,

Ronald刷Alean -S for

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

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)

K142589

K142589 Page 1 of 3

Device Name Endoskeleton® System

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)

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)

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

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

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."

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

510(k) Summary

Endoskeleton® System September 12, 2014

Company:	Titan Spine, LLC6140 W. Executive Drive, Suite AMequon, WI 53092, USA
EstablishmentRegistration:	3006340236
Primary Contact:	Kimberly StrohkirchPhone: 901-361-2037
Company/SecondaryContact:	Jane RoddPhone: 866-822-7800Fax: 262-242-7802
Trade Name:	""""""""""ENDOSKELETON® System -ENDOSKELETON® TA Interbody Fusion Device,Endoskeleton® TAS Interbody Fusion Device,Endoskeleton® TO Interbody Fusion Device,Endoskeleton® TT Interbody Fusion Device,Endoskeleton® TC Interbody Fusion Device,Endoskeleton® TL Interbody Fusion Device,ENDOSKELETON® TA Vertebral Body Replacement.
Common Name:	Intervertebral body fusion deviceIntervertebral fusion device with bone graft, cervicalIntervertebral fusion device with bone graft, lumbarIntervertebral fusion device with integrated fixation, lumbarSpinal vertebral body replacement deviceENDOSKELETON® TA VBR
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

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

Product Code: MAX, ODP, OVD, MQP

Device Description:

This special 510(k) is intended to modify the sterilization of the Endoskeleton® system from non-sterile to sterile via gamma irradiation.

Indications 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 prior to treatment with the device may be used with supplemental fixation. 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.

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. Patients should have received 6 months of non-operative treatment prior to treatment with the device is a standalone system intended to be used with the bone screws provided and requires no additional supplementary fixation. 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.

The Endoskeleton® TO IBD 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. 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.

The Endoskeleton® TT IBD 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

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

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. 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.

The Endoskeleton® TC 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 is indicated to be used with supplemental fixation and autograft bone.

Substantial Equivalence:

The proposed modifications to the Endoskeleton® devices are identical to predicate devices previously cleared by Titan Spine (Endoskeleton TA - K080615"]r tho ct ("rtgflecy , Endoskeleton TAS ó"M33848."Endoskeleton TT – K083714. Endoskeleton TO – K102067. Endoskeleton TC – K100889. Endoskeleton TL – K140055 and Endoskeleton TA VBR – K032812) with respect to indications for use, design, dimension, and materials. The only difference to the currently marketed devices is the change in sterilization.

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

Technological Characteristics

There are no changes between the predicate devices and the subject devices with respect to indications for use, design, dimension, surface treatment and materials. The only difference to the currently marketed devices is the change in sterilization. The subject components are provided sterile via gamma irradiation as opposed to the predicates that are provided non-sterile.

Performance Testing:

Sterilization validation was completed to verify that the subject devices are sterilized via gamma irradiation.

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.