inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System

K143626 · Zimmer Spine, Inc. · KWQ · Mar 20, 2015 · Orthopedic

Device Facts

• Record ID: K143626
• Device Name: inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System
• Applicant: Zimmer Spine, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Mar 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The inViZia® Anterior Cervical Plate System is designed for anterior interbody screw fixation of the cervical spine at levels C2-T1. The inViZia® Anterior Cervical Plate System is in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions. WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Story

System comprises titanium alloy (Ti-6Al-4V ELI) plates and bone screws; used for temporary spinal stabilization during fusion. Implants secured via locking caps or Secure Ring® mechanism. Used in surgical settings by orthopedic/neurosurgeons. Device provides mechanical support to spine; removed after solid fusion. Submission updates labeling for MRI conditional safety. No changes to device design, materials, or surgical technique.

Clinical Evidence

No clinical data. Bench testing only: MRI safety assessment performed per ASTM F2052, F2119, F2182, and F2213 to support MRI conditional labeling.

Technological Characteristics

Implants: Ti-6Al-4V ELI titanium alloy. Instrumentation: stainless steel, plastic, aluminum, silicone. Mechanical fixation via plates, screws, locking caps, and Secure Ring®. Non-sterile, single-use implants; reusable instrumentation. MRI safety tested per ASTM F2052, F2119, F2182, F2213.

Indications for Use

Indicated for temporary stabilization of cervical (C2-T1/C2-C7) or thoracolumbar (T1-L5) spine during fusion. Patient population includes those with degenerative disc disease, trauma (fractures), tumors, deformity (scoliosis, kyphosis, lordosis), spondylolisthesis, spinal stenosis, pseudoarthrosis, or failed previous fusions. Contraindicated for posterior element (pedicle) attachment.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• V2F Anterior Fixation System (K122733)
• inViZia Anterior Cervical Plate System (K111796)
• SC-AcuFix Ant-Cer Dynamic Cervical Plating System (K052072)
• SC-AcuFix Slimline Anterior Cervical Plate System (K990005)
• SC-AcuFix Thinline Anterior Cervical Plate System (K013979)
• Trinica Anterior Lumbar Plate System (K140611)
• Trinica and Trinica Select Anterior Cervical Plate System (K132012)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized depiction of human profiles facing right, with three distinct faces layered on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

March 20, 2015

Zimmer Spine, Incorporated % Ms. Donna M. Semlak Senior Regulatory Affairs Specialist 7375 Bush Lake Road Minneapolis, Minnesota 55439

#### Re: K143626

Trade/Device Name: inVizia Anterior Certical Plate System, SC-AcuFix® Ant-Cer Dynamic Cervical Plating System, SC-AcuFix® Slimline® Anterior Cervical Plate System, SC-AcuFix® Thinline® Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica Anterior Cervical Plate System and Trinica® Select Anterior Cervical Plate System, V2FTM Anterior Fixation System

Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: December 19, 2014 Received: December 22, 2014

## Dear Ms. Semlak:

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.

{1}------------------------------------------------

Page 2 - Ms. Donna M. Semlak

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

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,

# Lori A. Wiggins -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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K143626

Device Name inViZia® Anterior Cervical Plate System

Indications for Use (Describe)

The in ViZi® Anterior Cervical Plate System is designed for anterior interbody screw fixation of the cervical spine at levels C2-T1.

The inViZia® Anterior Cervical Plate System is in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

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)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

{3}------------------------------------------------

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{4}------------------------------------------------

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K143626

Device Name

SC-AcuFix® Ant-Cer Dynamic Cervical Plating System

Indications for Use (Describe)

The SC-AcuFix® Ant-Cert Dynamic Anterior Cervical Plate System is in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion inpatients with instability caused by the following: degenerative disc disease (as defined by neck pain of discogenic origin with denegation of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, deformity (i.e. scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.

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)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

{5}------------------------------------------------

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{6}------------------------------------------------

## Indications for Use

510(k) Number (if known) K143626

#### Device Name

SC-AcuFix® Slimline® Anterior Cervical Plate System

Indications for Use (Describe)

The Spinal Concepts Inc. (SCI) Anterior Cervical Plate System is in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion inpatients with instability caused by the following: degenerative disc disease (as defined by neck pain of discogenic origin with denegation of the disc confirmed by patient history and radies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, kyphosis, lordosis, lordosis), pseudarthrosis, and failed previous fusions.

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)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

{7}------------------------------------------------

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{8}------------------------------------------------

## Indications for Use

510(k) Number (if known) K143626

#### Device Name

SC-AcuFix® Thinline® Anterior Cervical Plate System

Indications for Use (Describe)

The SC-AcuFix® Thinline Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion inpatients with instability caused by the following: degenerative disc disease (as defined by neck pain of discogenic origin with denegation of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e. scoliosis, lordosis), pseudarthrosis, and failed previous fusions.

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)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

{9}------------------------------------------------

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{10}------------------------------------------------

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K143626

Device Name Trinica® Anterior Lumbar Plate System

#### Indications for Use (Describe)

The Trinica® Anterior Lumbar Plate System is interal or anterolateral surgical approach above the bifuration of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. This system is indicated in the treatment of lumbar or lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, scoliosis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous fusion. .

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)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

{11}------------------------------------------------

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{12}------------------------------------------------

## Indications for Use

#### 510(k) Number (if known) K143626

#### Device Name

Trinica® Anterior Cervical Plate System and Trinica® Select Anterior Cervical Plate System

#### Indications for Use (Describe)

The Trinica® and Trinica® Select Anterior Cervical Plate System is interior interbody screw fixation of the cervical spine at level C2-T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degeneratived by neck pain of discogenc origin confirmed by patient history and radiographic studies), trauma (including fractures), turnors, deformity (defined as kyphosis, or scoliosis), pseudoarthrosis and/or failed previous fusions.

WARNING: These devices are not approved for screw attachments (pedicles) of the cervical, thoracic, or lumbar spine.

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)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

{13}------------------------------------------------

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{14}------------------------------------------------

## Indications for Use

510(k) Number (if known) K143626

Device Name V2FTM Anterior Fixation System

Indications for Use (Describe)

.

The V2F Anterior Fixation System is indicated for use via the lateral or anterolateral surgical in the treatment of thoracc and thoracolumbar (TI-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

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)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

{15}------------------------------------------------

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{16}------------------------------------------------

Image /page/16/Picture/1 description: The image shows the logo for Zimmer Spine. The logo features a large, light blue circle with a stylized "Z" inside. Below the circle, the word "zimmer" is written in a lowercase, sans-serif font, also in light blue. Underneath "zimmer", the word "spine" is written in a smaller font, with a line above it.

## 510(k) SUMMARY

Anterior Cervical and Lumbar

| Date of Summary Preparation: | March 13, 2015 |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Zimmer Spine, Inc.<br>7375 Bush Lake Road<br>Minneapolis, MN 55439<br>USA |
| Establishment Registration<br>Number: | 2184052 (Minneapolis) |
| Company Contact (Primary): | Donna M. Semlak<br>Senior Regulatory Affairs Specialist<br>Email: [e-mail]<br>Office: 952.857.5643<br>Email Fax: [phone] |
| Common Name(s): | Appliance, Fixation, Spinal Intervertebral Body |
| Device/ Trade Names(s): | inViZia® Anterior Cervical Plate System<br>SC-AcuFix® Ant-Cer Dynamic Cervical Plating System<br>SC-AcuFix® Slimline® Anterior Cervical Plate System<br>SC-AcuFix® Thinline® Anterior Cervical Plate System<br>Trinica® Anterior Lumbar Plate System<br>Trinica® and Trinica® Select Anterior Cervical Plate System<br>V2FTM Anterior Fixation System |
| Device Classification: | Class II |
| Regulation Number and<br>Product Code(s): | 21 CFR § 888.3060 / KWQ<br>Spinal intervertebral body fixation orthosis |

{17}------------------------------------------------

## Predicate Devices:

The primary predicate device for this submission is the currently marketed Zimmer Spine Anterior Cervical and Lumbar Plate System listed below. The purpose of this submission is to update product specific package inserts (IFU) with MRI Conditional language only.

| Product Name | FDA 501(k) or<br>PMA Numbers | Classification | Primary Code |
|-------------------------------------------|------------------------------|----------------|--------------------------|
| V2F <i>TM</i> Anterior<br>Fixation System | K122733 | Class II | KWQ<br>21 CFR § 888.3060 |

## Additional Predicate Devices:

| Product Name | FDA 501(k) or<br>PMA Numbers | Classification | Primary Code | Product Name | Indications For Use |
|----------------------------------------------------------------------------------------------------|------------------------------|----------------|--------------------------|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| inViZia® Anterior<br>Cervical Plate System | K111796 | Class II | KWQ<br>21 CFR § 888.3060 | <i>in ViZia</i> ®<br>Anterior<br>Cervical Plate<br>System | The <i>inViZia</i> ® Anterior Cervical Plate System is designed for anterior interbody<br>screw fixation of the cervical spine at levels C2-T1.<br><br>The <i>in ViZia</i> ® Anterior Cervical Plate System is indicated for use in the temporary<br>stabilization of the anterior spine during the development of cervical spinal fusions<br>in patients with degenerative disc disease (as defined by neck pain of discogenic<br>origin with degeneration of the disc confirmed by patient history and radiographic<br>studies), trauma (including fractures), tumors, deformity (defined as kyphosis,<br>lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions.<br><br>WARNING: This device is not approved for screw attachment to the posterior<br>elements (pedicles) of the cervical, thoracic, or lumbar spine. |
| SC-AcuFix® Ant-Cer<br>Dynamic Cervical<br>Plating System | K052072 | Class II | KWQ<br>21 CFR § 888.3060 | SC-AcuFix®<br>Ant-Cer<br>Dynamic<br>Cervical<br>Plating<br>System | The SC-AcuFix® Ant-Cert Dynamic Anterior Cervical Plate System is indicated for<br>use in the temporary stabilization of the cervical spine (C2-C7) during the<br>development of solid spinal fusion inpatients with instability caused by the<br>following: degenerative disc disease (as defined by neck pain of discogenic origin<br>with denegation of the disc confirmed by patient history and radiographic studies),<br>trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity<br>(i.e. scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions. |
| SC-AcuFix® Slimline®<br>Anterior Cervical Plate<br>System | K990005 | Class II | KWQ<br>21 CFR § 888.3060 | SC-AcuFix®<br>Slimline®<br>Anterior<br>Cervical Plate<br>System | The Spinal Concepts Inc. (SCI) Anterior Cervical Plate System is indicated for<br>use in the temporary stabilization of the cervical spine (C2-C7) during the<br>development of solid spinal fusion inpatients with instability caused by the<br>following: degenerative disc disease (as defined by neck pain of discogenic origin<br>with denegation of the disc confirmed by patient history and radiographic studies),<br>trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity<br>(i.e. scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions. |
| SC-AcuFix® Thinline®<br>Anterior Cervical Plate<br>System | K013979 | Class II | KWQ<br>21 CFR § 888.3060 | SC-AcuFix®<br>Thinline®<br>Anterior<br>Cervical Plate<br>System | The SC-AcuFix® Thinline Anterior Cervical Plate System is indicated for use in the<br>temporary stabilization of the cervical spine (C2-C7) during the development of<br>solid spinal fusion inpatients with instability caused by the following: degenerative<br>disc disease (as defined by neck pain of discogenic origin with denegation of the<br>disc confirmed by patient history and radiographic studies), trauma (including<br>fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e. scoliosis,<br>kyphosis, lordosis), pseudarthrosis, and failed previous fusions. |
| Trinica® Anterior<br>Lumbar Plate System | K140611 | Class II | KWQ<br>21 CFR § 888.3060 | Trinica®<br>Anterior<br>Lumbar Plate | The Trinica® Anterior Lumbar Plate System is indicated for use via the lateral or<br>anterolateral surgical approach above the bifurcation of the great vessels or via<br>the anterior surgical approach, below the bifurcation of the great vessels. This<br>system is indicated in the treatment of lumbar or lumbosacral (L1-S1) spine |
| Trinica® Anterior<br>Cervical Plate System<br>Trinica® Select<br>Anterior Cervical Plate<br>System | K132012 | Class II | KWQ<br>21 CFR § 888.3060 | | |

There are no reference devices for this submission.

## General Device Description:

The Zimmer Spine Anterior Cervical and Lumbar Plate Systems are intended to provide stabilization of the spine during the development of a solid spinal fusion in patients per the system(s) indications at various spinal levels. The Zimmer Spine Anterior Cervical and Lumbar Plate Systems consist of plates, bone screws and instruments necessary to implant the specific system. Bone screws are secured to the plate through locking caps and/or a Secure Ring® mechanism. The plates are available in various sizes and lengths and the bone screws are available in various diameters and lengths.

The subject devices are temporary implants to be implanted per the indications for use and/or the instructions of the surgical technique guide(s). These subject implants are intended to be removed after solid fusion has occurred.

{18}------------------------------------------------

The Zimmer Spine Anterior Cervical and Lumbar Plate implants (plates and bone screws) are manufactured from medical grade Ti-6Al-4V ELI titanium alloy. The system's instrumentation is manufactured from one (or more) of the following medical/surgical grade materials: stainless steel, plastic, aluminum, and silicone.

The subject implants are provided non-sterile and must be sterilized by the enduser/healthcare facility prior to use. The subject implants are designed for single-use only. The system's instrumentation is provided to the end-user/healthcare facility clean but not sterile. The end-user/healthcare facility ensures through cleaning and sterilization of instrumentation before use and the instrumentation may be reused. Selective plate systems contain drill bits and/or fixation pins that are provided to the end-user sterile and designed for single-use.

## Indications for Use:

{19}------------------------------------------------

| Product Name | Indications For Use |
|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System | instability as a result of fracture (including dislocation and subluxation), tumor,<br>degenerative disc disease (defined as back pain of discogenic origin with<br>degeneration of the disc confirmed by history and radiographic studies),<br>pseudoarthrosis, spondylolisthesis, scoliosis, lordotic deformities of the spine,<br>spinal stenosis, or a failed previous fusion. |
| Trinica®<br>Anterior<br>Cervical Plate<br>System<br>Trinica® Select<br>Anterior<br>Cervical Plate<br>System | The Trinica® and Trinica® Select Anterior Cervical Plate System is intended for<br>anterior interbody screw fixation of the cervical spine at level C2-T1. The system<br>is indicated for use in the temporary stabilization of the anterior spine during the<br>development of cervical spinal fusions in patients with degenerative disc disease<br>(as defined by neck pain of discogenic origin confirmed by patient history and<br>radiographic studies), trauma (including fractures), tumors, deformity (defined as<br>kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions.<br>WARNING: These devices are not approved for screw attachment to the posterior<br>elements (pedicles) of the cervical, thoracic, or lumbar spine. |
| V2FTM<br>Anterior<br>Fixation<br>System | The V2FTM Anterior Fixation System is indicated for use via the lateral or<br>anterolateral surgical approach in the treatment of thoracic and thoracolumbar<br>(T1-L5) spine instability as a result of fracture (including dislocation and<br>subluxation), tumor, degenerative disc disease (defined as back pain of<br>discogenic origin with degeneration of the disc confirmed by patient history and<br>radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed<br>previous spine surgery. |

## Summary of Technological Characteristics:

The technological characteristics remain the same between the subject Zimmer Spine Anterior Cervical and Lumbar Plate Systems as the predicate devices listed above. There are no changes to the implants (plate and bone screws) and instrumentation within this submission. This submission is only proposing labeling updates regarding interactions with magnetic fields during Magnetic Resonance Imaging (MRI) with respect to patient safety.

All the technology characteristics remain the same: same system's intended use, same mechanical and functional scientific technology; same materials and the same substantially equivalent performance characteristics.

## Summary of Performance Testing:

Magnetic Resonance Imaging (MRI) testing of Plate implants contained in the Zimmer Spine Anterior Cervical and Lumbar Plate Systems were assessed and tested appropriately to design controls; i.e. ASTM Standards.

- ASTM F2052: 2006 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- ASTM F2119: 2007 Standard Test Method for Evaluation of MR Image Artifacts from ● Passive Implants
- . ASTM F2182: 11a* Standard Test Method of Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging

{20}------------------------------------------------

- . ASTM F2213: 2006 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
No further device performance (bench) testing was required for this submission. The performance (bench) testing remains the same for the currently marketed Zimmer Spine Anterior Cervical and Lumbar Plate Systems listed as above predicates.

No further sterilization, biocompatibility and cvtotoxicity evaluation and/or testing were required for this submission. The sterilization, biocompatibility and cvtotoxicity testing remains the same for the currently marketed Zimmer Spine Anterior Cervical and Lumbar Plate Systems listed as above predicates.

## Substantial Equivalence

Zimmer Spine considers the subject Zimmer Spine Anterior Cervical and Lumbar Plate Systems to be substantially equivalent to the currently marketed (predicate) Zimmer Spine Anterior Cervical and Lumbar Plate Systems listed as above because:

- No changes to the intended use, .
- No changes to mechanical and functional performance,
- . No changes to the functional scientific technology,
- No changes to the implants,
- No changes to the instrumentation, .
- No changes to the technological characteristics mentioned above ●
- No changes to the surgical technique steps