(107 days)
No
The 510(k) summary describes a physical intervertebral body fusion device made of titanium alloy using a specific manufacturing process. There is no mention of software, algorithms, data processing, or any other elements typically associated with AI/ML technology. The performance studies focus on bacterial endotoxin testing and comparison to a predicate device based on fit, form, and function, not algorithmic performance.
Yes.
It is an intervertebral body fusion device used to treat degenerative disc disease and degenerative scoliosis, which are therapeutic interventions.
No
The device is an intervertebral body fusion device and is described as an "aid in lumbar spinal fixation." Its purpose is to physically assist fusion, not to diagnose medical conditions.
No
The device description clearly states it is a physical implantable cage constructed from Titanium alloy, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Stryker Spine Tritanium® PL Cage is a physical implant designed to be surgically placed in the spine to aid in fusion. It is a structural device, not a test performed on a biological sample.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing.
Therefore, the Tritanium® PL Cage falls under the category of a surgical implant or medical device, not an in vitro diagnostic.
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
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spinal, lumbosacral spine, 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 scope of this Traditional 510(k) submission includes device modifications for the Tritanium® PL Cages which were previously cleared under K152304.
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/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a stylized image of three faces in profile. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the image.
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
1
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
2
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)
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) |
|---|---|
| ------------------------------------------------------------ | ----------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
| 510(k) Summary as required by 21 CFR §807.92(c).
| Tritanium® PL Cage | |
|---|---|
| Submitted by | Stryker Spine |
| 2 Pearl Court | |
| Allendale, New Jersey 07401 | |
| Contact Person | Deirdre Jayko |
| Regulatory Affairs Associate | |
| Phone: 201-749-8339 | |
| Email: 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 Name | |
| and 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 substantial |
| equivalence is claimed: | |
| • Primary predicate | |
| Stryker Spine Tritanium® PL Cage (K152304) | |
| 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. | |
| Intended Use and | |
| 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 | |
| 510(k) Summary as required by 21 CFR §807.92(c). | |
| Tritanium® PL Cage | |
| 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 identical materials, |
| design features, and fundamental scientific technologies as the | |
| predicate Tritanium® PL Cage. | |
| Summary of | |
| Non-Clinical Testing | The scope of this Traditional 510(k) submission includes device |
| modifications for the Tritanium® PL Cages which were | |
| previously cleared under K152304. | |
| Bacterial endotoxin testing (BET) as specified in ANSI/AAMI | |
| ST72:2011 is used for pyrogenicity testing to achieve the | |
| Endotoxin limit of |