The Stryker Spine Tritanium® PL Cage is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when 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 of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the Tritanium® PL Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The Tritanium® PL Cage is to be implanted via a posterior approach.

The Tritanium® PL Cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

Device Description

The purpose of this submission is to introduce new implant sizes to the previously cleared Tritanium® PL Cage offering. The Tritanium® PL Intervertebral Body Fusion Cage is intended for use as an aid in lumbar spinal fixation. The cage is a hollow, rectangular implant that 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 cage is offered in a variety of lengths, heights, widths and lordotic angles to adapt to a variety of patient anatomies. It has serrations on the superior and inferior porous surfaces of the implant for fixation, an ergonomically shaped anterior edge, and a flat posterior edge. The implant is designed to be used with supplemental fixation cleared for use in the lumbosacral spine. The Tritanium® PL cages are constructed from Titanium alloy: Ti-6Al-4V (ASTM F1472-08) and are provided sterile.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the Stryker Spine Tritanium® PL Cage. It describes the device, its intended use, and claims substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in the form of numerical thresholds for performance. Instead, the "acceptance criteria" are implied by the requirement to demonstrate "substantially equivalent performance" to predicate devices through various mechanical tests. The reported device performance is that it met the requirements of these tests.

Acceptance Criterion (Implied)	Reported Device Performance
Substantially equivalent performance to predicate devices (K160955, K151726) per FDA's June 12, 2007 "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device".	Testing performed on the subject Tritanium® PL Cages demonstrated substantially equivalent performance to the identified predicate devices in compliance with the FDA guidance document.
Static and Dynamic Compression (per ASTM F2077)	Performed
Static and Dynamic Compression Shear (per ASTM F2077)	Performed
Static and Dynamic Torsion (per ASTM F2077)	Performed
Expulsion (per ASTM F04-25-02-02 Draft)	Performed
Subsidence (per ASTM F2267)	Performed
Wear Debris Assessment	Performed
Impaction	Performed
Endotoxin limit of < 20EU/Device (per ANSI/AAMI ST72:2011)	Bacterial endotoxin testing (BET) was used to achieve the specified endotoxin limit.

Sample size used for the test set and the data provenance:

The document refers to mechanical testing rather than clinical or performance data involving human subjects. Therefore, the concept of a "test set" in the context of clinical data provenance (country of origin, retrospective/prospective) is not applicable here. The "test set" for this submission would be the physical Tritanium® PL Cages manufactured for mechanical evaluation. The specific number of devices tested for each mechanical test (e.g., how many cages were subjected to compression) is not provided in this summary but would be detailed in the full test reports.

Data provenance: Not applicable in the context of human data. The tests are laboratory-based mechanical tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable. "Ground truth" in this context typically refers to clinical diagnosis or outcome, which is not being assessed in this submission. The "truth" for mechanical testing is derived from the testing standards (ASTM, ANSI/AAMI) and the measured physical properties of the device compared to predicate devices. The expertise involved would be in engineering and materials science, not clinical diagnosis.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This question is not applicable as there is no clinical "test set" involving expert review or adjudication of results. The mechanical tests adhere to standardized protocols.
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:

This question is not applicable. The device is an intervertebral body fusion cage, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study or AI-related assessment is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This question is not applicable. The device is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the mechanical testing is based on established engineering principles, industry standards (ASTM, ANSI/AAMI), and comparison to the performance of predicate devices that have been deemed safe and effective. It's about meeting physical and material specifications, not a clinical "ground truth" derived from patient-specific data.
The sample size for the training set:

This question is not applicable. There is no mention of a "training set" as this is a physical medical device, not a machine learning model.
How the ground truth for the training set was established:

This question is not applicable, as there is no training set mentioned or implied.

Summary

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

November 9, 2016

Stryker Spine Ms. Deirdre Jayko Regulatory Affairs Associate 2 Pearl Court Allendale, New Jersey 07401

Re: K162262

Trade/Device Name: Tritanium® PL Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 10, 2016 Received: August 11, 2016

Dear Ms. Jayko:

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 devicerelated 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.

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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,

Lori A. Wiggins -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) K162262

Device Name Tritanium® PL Cage

Indications for Use (Describe)

Additionally, the Tritanium® PL Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The Tritanium® PL Cage is to be implanted via a posterior approach.

The Tritanium® PL Cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral 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® PL Cage
Submitted by	Stryker Spine2 Pearl CourtAllendale, New Jersey 07401
Contact Person	Deirdre JaykoRegulatory Affairs AssociatePhone: 201-749-8339Email: deirdre.jayko@stryker.com
Date Prepared	November 4, 2016
Common Name	Intervertebral body fusion device
Trade Name	Tritanium® PL Cage
Proposed Class	Class II
Classification Nameand Number	Intervertebral body fusion device, 21 CFR §888.3080
Product Code	MAX: Intervertebral Body Fusion Device with Bone Graft, Lumbar
Predicate Devices	Legally marketed predicate devices to which substantialequivalence is claimed:Primary predicate:Stryker Spine Tritanium ® PL (K160955) Additional predicates:Stryker Spine AVS® PL and AVS® UniLIF™ (K151726)Stryker Spine AVS® ALign (K151726)
Device Description	The purpose of this submission is to introduce new implant sizesto the previously cleared Tritanium® PL Cage offering.The Tritanium® PL Intervertebral Body Fusion Cage is intendedfor use as an aid in lumbar spinal fixation. The cage is a hollow,rectangular implant that consists of a unique configuration of bothsolid and porous structures that are simultaneously built usingLaser Rapid Manufacturing (LRM) method applying Stryker'sproprietary Tritanium® In-Growth Technology. The cage isoffered in a variety of lengths, heights, widths and lordotic anglesto adapt to a variety of patient anatomies. It has serrations on thesuperior and inferior porous surfaces of the implant for fixation,an ergonomically shaped anterior edge, and a flat posterior edge.The implant is designed to be used with supplemental fixationcleared for use in the lumbosacral spine.The Tritanium® PL cages are constructed from Titanium alloy: Ti-6Al-4V (ASTM F1472-08) and are provided sterile.
Intended Use andIndications for Use	The Stryker Spine Tritanium® PL cage is an intervertebral bodyfusion device indicated for use with autograft and/or allogenicbone graft comprised of cancellous and/or corticocancellous bonegraft when used as an adjunct to fusion in patients withdegenerative disc disease (DDD) at one level or two contiguouslevels from L2 to S1.DDD is defined as back pain of discogenic origin with degeneration
510(k) Summary as required by 21 CFR §807.92(c).Tritanium® PL Cage
	of the disc confirmed by history and radiographic studies. TheDDD patients may also have up to Grade I spondylolisthesis at theinvolved level(s). These patients should be skeletally mature andhave six months of nonoperative therapy.Additionally, the Tritanium® PL Cage can be used as an adjunct tofusion in patients diagnosed with degenerative scoliosis.The Tritanium® PL Cage is to be implanted via a posteriorapproach.The Tritanium® PL Cage is intended to be used with supplementalspinal fixation systems that have been cleared for use in thelumbosacral spine.
Summary of theTechnologicalCharacteristics	The subject Tritanium® PL Cages share the same materials, designcharacteristics, and fundamental scientific technologies as thepredicate Tritanium® PL Cages. The purpose of this submission isto introduce new implant sizes to the previously clearedTritanium® PL Cages offering. The subject devices and thepredicates share similar design features:• Graft windows for packing autogenous bone• Serrations on the superior and inferior surfaces• Comparable heights, widths, depths, lordotic angles, andmaterial
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 subjectTritanium® PL Cages and demonstrated substantially equivalentperformance to the identified predicate devices.The following mechanical tests were performed:• Static and Dynamic Compression (per ASTM F2077)• Static and Dynamic Compression Shear (per ASTM F2077)• Static and Dynamic Torsion (per ASTM F2077)• Expulsion (per ASTM F04-25-02-02 Draft)• Subsidence (per ASTM F2267)• Wear Debris Assessment, and• ImpactionBacterial endotoxin testing (BET) as specified in ANSI/AAMIST72:2011 is used for pyrogenicity testing to achieve theEndotoxin 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 subject Tritanium® PL Cages havedemonstrated substantial equivalence to the identified predicatedevices.

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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.