Z-LINKPC System

K162575 · Zavation, LLC · NKG · Mar 3, 2017 · Orthopedic

Device Facts

• Record ID: K162575
• Device Name: Z-LINKPC System
• Applicant: Zavation, LLC
• Product Code: NKG · Orthopedic
• Decision Date: Mar 3, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3075
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Z-LINK.pc 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 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. In order to achieve additional levels of fixation, the Z-LINKPC System may be connected to the Zavation System using rod connectors and tapered rods.

Device Story

Z-LINKpc System is a temporary, non-sterile, single-use spinal fixation system; components include polyaxial screws, hooks, rods, cross-connectors, rod connectors, offsets, and cap screws. Used by surgeons in clinical settings to immobilize cervical (C1-C7) and thoracic (T1-T3) spinal segments. System provides mechanical stabilization as an adjunct to fusion or for palliative support in advanced tumor cases. Components are available in various sizes to accommodate patient anatomy; can connect to Zavation Spinal System via rod connectors/tapered rods for extended fixation. Surgeon selects and implants components to restore spinal integrity; clinical benefit includes stabilization of unstable segments and pain relief associated with degenerative or traumatic conditions.

Clinical Evidence

Bench testing only. Static axial compression, bending, and torsion, and dynamic axial compression bending tests performed per ASTM F1717. Axial and torsional grip tests performed per ASTM F1798. Results demonstrate performance equivalent or superior to predicate devices.

Technological Characteristics

Titanium alloy (Ti-6AL-4V ELI per ASTM F136). Components: polyaxial screws, hooks, rods, cross-connectors, rod connectors, offsets, cap screws. Mechanical fixation via screw/rod construct. Non-sterile, single-use. No software or electronic components.

Indications for Use

Indicated for patients with acute/chronic cervical (C1-C7) or thoracic (T1-T3) spine instability requiring immobilization as an adjunct to fusion, including traumatic fractures/dislocations, deformity, failed fusions, tumors, or degenerative disease (radiculopathy, myelopathy, discogenic pain, facet instability). Also indicated for spinal column integrity restoration in advanced-stage cervical tumor patients with limited life expectancy where fusion is not achievable.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Synthes, Synapse System (K142838)
• Biomet, Altius System (K122378)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Zavation, LLC Mr. Frankie Cummins Engineer 220 Lakeland Parkway Flowood, Mississippi 39232

Re: K162575

Trade/Device Name: Z-LINKpc System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: February 6, 2017 Received: February 7, 2017

Dear Mr. Cummins:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.

March 3, 2017

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Mark N. Melkerson -S

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) K162575

Device Name Z-LINKPC System

#### Indications for Use (Describe)

The Z-LINK.pc 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 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.

In order to achieve additional levels of fixation, the Z-LINKPC System may be connected to the Zavation System using rod connectors and tapered rods.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span style="margin-right:5px;">☑</span>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span style="margin-right:5px;">☐</span>Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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# 510K Summary

| Date: | March 2, 2017 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Zavation, LLC<br>220 Lakeland Parkway<br>Flowood, MS 39232<br>Phone: [phone]<br>Fax: [phone] |
| Contact person: | Frankie Cummins |
| Trade name: | Z-LINK _PC System |
| Classification: | Cervical Pedicle Spinal Fixation Orthosis<br>Product Code: NKG<br>Regulatory Class: Unclassified, Pre-Amendment |
| | Per 21 CFR as follows:<br>888.3050 Spinal Interlaminal Fixation Orthosis<br>Product Code: KWP<br>Regulatory Class: II, Panel Code: 87 |
| Predicates: | Primary: K142838 Synthes, Synapse System<br>Additional: K122378 Biomet, Altius System |

#### Device Description:

The Z-LINKمc System is a temporary, titanium alloy (Ti-6AL-4V ELI per ASTM F136), 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 and cap screws. The components are available in a variety of lengths and sizes in order to accommodate patient anatomy.

#### Intended Use:

The Z-LINKsc 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

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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.

In order to achieve additional levels of fixation, the Z-LINKPC System may be connected to the Zavation Spinal System using rod connectors and tapered rods.

## Technological Characteristics:

The Z-LINKec system possesses the same technological characteristics, design and principles of operation as the predicates. These include: basic design, material, intended use and indications.

#### Performance Data:

Static axial compression bending and torsion, and dynamic axial compression bending test were performed according to ASTM F1717 on a worst-case construct. Axial and torsional grip test were performed according to ASTM F1798 on the connectors. The mechanical test results demonstrated the Z-LINKoc system performs as well as or better than the predicate devices.

## Conclusion:

The Z-LINKec system is substantially equivalent to the predicate device referenced above.