(37 days)
Not Found
No
The document describes a mechanical, expandable interbody fusion device and does not mention any software, algorithms, or AI/ML capabilities. The focus is on the physical characteristics and mechanical testing of the implant.
Yes
The device is intended for intervertebral body fusion to treat degenerative disc disease and degenerative scoliosis, which are therapeutic medical conditions.
No
The provided text describes the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage as intervertebral body fusion devices, which are implants used in surgery to treat degenerative disc disease and scoliosis. The device is used as an "adjunct to fusion," meaning it aids in the fusion process, rather than diagnosing a condition. Its function is to facilitate stability and fusion of vertebrae after diagnosis has already been made, typically confirmed by history and radiographic studies.
No
The device description clearly states it is a physical, expandable interbody fusion device made of Tritanium, intended for surgical implantation. It describes mechanical testing and physical dimensions, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device description: The description clearly states that the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are implantable devices intended for intervertebral body fusion. They are surgically placed within the body.
- Intended Use: The intended use describes treating degenerative disc disease and degenerative scoliosis by aiding in spinal fusion. This is a therapeutic intervention, not a diagnostic test performed on a specimen outside the body.
Therefore, this device falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
MAX
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.
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)
A risk review was conducted on existing verification and validation data for the Tritanium X system relative to the addition of the 8mm implant. The results of this risk review indicated that there would be no impacts to safety or effectiveness of the system by including this device.
The following mechanical tests were performed:
• Subsidence testing conducted per ASTM F2267-04(2018)
• Impaction testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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
1
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)
Device Name
Tritanium® X TL Expandable, Curved, Posterior Lumbar Cage
Indications for Use (Describe)
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.
| 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 Spine
2 Pearl Ct.
Allendale, NJ 07401 |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person : | Name: Jamie Wilson, RAC
Phone: 832-498-6935
Email: 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® X
TL Expandable Curved Posterior Lumbar Cage (K183249) |
| 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. |
| Indications for Use: | 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 of discogenic origin 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 and/or corticocancellous bone graft when the
subject device is used as an adjunct to fusion. |
| Summary of the
Technological
Characteristics | 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. |
| Summary of the
Performance Data | A risk review was conducted on existing verification and validation data for the
Tritanium X system relative to the addition of the 8mm implant. The results of
this risk review indicated that there would be no impacts to safety or
effectiveness 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 mechanical
testing, the Tritanium® X TL Expandable Curved Posterior Lumbar Cage has
demonstrated substantial equivalence to the identified predicate devices. |
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