TRINICA ANTERIOR LUMBAR PLATE SYSTEM

K140611 · Zimmer Spine, Inc. · KWQ · May 21, 2014 · Orthopedic

Device Facts

• Record ID: K140611
• Device Name: TRINICA ANTERIOR LUMBAR PLATE SYSTEM
• Applicant: Zimmer Spine, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: May 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Trinica® Anterior Lumbar Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation 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, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous fusion.

Device Story

Trinica Anterior Lumbar Plate (ALP) System is a temporary supplemental fixation device for spinal stabilization and fusion. System comprises titanium alloy (Ti-6Al-4V ELI) plates, bone screws, and anti-migration locking caps. Used by surgeons in clinical settings to augment interbody devices; provides anterior lumbar stabilization. Components are anatomically designed for anterior or anterior-lateral approaches. Surgeon selects and configures plates/screws to individual patient anatomy; locking caps secure fixation. Device provides mechanical support to facilitate solid spinal fusion. Supplied with necessary instrumentation for implantation; single-use only.

Clinical Evidence

Bench testing only. Sterilization validation performed on the modified tray bracket per ISO 17665 and AAMI TIR12 requirements.

Technological Characteristics

Titanium alloy (Ti-6Al-4V ELI) plates, screws, and locking caps. Low-profile, anatomically designed plates. Mechanical fixation via screw-locking mechanism. Single-use. Sterilization validation per ISO 17665 and AAMI TIR12.

Indications for Use

Indicated for patients with lumbar or lumbosacral (L1-S1) spine instability due to fracture, tumor, degenerative disc disease, pseudoarthrosis, spondylolisthesis, scoliosis, lordotic deformities, spinal stenosis, or failed fusion. Used via lateral/anterolateral approach (above great vessel bifurcation) or anterior approach (below bifurcation).

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

• Trinica® Anterior Lumbar Plate System (K061353)

Submission Summary (Full Text)

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Page 1 of 2 K140611

Zimmer Spine 510(k) - Trinica ALP

510(k) Summary

MAY 2 1 20 %

## 510(k) SUMMARY

Trinica® Anterior Lumbar Plate System

March 07, 2014 Date of Summary Preparation: Submitter: Zimmer Spine, Inc. 7375 Bush Lake Road · Minneapolis, MN 55439 USA Establishment Registration Number: 2184052 (Minneapolis) Donna M. Semlak Company Contact (Primary): Senior Requlatory Affairs Specialist Email: [e-mail] Office: 952.857.5643 Email Fax: [phone] Trade Name(s): Trinica® Anterior Lumbar Plate System Device Name (Common Name): Spinal Intervertebral Body Fixation Orthosis Device Classification: Class II Requlation Number and 21 CFR § 888.3060 / KWQ Product Code(s): Predicate Devices: Trinica® Anterior Lumbar Plate System (K061353)

## General Device Description:

The Trinica® Anterior Lumbar Plate (ALP) System is a temporary supplemental fixation device consisting of a variety of shapes and sizes of plates and screws. The Trinica Anterior Lumbar Plate System is used as an implant for the correction and stabilization of the spine. This system provides temporary stabilization and augments the development of a solid spinal fusion. Additionally, this system provides the surgeon with the ability to supplement an interbody device with anterior plate fixation. The Trinica Anterior Lumbar Plate System components can be locked into a variety of configurations and each construct may be customized to individual cases. The plates are low profile and anatomically designed to provide optimal fit from either anterior or anterior-lateral approach. This system also features anti-migration locking caps to help secure the fixation screws. All Trinica Anterior Lumbar Plate System implant components are made from titanium alloy (Ti-6AI-4V ELI).

The Trinica Anterior Lumbar Plate System is supplied with the instrumentation necessary for implantation of the system. The Trinica" Anterior Lumbar Plate System is for single use only.

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510(k) Summary

## Indications for Use:

The Trinical Anterior Lumbar Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation 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, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous fusion.

## Summary of Technological Characteristics

The technological characteristics remain the same for the subject Trinica® Anterior Lumbar Plate System as the currently marketed (predicate) Trinica® Anterior Lumbar Plate System, which received FDA clearance K061353. There are no changes to the implants (plates and/or screws) and instrumentation within this submission is only addressing a sterilization tray bracket modification.

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

The Trinical Anterior Lumbar Plate System provides temporary supplemental fixation devices consisting of a variety of shapes and sizes of plates and screws: intended to provide anterior lumbar temporary stabilization and the development of a solid spinal fusion per the indications for use, as stated in the Section above.

Trinica® Anterior Lumbar Plate System includes: plates, bone screws with locking caps, and instrumentation necessary to implant this specific system. The Trinica Anterior Lumbar Plate System is for single use only.

## Summary of Performance Testing

Sterilization testing of the components/instruments contained in the subject Trinica ALPS tray were assessed and tested appropriately to design controls; i.e. sterilization validation. The test results demonstrated the modified device met the requirements of ISO 17665 and AAMI TIR12.

## Substantial Equivalence

Zimmer Spine considers the subject Trinica Anterior Lumbar Plate System to be substantially equivalent to the currently marketed Trinica Anterior Lumbar Plate System, K061353, as there are no changes to: the intended use, mechanical and functional performance, functional scientific technology, the implants (plates or screw) and/or instrumentation.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, rendered in black.

#### Public Health Service

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

May 21, 2014

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

K140611 Re:

> Trade/Device Name: Trinica® Anterior Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 7, 2014 Received: March 10, 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.

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.

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Page 2 - Ms. Donna M. Semlak

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" (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/MedicalDcvices/Safetv/ReportalProblem/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,

## Ronald P. Jean -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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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K140611

Device Name

Trinica® Anterior Lumbar Plate System

### Indications for Use (Describe)

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

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)

# Ronald P. Jean -S 2014.05.21 09:48:15 -04'00'

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