(92 days)
Tritanium® PL Cage (K160955)
N/A
No
The document describes a physical implant (intervertebral body fusion cage) and its manufacturing process. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
Explanation: The device is an intervertebral body fusion device used to treat degenerative disc disease and degenerative scoliosis, which are medical conditions, and it is implanted into the body as an adjunct to fusion, making it a therapeutic device.
No
The device is an intervertebral body fusion device intended to aid in spinal fixation, not to diagnose medical conditions.
No
The device description clearly states it is a physical implant (cage) constructed from titanium alloy, not software.
Based on the provided information, the Stryker Spine Tritanium® PL Cage is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The description of the Tritanium® PL Cage clearly states it is an implantable device used for spinal fusion. It is surgically placed within the body to aid in the fusion of vertebrae.
- The intended use and device description focus on the structural and mechanical properties of the implant for supporting spinal fusion. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
Therefore, the Tritanium® PL Cage falls under the category of an implantable medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MAX
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 footprints 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1
Indicated Patient Age Range
skeletally mature
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Stryker Spine Tritanium® PL Cage, with the incorporation of the proposed design changes, has demonstrated substantial equivalence to the predicate device. The Engineering Analysis, which included two FEAs, has demonstrated that the proposed design changes do not adversely affect the performance of the Tritanium® PL Cage and do not represent a new, worst case scenario in any of the test methods presented in the predicate submission including:
• Static and Dynamic Compression Shear (per ASTM F2077-14)
• Static and Dynamic Torsion (per ASTM F2077-14)
• Static and Dynamic Compression (per ASTM F2077-14)
• Subsidence (per ASTM F2267-04)
• Expulsion (per ASTMF04-25-02-02 (Draft)-2000)
• Wear Debris Analysis
• Impaction
No additional performance data is provided as part of this submission.
Verification and validation activities demonstrated that all relevant acceptance criteria were met. The modified device is substantially equivalent to the predicate Tritanium PL® Cage.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Tritanium® PL Cage (K160955)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
N/A
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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July 18, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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 Spine Mr. Travis Catania Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
Re: K181014
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 18, 2018 Received: May 21, 2018
Dear Mr. Catania:
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 (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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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 comprehensive regulatory information about mediation-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,
Brent Showalter -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)
Device Name Tritanium® PL Cage
Indications for Use (Describe)
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.
| 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® PL Cage | |
|---|---|
| Submitter: | Stryker Spine |
| 2 Pearl Court | |
| Allendale, NJ 07401 | |
| Contact Person : | Name: Travis Catania |
| Phone: (201) 749-8038 | |
| Fax: (201) 962-4070 | |
| Email: Travis.Catania@stryker.com | |
| Date Prepared: | 5/23/2018 |
| Trade Name: | Tritanium® PL Cage |
| Common Name: | Intervertebral body fusion device |
| Proposed Class: | Class II |
| Classification Name: | Intervertebral Body Fusion Device (21 CFR §888.3080) |
| Product Code: | MAX: Intervertebral Body Fusion Device with Bone Graft, Lumbar |
| Predicate Devices: | Primary Predicate: |
| Tritanium® PL Cage(K160955) | |
| Predicate Devices: | Additional Predicates: |
| N/A | |
| Predicate Devices: | Reference Devices: |
| N/A | |
| 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 footprints 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. | |
| 510(k) Summary: Tritanium® PL Cage | |
| Intended Use: | 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. | |
| Summary of the | |
| Technological | |
| Characteristics | The subject Tritanium® PL Cage shares the same materials, fundamental |
| scientific technologies, and design characteristics as the predicate | |
| Tritanium® PL Cages. The purpose of this submission is to introduce and | |
| summarize the proposed design changes to the Tritanium® PL Cages, which | |
| retain the previously FDA cleared indications / intended use and mode of | |
| operation as presented in the previous 510(k) submission, K160955. | |
| Summary of the | |
| Performance Data | The Stryker Spine Tritanium® PL Cage, with the incorporation of the proposed |
| design changes, has demonstrated substantial equivalence to the predicate | |
| device. The Engineering Analysis, which included two FEAs, has demonstrated | |
| that the proposed design changes do not adversely affect the performance of | |
| the Tritanium® PL Cage and do not represent a new, worst case scenario in any | |
| of the test methods presented in the predicate submission including: | |
| • Static and Dynamic Compression Shear (per ASTM F2077-14) | |
| • Static and Dynamic Torsion (per ASTM F2077-14) | |
| • Static and Dynamic Compression (per ASTM F2077-14) | |
| • Subsidence (per ASTM F2267-04) | |
| • Expulsion (per ASTMF04-25-02-02 (Draft)-2000) | |
| • Wear Debris Analysis | |
| • Impaction | |
| No additional performance data is provided as part of this submission. | |
| Conclusion | Verification and validation activities demonstrated that all relevant |
| acceptance criteria were met. The modified device is substantially equivalent | |
| to the predicate Tritanium PL® Cage. |
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