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 pattents 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 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 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 with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis 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 have up to Grade I spondylolisthesis 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.

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 traditional 510(k) is intended to modify the surface treatment of Endoskeleton devices.

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. The modified surface technology provides a microscopic roughened surface with nano-scale features. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Endoskeleton® System, which includes various interbody fusion devices and a vertebral body replacement device. This submission focuses on a modification to the surface treatment of existing devices, rather than a new device with novel indications for use. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily related to demonstrating that the modified device is substantially equivalent to the predicate devices, particularly regarding its mechanical performance, biocompatibility, and integrity.

The document does not detail specific acceptance criteria in the form of numerical thresholds for metrics like sensitivity, specificity, or accuracy, as would be typical for an AI/ML device. Instead, the "acceptance criteria" are implied by the regulatory requirement to demonstrate substantial equivalence to previously cleared devices. The "study" refers to the performance testing conducted to show that the new surface treatment does not negatively impact the device's safety and effectiveness compared to the predicate devices.

Here's a breakdown of the requested information based on the provided text, recognizing the context of a medical device modification rather than an AI/ML diagnostic tool:

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

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Strength: Device must maintain adequate mechanical strength for intended use, comparable to predicate devices. (Demonstrated by ASTM F2077)	Axial fatigue testing performed per ASTM F2077. The testing indicated that the Endoskeleton® devices are adequate for the intended use and substantially equivalent to the predicate systems.
Surface Integrity: New surface treatment must maintain integrity over time and under conditions of use.	Surface specific characterization and integrity testing were completed. (Implicitly, these tests supported the conclusion of substantial equivalence).
Biocompatibility: Device with new surface must be biocompatible, comparable to predicate devices. (Demonstrated by ISO 10993-1)	Biocompatibility per ISO 10993 was established through ISO 10993-1 assessment and an implantation animal model. The testing indicated that the Endoskeleton® devices are adequate for the intended use and substantially equivalent to the predicate systems. (This implies that the new surface treatment did not introduce new biocompatibility concerns and met the standard).
Wear Characteristics: Wear properties should be acceptable and comparable to predicate devices. (Demonstrated by modified ASTM F1160)	Wear testing was done using a modified protocol of ASTM F1160 with particulate characterization. (Implicitly, the results supported the conclusion of substantial equivalence).
Substantial Equivalence: All modified devices must remain substantially equivalent to predicate devices with respect to indications for use, design, dimension, and materials (except for the surface treatment).	The subject Endoskeleton® device is identical to the predicate devices with respect to indications for use, design, dimension, and materials. The only difference to the currently marketed devices is the change in surface treatment. "The testing indicated that the Endoskeleton® devices are adequate for the intended use and substantially equivalent to the predicate systems."

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

The document refers to mechanical and biocompatibility testing rather than a clinical "test set" in the context of diagnostic accuracy.

Sample Size: Not explicitly stated. For mechanical and biocompatibility testing of medical devices, sample sizes are typically determined by relevant ISO/ASTM standards (e.g., ISO 10993, ASTM F2077, ASTM F1160) and statistical power analysis specific to the test type. They would refer to the number of device components or animal subjects tested, not patient data.
Data Provenance: Not applicable in the sense of country of origin of patient data. The provenance of the testing would be controlled laboratory environments where the mechanical and biocompatibility tests were conducted.

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 a study involving expert review of diagnostic data to establish ground truth. The "ground truth" for this submission is established by the specifications of the device itself and the requirements of the standards (ASTM, ISO) for mechanical properties and biocompatibility.

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

Not applicable. This type of adjudication method is used for establishing ground truth in clinical/diagnostic studies, which is not the nature of the testing described here.

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 submission is for a physical medical device (intervertebral body fusion device), not an AI-assisted diagnostic tool.

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

Not applicable. This submission is for a physical medical device.

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

For this device modification, the "ground truth" is a combination of:

Engineering Specifications and Standard Requirements: The acceptance criteria are based on established ISO and ASTM standards for the mechanical properties and biocompatibility of implantable devices. The device must meet these standards to ensure safety and effectiveness.
Predicate Device Performance: The primary "ground truth" for demonstrating substantial equivalence is the known, cleared performance of the predicate devices. The modified device must perform comparably to these established devices.

8. The sample size for the training set

Not applicable. This type of "training set" is relevant for AI/ML algorithms, not for the physical device modification described.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm.

Summary

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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 circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or ribbons.

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

October 27, 2014

Titan Spine, LLC % Christine Scifert, MS, MEM Memphis Regulatory Consulting, LLC 3416 Roxee Run Cove Bartlett, Tennessee 38133

Re: K141953

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, OVD, ODP, MQP Dated: October 3, 2014 Received: October 6, 2014

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. 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

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Page 2 - Christine Scifert, MS, MEM

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 P. Jean -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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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.

K141953 Page 1 of 3

510(k) Number (if known)

K141953

Device Name Endoskeleton(R) 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)

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

K141953

Page 3 of 3

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:

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"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."

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510(k) Summary

Endoskeleton® System October 21, 2014

Company:	Titan Spine, LLC6140 W. Executive Drive, Suite AMequon, WI 53092, USA
EstablishmentRegistration:	3006340236
Primary Contact:	Christine ScifertPhone: 901-831-8053
Company/SecondaryContact:	Jane RoddPhone: 866-822-7800Fax: 262-242-7802
Trade Name:	Endoskeleton® SystemENDOSKELETON® 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 device
Classification:	Class II
Regulation Number:	21 CFR 888.3080 (Intervertebral body fusion device)21 CFR 888.3060 (Spinal intervertebral body fixation orthosis)

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Panel:	87- Orthopedic
Product Code:	OVD. MAX. ODP. MOP

Device Description:

This traditional 510(k) is intended to modify the surface treatment of Endoskeleton devices.

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 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.

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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 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.

Substantial Equivalence:

The proposed modifications to the Endoskeleton® devices are identical to predicate devices previously cleared by Titan Spine:

Predicate: Endoskeleton TAS K111626 .
. Other predicates: Endoskeleton TA - K080615, Endoskeleton TT - K083714, Endoskeleton TO - K102067, Endoskeleton TC - K100889, Endoskeleton TL -K140055 and Endoskeleton TA VBR - K032812

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The subject Endoskeleton® device is identical to the predicate devices with respect to indications for use, design, dimension, and materials. The only difference to the currently marketed devices is the change in surface treatment.

Technological Characteristics

There are no changes between the predicate devices and the subject devices with respect to indications for use, design, dimension, and materials. The only difference to the currently marketed devices is the change in surface treatment. There are additional processing steps for the new surface treatment when compared to the previous surface treatment.

Performance Testing:

Mechanical testing was performed to establish mechanical strength of the devices (ASTM F2077). Surface specific characterization and integrity testing were completed to support biocompatibility through ISO 10993-1. Pre-clinical testing performed included axial fatigue testing per ASTM F2077. Additionally, wear testing was done using a modified protocol of ASTM F1160 with particulate characterization. Biocompatibility per ISO 10993 was established through ISO 10993-1 assessment and an implantation animal model. The testing indicated that the Endoskeleton® devices are adequate for the intended use and substantially equivalent to the predicate systems.

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.