(70 days)
The Stryker Spine Tritanium® TL 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 TL Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The Tritanium TL Cage is to be implanted via a posterior approach.
The Tritanium TL Cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
The purpose of this submission is to introduce a curved posterior lumbar cage intended for use as an aid in lumbar spinal fixation.
The Tritanium TL Intervertebral Body Fusion Cage is intended for use as an aid in lumbar spinal fixation. The cage is a curved 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 and lordotic angles to adapt to a variety of patient anatomies. It has serrations on the superior and inferior surfaces designed for multidirectional fixation and to maximize surface area for endplate contact with the implant. The implants have a smooth, tapered leading edge to facilitate cage insertion into the intervertebral space. The implants have a central column spanning endplate to endplate for graft containment and to aid in fusion throughout the interbody cage.
The implant is designed to be used with supplemental fixation cleared for use in the lumbosacral spine.
The Tritanium TL cages are constructed from Titanium alloy: Ti-6Al-4V (ASTM F1472-08) and are provided sterile.
The provided document is a 510(k) summary for the Stryker Tritanium® TL Curved Posterior Lumbar Cage, an intervertebral body fusion device. It details the device's characteristics and the testing performed to demonstrate substantial equivalence to predicate devices. However, this document does not describe the acceptance criteria, reported device performance, or details of a study on AI/algorithm performance for a medical imaging or diagnostic device.
The request asks for information relevant to AI-powered medical devices, such as sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, and standalone performance. None of this information is present in the provided text, as the document pertains to a physical orthopedic implant, not a software-based diagnostic tool.
Therefore, I cannot fulfill the request for information related to acceptance criteria and device performance in the context of AI/algorithm studies based on the provided text. The document describes mechanical and material testing for a physical implant, not an algorithm's performance.
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January 18, 2018
Stryker Mr. Nikin Desai Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
Re: K173476
Trade/Device Name: Tritanium® TL Curved Posterior Lumbar Cage Regulation Number: 21 CFR 888,3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: November 8, 2017 Received: November 9, 2017
Dear Mr. Desai:
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 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.
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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.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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) K173476
Device Name
Tritanium® TL Curved Posterior Lumbar Cage
Indications for Use (Describe)
The Stryker Spine Tritanium® TL 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 TL Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The Tritanium TL Cage is to be implanted via a posterior approach.
The Tritanium TL 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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stryker
| 510(k) Summary: Tritanium® TL Curved Posterior Lumbar Cage | |
|---|---|
| Manufacturer/Submitter: | Stryker Spine2 Pearl Ct.Allendale, NJ 07401 |
| Contact Person : | Name: Nikin DesaiPhone: (201) 749-8176Fax: (201) 831-3000Email:Nikin.Desai@stryker.com |
| Date Prepared: | 11/08/2017 |
| Trade Name: | Tritanium® TL Curved Posterior Lumbar Cage |
| Common Name: | Intervertebral body fusion device |
| Proposed Class: | Class II |
| Classification Name: | Intervertebral Body Fusion Device with Bone Graft, Lumbar (21 CFR§888.3080) |
| Product Code: | MAX |
| Predicate Devices: | Primary Predicates:AVS® PL and TL PEEK Spacers (K151726)Additional Predicates:Tritanium® PL Posterior Lumbar Cage (K162262)Tritanium® C Anterior Cervical Cage (K171496) |
| Device Description: | The purpose of this submission is to introduce a curved posterior lumbarcage intended for use as an aid in lumbar spinal fixation.The Tritanium TL Intervertebral Body Fusion Cage is intended for use as anaid in lumbar spinal fixation. The cage is a curved implant that consists of aunique configuration of both solid and porous structures that aresimultaneously built using Laser Rapid Manufacturing (LRM) methodapplying Stryker's proprietary Tritanium® In-Growth Technology. The cageis offered in a variety of lengths, heights and lordotic angles to adapt to avariety of patient anatomies. It has serrations on the superior and inferiorsurfaces designed for multidirectional fixation and to maximize surface areafor endplate contact with the implant. The implants have a smooth, taperedleading edge to facilitate cage insertion into the intervertebral space. Theimplants have a central column spanning endplate to endplate for graftcontainment and to aid in fusion throughout the interbody cage.The implant is designed to be used with supplemental fixation cleared for usein the lumbosacral spine.The Tritanium TL cages are constructed from Titanium alloy: Ti-6Al-4V(ASTM F1472-08) and are provided sterile. |
| 510(k) Summary: Tritanium® TL Curved Posterior Lumbar Cage | |
| Indications for Use: | The Stryker Spine Tritanium® TL cage is an intervertebral body fusion deviceindicated for use with autograft and/or allogenic bone graft comprised ofcancellous and/or corticocancellous bone graft when used as an adjunct tofusion in patients with degenerative disc disease (DDD) at one level or twocontiguous levels from L2 to S1.DDD is defined as back pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies. The DDD patients may alsohave up to Grade I spondylolisthesis at the involved level(s). These patientsshould be skeletally mature and have six months of nonoperative therapy.Additionally, the Tritanium TL Cage can be used as an adjunct to fusion inpatients diagnosed with degenerative scoliosis.The Tritanium TL Cage is to be implanted via a posterior approach.The Tritanium TL Cage is intended to be used with supplemental spinalfixation systems that have been cleared for use in the lumbosacral spine. |
| Summary of theTechnologicalCharacteristics | The Subject Tritanium TL Curved Posterior Lumbar Cage and the clearedTritanium PL and C cages share similar material/material technology andthe following design features:Graft windows for packing autogenous or allogenic bone Comparable heights, widths, lengths and lordotic angles Serrations on the superior and inferior surfaces Supplemental fixation |
| Summary of thePerformance Data | Testing in compliance with:FDA's June 12, 2007 "Class II Special Controls Guidance Document:Intervertebral Body Fusion Device" was performed for the subject TritaniumTL Cages and demonstrated substantially equivalent performance to theidentified predicate devices. The following mechanical tests were performed:Static and Dynamic Compression (per ASTM F2077-14) Static and Dynamic Compression Shear (per ASTM F2077-14) Static and Dynamic Torsion (per ASTM F2077-14) Expulsion (per ASTM F04-25-02-02 Draft) Subsidence (per ASTM F2267-04(2011)) Wear Debris Assessment, and ImpactionCharacterization of the Physical, Chemistry and Mechanical properties of thesubject Tritanium TL Curved Posterior Lumbar Cage was established through |
| 510(k) Summary: Tritanium® TL Curved Posterior Lumbar Cage | |
| Tritanium C Anterior Cervical Cage material testing which demonstrated thatthe porous surface design of the cage met at minimum the requirementsoutlined in the:FDA guidance documents: "Guidance Document for testing orthopedicimplants with modified metallic surfaces apposing bone or bonecement [April 28, 1994]", "Class II Special Controls GuidanceDocument: Knee Joint Patellofemorotibial and FemorotibialMetal/Polymer Porous-Coated Uncemented Prostheses [January 16,2003]", and draft guidance for "Technical considerations for AdditiveManufactured Devices [May 10, 2016]" ASTM 1472-08: Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy (UNS R56400) for Surgical ImplantApplications ASTM F1147-05: Standard Test Method for Tension Testing ofCalcium Phosphate and Metallic Coatings ASTM F1044-05: Standard Test Method for Shear Testing of CalciumPhosphate and Metallic Coatings ASTM F1160-05: Standard Test Method for Shear and BendingFatigue Testing of Calcium Phosphate and Metallic Medical andComposite Calcium Phosphate/Metallic Coating ASTM E8/E8M: Standard Test Methods for Tension Testing of MetallicMaterials Electromechanical performance evaluation of additive manufactured Ti-6Al-4V alloy was also performed per ASTM F2129-15: Standard test method forconducting cyclic potentiodynamic polarization measurements to determinethe corrosion susceptibility of small implant devices.Bacterial 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 known materials,feature comparisons, indications for use, and results of the mechanicaltesting, the Tritanium TL Curved Posterior Lumbar Cage has demonstratedsubstantial equivalence to the identified predicate devices |
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stryker
§ 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.