(44 days)
Not Found
No
The summary describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended to "provide immobilization and stabilization of spinal segments as an adjunct to fusion" and "restore the integrity of the spinal column," which are therapeutic actions.
No
The Z-LINKpc System is described as implants intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion, not to diagnose medical conditions.
No
The device description explicitly states it is comprised of multiple component implantable hardware made of titanium and cobalt chrome alloys.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests 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 provided text clearly describes the Z-LINKpc System as a system of implants (screws, hooks, rods, etc.) intended for surgical implantation to provide immobilization and stabilization of spinal segments. This is a physical implant used within the body, not a device used to test samples outside the body.
The information provided describes a surgical implant system, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The Z-LINKpc System implants are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations: instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. These implants are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
To achieve additional levels of fixation, the Z-LINKsc System may be connected to the Zavation Spinal System using rod connectors and tapered rods.
When used with the occipital plate, the Z-LINKpc System is also intended to provide immobilization and stabilization for the occipito-cervico-thoracic juction (occiput-T3) in treatment of the instabilities mentioned above, including occipitocervical dislocation.
Product codes (comma separated list FDA assigned to the subject device)
NKG, KWP
Device Description
The Z-LINKsc System is a temporary, titanium alloy (Ti-6AL-4V ELI per ASTM F136) and cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537), multiple component system comprised of a variety of non-sterile, single use implantable components. The system consist of polyaxial screws, hooks, rods, cross-connectors, rod connectors, offsets, occipital plates, bone screws, and cap screws. The components are available in a variety of lengths and sizes in order to accommodate patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C1-C7), thoracic spine (T1-T3), occipito-cervico-thoracic junction (occiput-T3)
Indicated Patient Age Range
Not Found
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)
Static compression bending and torsion, dynamic compression bending, and dynamic torsion tests were performed according to ASTM F2706 on a worst-case construct. The mechanical test results demonstrated the Z-LINKoc system performs as well as or better than the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.
0
August 11, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Zavation Medical Products LLC Colby Williams Engineer 220 Lakeland Parkway Flowood, Mississippi 39232
Re: K211993
Trade/Device Name: Z-LINKpc System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: NKG, KWP Dated: June 25, 2021 Received: June 28, 2021
Dear Colby Williams:
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 (QS) 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,
Colin O'Neill, M.B.E. Assistant Director 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) K211993
Device Name
Z-LINKpc System
Indications for Use (Describe)
The Z-LINKpc System implants are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations: instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. These implants are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
To achieve additional levels of fixation, the Z-LINKsc System may be connected to the Zavation Spinal System using rod connectors and tapered rods.
When used with the occipital plate, the Z-LINKpc System is also intended to provide immobilization and stabilization for the occipito-cervico-thoracic juction (occiput-T3) in treatment of the instabilities mentioned above, including occipitocervical dislocation.
| 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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3
510K Summary
| Date: | June 25, 2021 |
|---|---|
| Submitter: | Zavation Medical Products LLC |
| 220 Lakeland Pkwy | |
| Flowood, MS 39232 | |
| Phone: 601-919-1119 | |
| Fax: 800-447-1302 | |
| Contact Person: | Colby Williams |
| Type of 510(k) submission: | Traditional |
| Trade name: | Z-LINKPC System |
| Classification regulation: | 21 CFR 888.3075 Posterior Cervical Screw System |
| 21 CFR 888.3050 Spinal Interlaminal Fixation Orthosis | |
| Device classification: | Class II |
| Classification Panel: | Orthopedic Devices |
| Product code: | NKG, KWP |
| Basis for submission: | Addition of occipital plate. |
Device Description:
The Z-LINKsc System is a temporary, titanium alloy (Ti-6AL-4V ELI per ASTM F136) and cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537), multiple component system comprised of a variety of non-sterile, single use implantable components. The system consist of polyaxial screws, hooks, rods, cross-connectors, rod connectors, offsets, occipital plates, bone screws, and cap screws. The components are available in a variety of lengths and sizes in order to accommodate patient anatomy.
Indications for Use:
The Z-LINKoc System implants are intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. These implants are also intended to restore the integrity of the spinal column even in the absence of fusion for a
4
limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
To achieve additional levels of fixation, the Z-LINKrc System may be connected to the Zavation Spinal System using rod connectors and tapered rods.
When used with the Occipital Plate, the Z-LINKsc System is also intended to provide immobilization and stabilization for the occipito-cervico-thoracic junction (occiput-T3) in treatment of the instabilities mentioned above, including occipitocervical dislocation.
Materials:
The Z-LINKec System components are manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136, and cobalt chromium alloy (Co-28Cr-6Mo) as described by ASTM F1537.
Primary Predicate Device:
K180198 Nuvasive Viewpoint
Additional Predicate Device:
K180025 Orthofix Centurion
Technological Characteristics:
The Z-LINKoc system possesses the same technological characteristics as the predicate devices. These include basic design (rod based fixation system having occipital bone screws and various accessories), material (titanium alloy/cobalt chrome alloy), mechanical safety and performance, and intended use.
Performance Data:
Static compression bending and torsion, dynamic compression bending, and dynamic torsion tests were performed according to ASTM F2706 on a worst-case construct. The mechanical test results demonstrated the Z-LINKoc system performs as well as or better than the predicate devices.
Conclusion:
The Z-LINKsc System is similar to the predicate systems with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject to the predicate devices.