The Tritanium® C Anterior Cervical Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 to T1 disc.

DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy.

The Tritanium® C Anterior Cervical Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.

The Tritanium® C Anterior Cervical Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.

Device Description

The Stryker Spine Tritanium® C Anterior Cervical Cage is a hollow, ring shaped titanium alloy (Ti-6Al-4V) interbody fusion cage intended for use in the cervical spine. The cage consists of an open window for bone graft containment and has serrations on the superior and inferior surfaces of the cage for fixation. The cage is offered in a variety of footprints, heights, and lordotic angles to adapt to varying patient anatomies. The Tritanium® C Anterior Cervical Cage consists of a unique configuration of both solid and porous structures that are simultaneously built using Laser Rapid Manufacturing (LRM) method applying Stryker's proprietary Tritanium® In-Growth Technology. The Tritanium® C Anterior Cervical Cage is provided sterile.

AI/ML Overview

This document is a 510(k) summary for the Stryker Spine Tritanium® C Anterior Cervical Cage, an intervertebral body fusion device. It details the device's characteristics, intended use, and the non-clinical testing performed to establish substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Standard/Guidance Referenced)	Reported Device Performance
Mechanical Testing	Based on FDA's June 12, 2007 "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" and specific ASTM standards:	"demonstrated substantially equivalent performance to the identified predicate devices." Specific tests performed include: - Static Compression (per ASTM F2077) - Dynamic Compression (per ASTM F2077) - Static Compression Shear (per ASTM F2077) - Dynamic Compression Shear (per ASTM F2077) - Static Torsion (per ASTM F2077) - Dynamic Torsion (per ASTM F2077) - Expulsion (per ASTM F04-25-02-02 Draft) - Subsidence (per ASTM F2267) - Wear Debris Assessment - Impaction
Material Properties	FDA guidance documents: - "Guidance Document for testing orthopedic implants with modified metallic surfaces apposing bone or bone cement [April 28, 1994]" - "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses [January 16, 2003]" - Draft guidance for "Technical considerations for Additive Manufactured Devices [May 10, 2016]" ASTM Standard: - ASTM 1472-08: Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy (UNS R56400) for Surgical Implant Applications	"established that the porous surface design of the cage meets at minimum the requirements outlined in the [referenced FDA guidance documents and ASTM standard]."
Material Mechanical Properties	ASTM standards: - ASTM F1147-05: Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings - ASTM F1044-05: Standard Test Method for Shear Testing of Calcium Phosphate and Metallic Coatings - ASTM F1160-05: Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coating - ASTM E8/E8M: Standard Test Methods for Tension Testing of Metallic Materials	Characterization of the Mechanical Properties of the Tritanium® C Anterior Cervical Cage material was performed in accordance with these standards. The conclusion states "results of the mechanical testing... demonstrated substantial equivalence."
Corrosion Susceptibility	ASTM F2129-15: Standard test method for conducting cyclic potentiodynamic polarization measurements to determine the corrosion susceptibility of small implant devices.	"Electromechanical performance evaluation of additive manufactured Ti-6Al-4V alloy was also performed per ASTM F2129-15." The overall conclusion implies satisfactory performance.
Pyrogenicity	ANSI/AAMI ST72:2011: For bacterial endotoxin testing (BET) to achieve an endotoxin limit of < 20 EU/Device.	"Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 is used for pyrogenicity testing to achieve the Endotoxin limit of < 20EU/Device." The overall conclusion implies satisfactory performance.

2. Sample Size Used for the Test Set and Data Provenance

This document describes non-clinical (bench) testing, not a clinical trial with a "test set" of patient data. Therefore, the concepts of human "sample size" and "data provenance" (country, retrospective/prospective) are not applicable in this context. The testing was performed on representative units of the medical device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is a non-clinical device safety and performance evaluation. "Ground truth" in the context of human expert consensus is not applicable. The "ground truth" for this type of evaluation is defined by adherence to established engineering standards (ASTM) and FDA guidance documents. The expertise involved would be in manufacturing, materials science, and biomechanical engineering, typically internal or external testing labs, but not clinical "experts" establishing ground truth in the sense of medical diagnosis.

4. Adjudication Method for the Test Set

As this is non-clinical bench testing, an "adjudication method" involving human readers or experts in the clinical sense is not applicable. The results are objectively measured against predefined criteria from the standards and guidance documents.

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

An MRMC study is relevant for imaging or diagnostic AI devices. This document is for an intervertebral body fusion device (an implant). Therefore, an MRMC comparative effectiveness study is not applicable. There is no AI component mentioned in the context of this device.

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

This device does not have an "algorithm only" or "human-in-the-loop" component in the sense of a diagnostic or AI-powered device. The device itself is an implant. Standalone performance refers to the device's mechanical and material properties as tested on a bench. All the performance data described (demonstrated substantially equivalent performance) represents the standalone performance of the physical device.

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

For this non-clinical submission, the "ground truth" is based on:

Engineering Standards: Specific ASTM standards (e.g., F2077, F2267, F1147, F1044, F1160, E8/E8M, F2129-15). These standards define test methodologies and often include performance benchmarks or criteria for material properties and mechanical performance.
FDA Guidance Documents: Such as the "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" and guidance related to modified metallic surfaces and additive manufactured devices. These documents outline the expected performance characteristics and testing requirements for this type of device.
Predicate Device Performance: The primary "ground truth" for substantial equivalence is the demonstrated performance of legally marketed predicate devices. The new device's performance is compared to these established benchmarks to show it is "substantially equivalent" and thus equally safe and effective.

8. The Sample Size for the Training Set

This document describes non-clinical testing for a physical implant, not an AI/machine learning device that would require a "training set." Therefore, the concept of a training set sample size is not applicable.

9. How the Ground Truth for the Training Set was Established

Since there is no "training set" for an AI algorithm in this context, the method for establishing its "ground truth" is not applicable.

Summary

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

September 6, 2017

Image /page/0/Picture/4 description: The image shows the logo for the Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other.

Stryker Spine Deborah Cynamon Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401

Re: K171496

Trade/Device Name: Tritanium® C Anterior Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: August 4, 2017 Received: August 7, 2017

Dear Ms. Cynamon:

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 Part 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 (DICE) 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 (DICE) 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,

Katherine D. Kavlock -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K171496

Device Name Tritanium® C Anterior Cervical Cage

Indications for Use (Describe)

The Tritanium® C Anterior Cervical Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.

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)

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510(k) Summary as required by 21 CFR §807.92(c).
Tritanium® C Anterior Cervical Cage
	Stryker Spine
Submitted by	2 Pearl Court
	Allendale, New Jersey 07401
	Deborah Cynamon
Contact Person	Regulatory Affairs Specialist
	Phone: 201 749 8388
	Email: Deborah.cynamon@stryker.com
Date Prepared	September 6, 2017
Common Name	Intervertebral body fusion device
Trade Name	Tritanium® C Anterior Cervical Cage
Proposed Class	Class II
Classification Nameand Number	Intervertebral body fusion device, 21 CFR §888.3080
Product Code	ODP
Predicate Devices	Legally marketed predicate devices to which substantialequivalence is claimed:
	Primary predicate:●Stryker Spine AVS® AS Peek Spacers (K142251)
	Additional Predicates:●
	Orthovita Peek Spacer (K101171)
	Amendia Interbody Fusion Multi-level Cervical (K160924)
	Stryker Spine AERO® - C Cage System (K152532)
	Stryker Spine Tritanium® PL Cage (K152304, K162262)
Device Description	The Stryker Spine Tritanium® C Anterior Cervical Cage is ahollow, ring shaped titanium alloy (Ti-6Al-4V) interbody fusioncage intended for use in the cervical spine. The cage consists ofan open window for bone graft containment and has serrationson the superior and inferior surfaces of the cage for fixation.The cage is offered in a variety of footprints, heights, andlordotic angles to adapt to varying patient anatomies. TheTritanium® C Anterior Cervical Cage consists of a uniqueconfiguration of both solid and porous structures that aresimultaneously built using Laser Rapid Manufacturing (LRM)method applying Stryker's proprietary Tritanium® In-GrowthTechnology. The Tritanium® C Anterior Cervical Cage isprovided sterile.
Intended Use andIndications for Use	The Stryker Spine Tritanium® C Anterior Cervical Cage isindicated for use in cervical interbody fusion procedures inskeletally mature patients with degenerative disc disease (DDD)at one level or two contiguous levels from the C2 to T1 disc.
510(k) Summary as required by 21 CFR §807.92(c).Tritanium® C Anterior Cervical Cage
DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy.
The Tritanium® C Anterior Cervical Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.
The Tritanium® C Anterior Cervical Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.
Summary of theTechnologicalCharacteristics	The subject Tritanium® C Anterior Cervical Cage and the predicates share similar design features:Graft windows for packing autogenous or allogenic bone Comparable heights, widths, depths, and lordotic angles Serrations on the superior and inferior surfaces Supplemental fixation
Summary ofNon-Clinical Testing	Testing in compliance with:FDA's June 12, 2007 “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" was performed for the Tritanium® C Anterior Cervical Cage and demonstrated substantially equivalent performance to the identified predicate devices.The following mechanical tests were performed: Static Compression (per ASTM F2077) Dynamic Compression (per ASTM F2077) Static Compression Shear (per ASTM F2077) Dynamic Compression Shear (per ASTM F2077) Static Torsion (per ASTM F2077) Dynamic Torsion (per ASTM F2077) Expulsion (per ASTM F04-25-02-02 Draft) Subsidence (per ASTM F2267) Wear Debris Assessment Impaction Characterization of the Physical Properties and Chemistry of theTritanium® C Anterior Cervical Cage material testing
510(k) Summary as required by 21 CFR §807.92(c).Tritanium® C Anterior Cervical Cage	established that the porous surface design of the cage meets at minimum the requirements outlined in the:FDA guidance documents: “Guidance Document for testing orthopedic implants with modified metallic surfaces apposing bone or bone cement [April 28, 1994]”, “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses [January 16, 2003]”, and draft guidance for “Technical considerations for Additive Manufactured Devices [May 10, 2016]” ASTM 1472-08: Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy (UNS R56400) for Surgical Implant Applications Characterization of the Mechanical Properties of the Tritanium® C Anterior Cervical Cage material was performed in accordance with the following standards:ASTM F1147-05: Standard Test Method for Tension Testing of Calcium Phosphate and Metallic CoatingsASTM F1044-05: Standard Test Method for Shear Testing of Calcium Phosphate and Metallic CoatingsASTM F1160-05: Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic CoatingASTM E8/E8M: Standard Test Methods for Tension Testing of Metallic MaterialsElectromechanical performance evaluation of additive manufactured Ti-6Al-4V alloy was also performed per ASTM F2129-15: Standard test method for conducting cyclic potentiodynamic polarization measurements to determine the corrosion susceptibility of small implant devices.Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 is used for pyrogenicity testing to achieve the
510(k) Summary as required by 21 CFR §807.92(c).
Tritanium® C Anterior Cervical Cage
	Endotoxin limit of < 20EU/Device.
Conclusion	Based on the design features, the use of established well knownmaterials, feature comparisons, indications for use, and results ofthe mechanical testing, the Tritanium® C Anterior Cervical Cagehas demonstrated substantial equivalence to the identifiedpredicate devices.

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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.