Centerpiece Plate Fixation System

K212428 · Medtronic Sofamor Danek · NQW · Dec 13, 2021 · Orthopedic

Device Facts

• Record ID: K212428
• Device Name: Centerpiece Plate Fixation System
• Applicant: Medtronic Sofamor Danek
• Product Code: NQW · Orthopedic
• Decision Date: Dec 13, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CENTERPIECE™ Plate Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The CENTERPIECE™ Plate Fixation System is used to hold the graft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.

Device Story

The CENTERPIECE™ Plate Fixation System consists of titanium or titanium alloy plates and screws used in spinal laminoplasty. The system is implanted by a surgeon to secure graft material within the lower cervical and upper thoracic spine (C3 to T3). By holding the graft in place, the device prevents graft expulsion and spinal cord impingement, thereby supporting spinal stability and fusion. The system is provided in various sizes, with screws available in both sterile and non-sterile formats.

Clinical Evidence

Bench testing only. Performance data included static compression testing to compare screw-plate constructs, MRI safety evaluation, and engineering rationale for pull-out strength.

Technological Characteristics

Constructed from medical-grade titanium or titanium alloy. System comprises various sizes of plates and screws. Designed for spinal interlaminal fixation. Provided sterile and non-sterile; reusable components.

Indications for Use

Indicated for patients undergoing laminoplasty procedures in the lower cervical and upper thoracic spine (C3 to T3) to secure graft material and prevent expulsion or spinal cord impingement.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• CENTERPIECE™ Plate Fixation System (K050082)

Submission Summary (Full Text)

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

December 13, 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Medtronic Sofamor Danek Diamond Wallace Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K212428

Trade/Device Name: CENTERPIECE™ Plate Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: Class II Product Code: NQW Dated: November 8, 2021 Received: November 10, 2021

Dear Diamond Wallace:

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

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

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 mediation-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,

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

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

# Indications for Use

510(k) Number (if known)

K212428

### Device Name CENTERPIECE™ Plate Fixation System

### Indications for Use (Describe)

The CENTERPIECE™ Plate Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The CENTERPIECE™ Plate Fixation System is used to hold the graft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.

| Type of Use (Select one or both, as applicable) |
|------------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;"></span> 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."

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

# 510(k) SUMMARY

# November 5th, 2021

- I. Company: Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis, TN 38132 Telephone Number: [phone]
- Contact: Diamond Wallace Regulatory Affairs Specialist Telephone number: [phone] Email: [e-mail]

#### II. Proprietary Trade Name: CENTERPIECE™ Plate Fixation System

Common Name: Appliance, Fixation, Interlaminal Classification Name: 21 CFR 888.3050 - Spinal interlaminal fixation orthosis

Classification: Class II

Product Code: NQW

#### III. Predicate Devices:

Primary Predicate: CENTERPIECE™ Plate Fixation System (K050082, S.E. 06/06/2005)

The predicate devices have not been subject to a design-related recall.

#### IV. Device Description:

The CENTERPIECE™ Plate Fixation System consists of a variety of sizes of plates and screws. The CENTERPIECE™ Plate Fixation System screws are made of from medical grade titanium or titanium alloy. Screws will be provided sterile and non-sterile and are reusable.

#### V. Indications for Use:

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

The CENTERPIECE™ Plate Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The CENTERPIECE TM Plate Fixation System is used to hold the graft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.

#### VI. Comparison of the Technological Characteristics with the Predicate Device:

CENTERPIECE™ Plate Fixation System has the same fundamental scientific technology; indications for use, intended use, design, material levels of attachment as the predicate device. The predicate and subject devices are intended to restore spine stability and improve fusion.

#### Performance Data: VII.

Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. The following table summarizes the performance testing completed:

| Test | Description |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Static<br>Compression | The purpose of this testing was to compare the static compression<br>properties of the CENTERPIECE™ subject and predicate screw-<br>plate constructs. A compressive load was applied to the construct<br>in the posterior to anterior direction to simulate in vivo loading<br>conditions. |
| MRI Safety<br>Evaluation | The purpose of this testing was to evaluate the MRI safety of the<br>CENTERPIECE™ Plate Fixation System. |
| Pull Out Strength<br>Evaluation | The purpose of this engineering rationale was to address pullout<br>strength testing of the CENTERPIECE™ Plate Fixation System. |

#### VIII. Conclusions

The CENTERPIECE™ Plate Fixation System implants have shown through comparison and testing to be substantially equivalent to the identified predicate devices.