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 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 the Stryker Spine Tritanium® PL Cage. It describes the device, its intended use, and argues for its substantial equivalence to a previously cleared predicate device.

Based on the provided text, the device in question is a medical implant (an intervertebral body fusion device), not an AI/ML-enabled medical device that would typically undergo the kind of performance studies and establish acceptance criteria outlined in your request. The document discusses mechanical properties, material, and manufacturing processes, but it does not mention any AI algorithms or software components.

Therefore, the requested information regarding acceptance criteria and a study proving device performance (including sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not available in this specific document, as those types of studies are not relevant for this kind of physical medical device.

In summary, this document does not contain the information needed to answer your questions because it pertains to a traditional physical medical device, not an AI/ML-enabled medical device.

Summary

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

July 21, 2019

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

Re: K160955

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: May 2, 2016 Received: May 3, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the

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Page 2 – Ms. Deirdre Jayko

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 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,

Mark N. Melkerson -S

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

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

K160955 Page 1 of 1

510(k) Number (if known)

к160955

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)
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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	June 30, 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 predicateStryker Spine Tritanium® PL Cage (K152304)
Device Description	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 ofboth solid and porous structures that are simultaneously builtusing Laser Rapid Manufacturing (LRM) method applyingStryker's proprietary Tritanium® In-Growth Technology. Thecage is offered in a variety of lengths, heights, widths andlordotic angles to adapt to a variety of patient anatomies. It hasserrations on the superior and inferior porous surfaces of theimplant for fixation, an ergonomically shaped anterior edge, anda 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 corticocancellousbone graft 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 withdegeneration of the disc confirmed by history and radiographic
510(k) Summary as required by 21 CFR §807.92(c).
Tritanium® PL Cage
	studies. The DDD patients may also have up to Grade Ispondylolisthesis at the involved level(s). These patients shouldbe skeletally mature and have six months of nonoperativetherapy.Additionally, the Tritanium® PL Cage can be used as an adjunctto fusion 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 withsupplemental spinal fixation systems that have been cleared foruse in the lumbosacral spine.
Summary of theTechnologicalCharacteristics	The subject Tritanium® PL Cage shares identical materials,design features, and fundamental scientific technologies as thepredicate Tritanium® PL Cage.
Summary ofNon-Clinical Testing	The scope of this Traditional 510(k) submission includes devicemodifications for the Tritanium® PL Cages which werepreviously cleared under K152304.
	Bacterial endotoxin testing (BET) as specified in ANSI/AAMIST72:2011 is used for pyrogenicity testing to achieve theEndotoxin limit of < 20EU/Device.
	As there is no change in fit, form, or function of the devicecompared with the Tritanium® PL Cage previously clearedunder K152304, no additional mechanical testing wasperformed. No validation or verification data is presented in thissubmission.
Conclusion	The Tritanium® PL Cage is identical to the previously clearedpredicate Tritanium® PL Cage with respect to design features,intended use/indications for use, technological characteristics,material, and basic principles of operation. The purpose of thissubmission is to provide a summary of device modifications forthe Tritanium® PL Cages which were previously cleared underK152304. These modifications have no impact on the form, fit, orfunction of the device as compared with the previously clearedTritanium® PL Cage. There is no change to intendeduse/indications for use. The modifications do not present anynew issues of safety or effectiveness.

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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.