(246 days)
Not Found
No
The summary describes a physical implantable device for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an "Intervertebral Body Fusion Cage" intended for use "as an adjunct to fusion in patients with degenerative disc disease (DDD)" and "degenerative scoliosis." These uses indicate its role in treating medical conditions, which falls under the definition of a therapeutic device.
No
This device is an intervertebral body fusion cage, which is an implant used for surgical treatment, not for diagnosing medical conditions. The "Indications for Use" section clearly states its purpose as an "adjunct to fusion" in patients already diagnosed with degenerative disc disease or scoliosis.
No
The device description clearly states it is a physical implantable cage made of titanium alloy, stainless steel, and silicone rubber, intended for spinal fixation. It is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are implants intended for intervertebral body fusion in patients with degenerative disc disease and degenerative scoliosis. They are surgically placed within the body to aid in spinal fixation.
- No Mention of Specimen Analysis: The text does not mention any analysis of biological specimens or any diagnostic function performed outside of the body.
Therefore, this device is a surgical implant, not an In Vitro Diagnostic device.
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 autograff and/or allogenic bone graft comprised of cancellous and/or corticocancellous 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 expandable posterior lumbar cage intended for use as an aid in lumbar spinal fixation.
The expandable Tritanium® X PL Expandable Posterior Lumbar Cage and the Tritanium® X TL Expandable Curved Posterior Lumbar Cage (also referred to as Tritanium X Cages) are Intervertebral Body Fusion Cages intended for use as an aid in lumbar spinal fixation. The TL cages are crescent shaped, and the PL cages are straight shaped.
These cages consist 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 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 graft windows 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 X cages are constructed from Titanium alloy: Ti-6Al-4V (ASTM F1472-08), Stainless Steel: 316 LVM (ASTM F138-08), and Silicone Rubber, 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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Testing in compliance with: FDA's June 12, 2007 "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" was performed for the subject Tritanium X Cages and demonstrated substantially equivalent performance 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
- Subsidence (per ASTM F2267-04)
- Wear Debris Assessment
- Impaction
Characterization of the Physical, Chemical, and Mechanical properties of the subject Tritanium X Cage was established through material testing which demonstrated that the porous surface design of the cage met, at minimum, the requirements outlined in the:
- FDA Guidance documents: "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement [April 28, 1994]", "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses [January 16, 2003]", and guidance for "Technical Considerations for Additive Manufactured Devices [December 5, 2017]"
- ASTM 1472-08: Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy (UNS R56400) for Surgical Implant Applications
- ASTM F1147-05: Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
- ASTM F1044-05: Standard Test Method for Shear Testing of Calcium Phosphate and Metallic Coatings
- ASTM F1160-05: Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coating
- ASTM E8/E8M: Standard Test Methods for Tension Testing of Metallic Materials
Electromechanical performance evaluation of additive manufactured Ti-6Al-4V alloy was also performed per ASTM F2129-15: Standard test method for conducting cyclic potentiodynamic polarization measurements to determine the corrosion susceptibility of small implant devices.
Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 is used for pyrogenicity testing to achieve the Endotoxin limit of
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
July 25, 2019
Stryker Spine Deirdre Jayko Senior Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
Re: K183249
Trade/Device Name: Tritanium® X PL Expandable Posterior Lumbar Cage, 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: July 3, 2019 Received: July 5, 2019
Dear Deirdre 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. 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
1
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 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 Melissa Hall, M.S. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K183249
Device Name
Tritanium® X PL Expandable Posterior Lumbar Cage and 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 autograff and/or allogenic bone graft comprised of cancellous and/or corticocancellous 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) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
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| 510(k) Summary: Tritanium® X PL Expandable Posterior Lumbar Cage &
| Tritanium® X TL Expandable Curved Posterior Lumbar Cage | |
|---|---|
| Manufacturer/Submitter: | Stryker Spine |
| 2 Pearl Ct. | |
| Allendale, NJ 07401 | |
| Contact Person : | Name: Deirdre Jayko |
| Phone: (201) 749-8339 | |
| Email: deirdre.jayko@stryker.com | |
| Date Prepared: | 11/20/2018 |
| Trade Name: | Tritanium® X PL Expandable Posterior Lumbar Cage |
| Tritanium® X TL Expandable 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 Spacers (K151726) | |
| Additional Predicates: | |
| Tritanium® PL Posterior Lumbar Cage (K181014) | |
| Tritanium® TL Posterior Curved Lumbar Cage (K173476) | |
| Globus Rise® Spacers (K171848) | |
| Device Description: | The purpose of this submission is to introduce an expandable posterior lumbar cage intended for use as an aid in lumbar spinal fixation. |
The expandable Tritanium® X PL Expandable Posterior Lumbar Cage and the Tritanium® X TL Expandable Curved Posterior Lumbar Cage (also referred to as Tritanium X Cages) are Intervertebral Body Fusion Cages intended for use as an aid in lumbar spinal fixation. The TL cages are crescent shaped, and the PL cages are straight shaped.
These cages consist 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 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 graft windows spanning endplate to |
| 510(k) Summary: Tritanium® X PL Expandable Posterior Lumbar Cage & | |
| Tritanium® X TL Expandable Curved Posterior Lumbar Cage | |
| | 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 X cages are constructed from Titanium alloy: Ti-6Al-4V (ASTM F1472-08), Stainless Steel: 316 LVM (ASTM F138-08), and Silicone Rubber, and are provided sterile. |
| 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 devices share 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 Comparable heights, widths, lengths, and lordotic angles Serrations on the superior and inferior surfaces |
| 510(k) Summary: Tritanium® X PL Expandable Posterior Lumbar Cage &
Tritanium® X TL Expandable Curved Posterior Lumbar Cage | |
| Summary of the
Performance Data | Indicated for use with supplemental fixation Expandable in-situ Testing in compliance with:
FDA's June 12, 2007 "Class II Special Controls Guidance Document:
Intervertebral Body Fusion Device" was performed for the subject Tritanium X Cages and demonstrated substantially equivalent performance 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 Subsidence (per ASTM F2267-04) Wear Debris Assessment Impaction Characterization of the Physical, Chemical, and Mechanical properties of the subject Tritanium X Cage was established through material testing which demonstrated that the porous surface design of the cage met, at minimum, the requirements outlined in the: FDA Guidance documents: "Guidance Document for Testing
Orthopedic Implants with Modified Metallic Surfaces Apposing Bone
or Bone Cement [April 28, 1994]", "Class II Special Controls Guidance
Document: Knee Joint Patellofemorotibial and Femorotibial
Metal/Polymer Porous-Coated Uncemented Prostheses [January 16,
2003]", and guidance for "Technical Considerations for Additive
Manufactured Devices [December 5, 2017]" ASTM 1472-08: Standard Specification for Wrought Titanium-
6Aluminum-4Vanadium Alloy (UNS R56400) for Surgical Implant
Applications ASTM F1147-05: Standard Test Method for Tension Testing of
Calcium Phosphate and Metallic Coatings ASTM F1044-05: Standard Test Method for Shear Testing of Calcium
Phosphate and Metallic Coatings ASTM F1160-05: Standard Test Method for Shear and Bending
Fatigue Testing of Calcium Phosphate and Metallic Medical and
Composite Calcium Phosphate/Metallic Coating ASTM E8/E8M: Standard Test Methods for Tension Testing of Metallic
Materials |
| 510(k) Summary: Tritanium® X PL Expandable Posterior Lumbar Cage &
Tritanium® X TL Expandable Curved Posterior Lumbar Cage | |
| | Electromechanical performance evaluation of additive manufactured Ti-6Al-
4V alloy was also performed per ASTM F2129-15: Standard test method for
conducting cyclic potentiodynamic polarization measurements to determine
the corrosion susceptibility of small implant devices.
Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 is
used for pyrogenicity testing to achieve the Endotoxin limit of