(111 days)
Not Found
No
The summary describes a mechanical implant 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 indicated for degenerative disc disease to provide fusion and alleviate radicular symptoms, which directly targets and treats a medical condition.
No
The Z-Link Cervical is an interbody fusion device designed for treatment, not diagnosis. Its purpose is to facilitate fusion, not to identify or characterize a disease.
No
The device description explicitly states it includes physical components like a PEEK spacer, titanium interbody plate, and screws, which are hardware.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The Z-Link Cervical is a physical implantable device (a fusion device) used in surgery to stabilize the cervical spine. It is not a test performed on a sample.
- Intended Use: The intended use is for surgical implantation to treat degenerative disc disease, not for analyzing biological samples.
- Performance Studies: The performance studies described are mechanical tests on the device itself, not clinical studies evaluating the accuracy of a diagnostic test.
The Z-Link Cervical is a medical device, specifically an implantable surgical device.
N/A
Intended Use / Indications for Use
The Z-Link Cervical is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Z-Link Cervical should be packed with autogenous bone graft and implanted with an anterior approach.
Product codes
OVE
Device Description
The Zavation Z-Link Cervical includes a PEEK spacer, titanium interbody plate and screws. The spacer component is assembled to an interbody plate and implanted anteriorly. The endplate contacting surfaces of the spacer component include serrations, and the plate component includes two holes for inserting one bone screw in each vertebral body. The plate component also includes a screw lock at each hole. The bone screws are available in a variety of diameters and lengths. The interbody plate components are available in a variety of heights. The spacer components are available in a variety of depths, widths, and heights.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, C2-T1
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 test results demonstrated that the Zavation Z-Link Cervical is substantially equivalent to the predicate devices. Testing was performed in accordance with:
- ASTM F2077, Test Methods for Intervertebral Body Fusion Devices
- Static Axial Compression
- Dynamic Axial Compression
- Static Torsion
- Dynamic Torsion
- ASTM F2267, Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression
- ASTM Draft F04.25.02.02, Static Pushout Test Method for Intervertebral Body Fusion Devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K091088, K120576, K121852, K122630, K131449
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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2014
Zavation, LLC Mr. John Walker Engineering Manager 400 Liberty Park Drive Flowood, Mississippi 39232
K141005 Re: Trade/Device Name: Zavation Z-Link Cervical Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: July 22, 2014 Received: July 24, 2014
Dear Mr. Walker:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
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,
Ronald & Nean -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) K141005
Device Name Zavation Z-Link Cervical
Indications for Use (Describe)
The Z-Link Cervical is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Z-Link Cervical should be packed with autogenous bone graft and implanted with an anterior approach.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Anton E. Dmitriev, PhD
Division of Orthopedic Devices
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510K Summary
| Date: | August 4, 2014 |
|---|---|
| Submitter: | Zavation LLC |
| 400 Liberty Park Drive | |
| Flowood, MS 39232 | |
| Phone: 601-919-1119 | |
| Fax: 800-447-1302 | |
| Contact person: | John Walker |
| Type of 510(k) submission: | Traditional |
| Trade name: | Zavation Z-Link Cervical |
| Common name: | Intervertebral Body Fusion Device |
| Classification regulation: | 21 CFR 888.3080 Intervertebral body fusion device |
| Device classification: | Class II |
| Classification Panel: | Orthopedic |
| Product code: | OVE |
| Basis for submission: | New device |
Device Description:
The Zavation Z-Link Cervical includes a PEEK spacer, titanium interbody plate and screws. The spacer component is assembled to an interbody plate and implanted anteriorly. The endplate contacting surfaces of the spacer component include serrations, and the plate component includes two holes for inserting one bone screw in each vertebral body. The plate component also includes a screw lock at each hole. The bone screws are available in a variety of diameters and lengths. The interbody plate components are available in a variety of heights. The spacer components are available in a variety of depths, widths, and heights.
4
Intended Use:
The Z-Link Cervical is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Z-Link Cervical should be packed with autogenous bone graft and implanted with an anterior approach.
Materials:
The spacer component is manufactured from medical grade PEEK Zeniva ZA-500 (ASTM F2026) with a Tantalum alloy position marker (ASTM F560). The plate and screws are titanium alloy (ASTM F136).
Predicate Devices:
LDR Spine Cervical Interbody Fusion System (K091088) Zavation IBF System (K120576) Synthes Zero-P VA (K121852) SpineSmith IN:C2 Spinal Fixation System (K122630) Globus Coalition Spacer (K131449)
Performance Data:
Mechanical test results demonstrated that the Zavation Z-Link Cervical is substantially equivalent to the predicate devices. Testing was performed in accordance with:
- · ASTM F2077, Test Methods for Intervertebral Body Fusion Devices
- o Static Axial Compression
- Dynamic Axial Compression o
- Static Torsion o
- o Dynamic Torsion
- . ASTM F2267, Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression
- . ASTM Draft F04.25.02.02, Static Pushout Test Method for Intervertebral Body Fusion Devices.