Meridian Anterior Plate System, Regatta Lateral Plate System

K200885 · SeaSpine Orthopedics Corporation · KWQ · May 28, 2020 · Orthopedic

Device Facts

• Record ID: K200885
• Device Name: Meridian Anterior Plate System, Regatta Lateral Plate System
• Applicant: SeaSpine Orthopedics Corporation
• Product Code: KWQ · Orthopedic
• Decision Date: May 28, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Meridian Anterior Plate System is indicated as additional support during fusion via an anterior or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and 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 patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, or a failed previous spine surgery. The SeaSpine Regatta Lateral Plate System is indicated as additional support during fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via a lateral or anterolateral surgical approach below the bifurcation of the treatment of lumbar and 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 patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.

Device Story

Meridian Anterior Plate and Regatta Lateral Plate systems are spinal intervertebral body fixation orthoses. Devices consist of titanium alloy plates and fixation hardware. Used by surgeons during spinal fusion procedures via anterior, anterolateral, or lateral surgical approaches. Plates provide supplemental stabilization to the spine during the fusion process. Benefit to patient is enhanced structural support during healing of spinal instability caused by trauma, degeneration, or deformity. Devices are implanted in an OR setting.

Clinical Evidence

Bench testing only. Testing included static compression bending, static torsion, and dynamic compression bending per ASTM F1717 standards.

Technological Characteristics

Materials: Titanium alloy per ASTM F136. Components: Plates and fixation hardware. Principle: Spinal intervertebral body fixation orthosis. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients with thoracic, thoracolumbar, lumbar, or lumbosacral (T1-S1) spine instability requiring additional support during fusion. Conditions include fracture, tumor, degenerative disc disease, scoliosis, kyphosis/lordosis, spinal stenosis, or failed previous surgery.

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

• BodyForm Thoracic Fixation System (K072407)
• Cure Lumbar Plate System (K171538)

Submission Summary (Full Text)

{0}------------------------------------------------

May 28, 2020

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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

SeaSpine Orthopedics Corporation Ms. Aly Alvarez Sr. Specialist, Regulatory Affairs 5770 Armada Drive Carlsbad, California 92008

Re: K200885

Trade/Device Name: Meridian Anterior Plate System, Regatta Lateral Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 31, 2020 Received: April 2, 2020

Dear Ms. Alvarez:

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 (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Colin O'Neill, M.B.E. Acting 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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known)

#### K200885

Device Name Meridian Anterior Plate System

#### Indications for Use (Describe)

The Meridian Anterior Plate System is indicated as additional support during fusion via an anterior or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and 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 patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, or a failed previous spine surgery.

Type of Use (Select one or both, as applicable)

| <div> <span style="font-size:16px">✖</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|----------------------------------------------------------------------------------------------------|
| <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *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 [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

### Indications for Use

510(k) Number (if known)

K200885

Device Name Regatta Lateral Plate System

### Indications for Use (Describe)

The SeaSpine Regatta Lateral Plate System is indicated as additional support during fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T) -L5) spine instability or via a lateral or anterolateral surgical approach below the bifurcation of the treatment of lumbar and 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 patient history and radiographic studies), scoliosis, 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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

# 510(k) Summary

# Contact Details

| Applicant Name: | SeaSpine Orthopedics Corporation |
|-----------------|------------------------------------------------|
| Address: | 5770 Armada Drive, Carlsbad CA |
| Phone number: | [phone] |
| Fax number: | [phone] |
| Contact person: | Aly Alvarez, Sr. Regulatory Affairs Specialist |
| Date Prepared: | March 30, 2020 |

Device Name

| Trade Name: | 1. Meridian Anterior Plate System<br>2. Regatta Lateral Plate System |
|----------------------|----------------------------------------------------------------------|
| Common Name: | Appliance, fixation, spinal intervertebral body |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060) |
| Class: | II |
| Product Code: | KWQ |

## Legally Marketed Predicate Devices

| 510(k) Number | Product Code | Trade Name | Manufacturer |
|------------------------------|--------------|--------------------------------------|-------------------------------------------------------------------------|
| Primary Predicate Device | | | |
| K072407 | KWQ | BodyForm Thoracic Fixation<br>System | SeaSpine Orthopedics<br>Corporation<br>(previously Theken<br>Spine, LLC |
| Additional Predicate Devices | | | |
| K171538 | KWQ | Cure Lumbar Plate System | Meditech Spine, LLC |

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

## Device Description

The Meridian Anterior Plate and Regatta Lateral Plate Systems each consist of varying sizes of plates and fixation options that accommodate either anterior or lateral surgical approaches in the thoracic, lumbar, and sacral spine (T1-S1). Each plate is manufactured from titanium alloy per ASTM F136 and is designed to provide additional support during spinal fusion procedures.

## Intended Use/Indications for Use

### Meridian Anterior Plate

The Meridian Anterior Plate System is indicated as additional support during fusion via an anterior or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (11-51) 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, lordosis, spinal stenosis, or a failed previous spine surgery.

### Regatta Lateral Plate

The SeaSpine Regatta Lateral Plate System is indicated as additional support during fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via a lateral or anterolateral surgical approach below the bifurcation of the great vessels in the treatment of lumbar and 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 patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.

## Summary of Technological Characteristics

The Meridian Anterior Plate and Regatta Lateral Plate is equivalent to the predicate devices through comparison in regard to intended use, material, principles of operation, design and performance.

## Non-Clinical Testing

Nonclinical testing was performed to demonstrate that the proposed Meridian Anterior Plate and Regatta Lateral Plate systems are substantially equivalent to the cited predicate devices. The following testing and analysis were performed:

- Static Compression Bending (ASTM F1717)
- Static Torsion (ASTM F1717)
- Dynamic Compression Bending (ASTM F1717)

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

## Conclusions

The submitted data demonstrates that both the Meridian Anterior Plate and Regatta Lateral Plate are as safe, as effective, and perform at least as safely and effectively as the cited predicates. Minor differences in non-clinical test results do not impact device performance when compared to the legally marketed predicate devices.