The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are intended for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.

Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are always to be used with supplemental internal spinal fixation. Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are to be used with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion.

Device Description

The purpose of this submission is to introduce an additional cage size to the range of available Tritanium TL cages. The dimensions of the subject device are identical to the predicate TL cages (12mm width; 32mm length) but with a height of 8-10mm (based on expansion). The current range of Tritanium TL cages currently range in heights from 9-13mm.

The subject Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are hydraulically expandable interbody fusion devices. The subject device shares technological characteristics with the cited predicate devices and do not raise any new questions of safety and effectiveness. The below characteristics are shared between the subject and predicate devices:
• Graft windows for packing autogenous or allogenic bone
• Serrations on the superior and inferior surfaces
• Indicated for use with supplemental fixation
• Expandable in-situ

There are no changes to the fundamental technological characteristics of the identified predicate devices in this submission.

AI/ML Overview

This document is a 510(k) summary for the Tritanium® X TL Expandable Curved Posterior Lumbar Cage. It describes the device and its intended use, and importantly, references a study to demonstrate its substantial equivalence to a predicate device.

Here's an breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document summarizes the performance testing conducted, but it does not explicitly state specific acceptance criteria values. Instead, it indicates that a "risk review was conducted on existing verification and validation data for the Tritanium X system relative to the addition of the 8mm implant," and concludes that "there would be no impacts to safety or effectiveness of the system by including this device." The mechanical tests performed are listed as:

Acceptance Criteria (Not explicitly stated with numerical values in the provided text, but implied by regulatory standards for interbody fusion devices)	Reported Device Performance
Mechanical Performance (e.g., strength, stability, resilience under various loads as per relevant ASTM standards for intervertebral body fusion devices)	Subsidence testing: Conducted per ASTM F2267-04(2018). (Specific results not detailed, but implied to meet requirements for substantial equivalence.)
	Impaction testing: Performed. (Specific results not detailed, but implied to meet requirements for substantial equivalence.)
Safety and Effectiveness (Ensuring the additional implant size does not negatively impact the overall system's safety or effectiveness compared to the predicate)	A risk review was conducted which indicated "no impacts to safety or effectiveness of the system by including this device." The device is deemed substantially equivalent based on design, materials, feature comparisons, indications for use, and mechanical testing results.

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

Sample Size for Test Set: Not explicitly stated. The document mentions "existing verification and validation data" and "the addition of the 8mm implant" to the system. It's likely the "test set" refers to the specific 8mm implant size and its performance validation within the existing Tritanium X system, but the number of units or tests performed for this specific variant is not quantified.
Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be a benchtop (mechanical) study, not a clinical study with human subject data. Therefore, the applicability of "retrospective or prospective" is not directly relevant in the clinical sense, but the testing itself would have been prospective to demonstrate the performance of the new size.

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

This question is not applicable to the provided document. The study described is a mechanical performance study (subsidence and impaction testing) conducted on a medical device. It does not involve human readers, image interpretation, or the establishment of "ground truth" through expert consensus in a clinical or diagnostic context. The ground truth for mechanical testing is established by the specified ASTM standards and engineering principles.

4. Adjudication Method for the Test Set

Not applicable. As this is a mechanical performance study, there is no adjudication method in the sense of expert review or consensus for clinical data. The results are based on objective measurements from the mechanical tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This document describes mechanical bench testing of an intervertebral body fusion device, not an AI or diagnostic imaging device that would typically undergo MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI or algorithm-based device. The term "standalone performance" typically refers to the performance of an AI model without human interaction.

7. The Type of Ground Truth Used

The "ground truth" for this study is based on established mechanical engineering standards (ASTM F2267-04(2018) for subsidence testing) and the mechanical properties derived from the impaction testing. The performance is assessed against these predefined engineering and material science criteria, which serve as the "ground truth" for device safety and effectiveness in a mechanical context.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device, not a machine learning model, so there is no concept of a "training set."

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

Not applicable, as there is no training set for this device.

Summary

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April 15, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Stryker Corporation Jamie Wilson Sr. Staff Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401

Re: K200613

Trade/Device Name: Tritanium® X TL Expandable Curved Posterior Lumbar Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 19, 2020 Received: March 19, 2020

Dear Jamie Wilson:

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 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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Brent Showalter, Ph.D. Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K200613

Device Name

Tritanium® X TL Expandable, Curved, Posterior Lumbar Cage

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)

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510(k) Summary: Tritanium ® X TL Expandable, Curved, Posterior Lumbar Cage

Submitter:	Stryker Spine2 Pearl Ct.Allendale, NJ 07401
Contact Person :	Name: Jamie Wilson, RACPhone: 832-498-6935Email: Jamie.wilson1@stryker.com
Date Prepared:	March 19, 2020
Trade Name:	Tritanium® X TL Expandable Curved Posterior Lumbar Cage
Common Name:	Intervertebral body fusion device
Proposed Class:	Class II
Classification Name:	Intervertebral Fusion Device with Bone Graft, Lumbar (21 CFR §888.3080)
Product Code:	MAX
Predicate Devices:	Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® XTL Expandable Curved Posterior Lumbar Cage (K183249)
Device Description:	The purpose of this submission is to introduce an additional cage size to therange of available Tritanium TL cages. The dimensions of the subject deviceare identical to the predicate TL cages (12mm width; 32mm length) but witha height of 8-10mm (based on expansion). The current range of Tritanium TLcages currently range in heights from 9-13mm.
Indications for Use:	The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® XTL Expandable Curved Posterior Lumbar Cage are intended for intervertebralbody fusion with autograft and/or allogenic bone graft comprised ofcancellous and/or corticocancellous bone graft when the subject device isused as an adjunct to fusion in patients with degenerative disc disease (DDD)at one level or two contiguous levels from L2 to S1. DDD is defined as backpain of discogenic origin with degeneration of the disc confirmed by historyand radiographic studies. These DDD patients may also have up to Grade Ispondylolisthesis or retrolisthesis at the involved level(s). These patientsshould be skeletally mature and have completed six months of non-operativetreatment.Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage andTritanium® X TL Expandable Curved Posterior Lumbar Cage can be used asan adjunct to fusion in patients diagnosed with degenerative scoliosis.The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® XTL Expandable Curved Posterior Lumbar Cage are always to be used withsupplemental internal spinal fixation. Additionally, the Tritanium® X PLExpandable Posterior Lumbar Cage and Tritanium® X TL Expandable CurvedPosterior Lumbar Cage are to be used with autograft and/or allogenic bonegraft comprised of cancellous and/or corticocancellous bone graft when thesubject device is used as an adjunct to fusion.
Summary of theTechnologicalCharacteristics	The subject Tritanium® X PL Expandable Posterior Lumbar Cage andTritanium® X TL Expandable Curved Posterior Lumbar Cage arehydraulically expandable interbody fusion devices. The subject deviceshares technological characteristics with the cited predicate devices and donot raise any new questions of safety and effectiveness. The belowcharacteristics are shared between the subject and predicate devices:• Graft windows for packing autogenous or allogenic bone• Serrations on the superior and inferior surfaces• Indicated for use with supplemental fixation• Expandable in-situThere are no changes to the fundamental technological characteristics of theidentified predicate devices in this submission.
Summary of thePerformance Data	A risk review was conducted on existing verification and validation data for theTritanium X system relative to the addition of the 8mm implant. The results ofthis risk review indicated that there would be no impacts to safety oreffectiveness of the system by including this device.The following mechanical tests were performed:• Subsidence testing conducted per ASTM F2267-04(2018)• Impaction testing
Conclusion	Based on the design features, the use of established well known materials,feature comparisons, indications for use, and results of the mechanicaltesting, the Tritanium® X TL Expandable Curved Posterior Lumbar Cage hasdemonstrated substantial equivalence to the identified predicate devices.

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510(k) Summary: Tritanium ® X TL Expandable, Curved, Posterior Lumbar Cage

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.