(266 days)
Not Found
No
The 510(k) summary describes a passive, physical implant (intervertebral body fusion device) and its mechanical properties. There is no mention of software, algorithms, data processing, or any features that would suggest the use of AI or ML. The performance studies focus on mechanical testing and bacterial endotoxin testing, not algorithmic performance.
No.
The device is an intervertebral body fusion device used in spinal fusion procedures to provide structural support and facilitate bone growth; it does not directly treat or cure degenerative disc disease.
No
Explanation: This device is an intervertebral body fusion device designed for spinal fusion procedures, not for diagnosing medical conditions.
No
The device description clearly states it is an implant made of titanium alloy, which is a hardware component. The intended use also describes a physical implant for spinal fusion.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a lumbar intervertebral body fusion device for spinal fusion procedures. This is a surgical implant used in vivo (within the body) to facilitate bone fusion.
- Device Description: The description details a physical implant made of titanium alloy, designed to be placed between vertebrae.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
When used as a lumbar intervertebral body fusion device, the Zyston Strut Open Titanium Interbody Spacer System is intended for spinal fusion procedures to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Zyston Strut Open Titanium Interbody Spacer System is to be implanted via a posterior approach and is to be combined with supplemental fixation. The titanium fusion devices are not indicated for vertebral body replacement.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Zyston Strut Open Titanium Spacer System implants are intervertebral body fusion devices consisting of a rectangular or semi-rectangular shape and various heights and footprints. The devices have an open central area to accommodate autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The implants are available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The implants are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F2924. The Zyston Strut Open Titanium Spacer System implants incorporate lordotic angles of 0 and 10 degrees. The implants are available in 7 to 16mm heights, 10 and 11mm widths, and 21 to 38mm lengths depending on the implant configuration. The Zyston Strut Open Titanium Spacer System implants are intended to be provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar, L2-S1
Indicated Patient Age Range
skeletally mature patients
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)
Mechanical testing was conducted in accordance with FDA's Guidance for Industry and FDA Staff -Spinal System 510(k)s dated May 3, 2004 and Class II Special Controls Guidance Document: Intervertebral Body Fusion Device dated June 12, 2007. Performance testing was performed to demonstrate substantial equivalence to the predicate device(s). Performance tests per ASTM F2077 (static and dynamic axial compression, static and dynamic shear compression, and static torsion) and ASTM F2267 (subsidence). Bacterial endotoxin testing (LAL) 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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 12, 2018
Zimmer Biomet Spine Inc. Ms. Megan Fessenden Regulatory Affairs, Senior Specialist 10225 Westmoor Drive Westminster, Colorado 80021
Re: K171495
Trade/Device Name: Zyston Strut Open Titanium Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: January 9, 2018 Received: January 11, 2018
Dear Ms. Fessenden:
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);
1
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 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
2
Indications for Use
510(k) Number (if known)
K171495
Device Name Zyston Strut Open Titanium Spacer System
Indications for Use (Describe)
When used as a lumbar intervertebral body fusion device, the Zyston Strut Open Titanium Interbody Spacer System is intended for spinal fusion procedures to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Zyston Strut Open Titanium Interbody Spacer System is to be implanted via a posterior approach and is to be combined with supplemental fixation. The titanium fusion devices are not indicated for vertebral body replacement.
| Type of Use (Select one or both, as applicable) |
|---|
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/2 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is in a dark gray color, contrasting with the light background.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
| Preparation Date | January 31, 2018 |
|---|---|
| Applicant/Sponsor | Zimmer Biomet Spine Inc |
| 10225 Westmoor Dr. | |
| Westminster, CO 80021 | |
| Contact Person | Megan Fessenden |
| Regulatory Affairs, Senior Specialist | |
| Phone: 303-465-8994 | |
| Fax: 303-501-8444 | |
| Trade Name | Zyston Strut Open Titanium Spacer System |
| Common Name | Intervertebral Body Fusion Device, Lumbar |
| Device Class | Class II |
| Classification Name | Intervertebral fusion device with bone graft, lumbar |
| Product Code | MAX |
| Device Panel - Regulation No. | Orthopedic - 21 CFR 888.3080 |
| Primary Predicate | K143258 - 4Web Spine Truss System (STS) |
| Additional Predicates | K162262 - Stryker Tritnaium PL Cage, K153695 - Biomet |
| Spine Fusion System |
Device Description & Technological Characteristics:
The Zyston Strut Open Titanium Spacer System implants are intervertebral body fusion devices consisting of a rectangular or semi-rectangular shape and various heights and footprints. The devices have an open central area to accommodate autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The implants are available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The implants are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F2924. The Zyston Strut Open Titanium Spacer System implants incorporate lordotic angles of 0 and 10 degrees. The implants are available in 7 to 16mm heights, 10 and 11mm widths, and 21 to 38mm lengths depending on the implant configuration. The Zyston Strut Open Titanium Spacer System implants are intended to be provided sterile.
Intended Use / Indications for Use:
When used as a lumbar intervertebral body fusion device, the Zyston Strut Open Titanium
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Image /page/4/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo consists of a stylized blue "Z" symbol followed by the text "ZIMMER BIOMET" in a simple, sans-serif font. Above the logo on the right side of the image is the text "R1/14".
Interbody Spacer System is intended for spinal fusion procedures to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis at the involved level(s). The Zyston Strut Open Titanium Interbody Spacer System is to be implanted via a posterior approach and is to be combined with supplemental fixation. The titanium fusion devices are not indicated for vertebral body replacement.
Summary of Technologies:
The technological characteristics of the subject Zyston Strut Open Titanium Spacer System components remain the same as, or similar to, the predicate devices in regards to intended use, indications for use, design, materials, fundamental technology, and operational principles.
Performance Data:
Mechanical testing was conducted in accordance with FDA's Guidance for Industry and FDA Staff -Spinal System 510(k)s dated May 3, 2004 and Class II Special Controls Guidance Document: Intervertebral Body Fusion Device dated June 12, 2007. Performance testing was performed to demonstrate substantial equivalence to the predicate device(s). Performance tests per ASTM F2077 (static and dynamic axial compression, static and dynamic shear compression, and static torsion) and ASTM F2267 (subsidence). Bacterial endotoxin testing (LAL) as specified in ANSI/ AAMI ST72:2011 is used for pyrogenicity testing to achieve the Endotoxin limit of