CAYMAN LP Plate System

K190584 · K2m, Inc. · KWQ · May 15, 2019 · Orthopedic

Device Facts

• Record ID: K190584
• Device Name: CAYMAN LP Plate System
• Applicant: K2m, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: May 15, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CAYMAN LP Plate System is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

Device Story

Non-load bearing spinal fixation system; consists of plates and screws for attachment to vertebral body. Used in lateral and anterior spinal fusion procedures; acts as preventative barrier to intervertebral cage movement; provides stabilization and buttressing of tissue in intervertebral space. Operated by surgeons in clinical settings. Device maintains relative position of weak bony tissue (allografts/autografts) to support fusion process.

Clinical Evidence

Bench testing only. Mechanical tests performed to evaluate the ability of the plates to resist migration or expulsion of graft material.

Technological Characteristics

Manufactured from Ti6Al4V per ASTM and ISO standards. System consists of plates and screws for vertebral body attachment. Non-load bearing design.

Indications for Use

Indicated for use in spinal fusion procedures to maintain relative position of weak bony tissue (allografts/autografts). Not for load-bearing indications.

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

• K2M CAYMAN Buttress Plate System (K080302)
• Innovasis Kestral Buttress Plate System (K181063)
• Stryker LITe Plate System (K142699)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 15, 2019

K2m, Inc. Mr. Casey Hinckley Regulatory Affairs Specialist 600 Hope Parkway, SE Leesburg, Virginia 20175

Re: K190584

Trade/Device Name: CAYMAN LP Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 5, 2019 Received: March 6, 2019

Dear Mr. Hinckley:

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

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

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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

### Indications for Use

510(k) Number (if known) K190584

Device Name CAYMAN LP Plate System

Indications for Use (Describe)

The CAYMAN LP Plate System is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. The device is not intended for load bearing indications.

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

| <span style="font-family: Arial;"> <svg height="15" width="15"> <rect height="15" style="fill:lightgrey;stroke-width:1;stroke:rgb(0,0,0)" width="15"></rect> <line style="stroke:rgb(0,0,0);stroke-width:2" x1="2" x2="13" y1="2" y2="13"></line> <line style="stroke:rgb(0,0,0);stroke-width:2" x1="13" x2="2" y1="2" y2="13"></line> </svg> Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial;"> <svg height="15" width="15"> <rect height="15" style="fill:lightgrey;stroke-width:1;stroke:rgb(0,0,0)" width="15"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

### 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}------------------------------------------------

##

# stryker

### 2 510(k) Summary

| 510(k) Summary: CAYMAN LP Plate System | |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | K2M, Inc. |
| Contact Person : | Casey Hinckley<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | March 5, 2019 |
| Trade Name: | CAYMAN LP Plate System |
| Common Name: | Appliance, fixation, spinal intervertebral body |
| Proposed Class: | Class II |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060) |
| Product Code: | KWQ |
| Predicate Devices: | Primary Predicate: K2M CAYMAN Buttress Plate System (K080302)<br><br>Additional Predicates: Innovasis Kestral Buttress Plate System (K181063),<br>and Stryker LITe Plate System (K142699) |
| Device Description: | The CAYMAN LP Plate System are non-load bearing devices, each consisting<br>of a plate and screw for attachment to the vertebral body. The plates are<br>designed to be used as additions to spinal fusion procedures from the lateral<br>and anterior approaches, forming a preventative barrier to intervertebral<br>cage movement.<br><br>Materials: The devices are manufactured from Ti6Al4V per ASTM and ISO<br>standards.<br><br>Function: The plates are designed to be used in a spinal fusion procedures to<br>provide stabilization and buttressing of tissue in the intervertebral space. |
| Intended Use: | The CAYMAN LP Plate System is intended for use in spinal fusion procedures<br>as a means to maintain the relative position of weak bony tissue such as<br>allografts or autografts. The device is not intended for load bearing<br>indications. |
| 510(k) Summary: CAYMAN LP Plate System | |
| Summary of the<br>Technological<br>Characteristics | The CAYMAN LP Plate System is considered substantially equivalent to other<br>legally marketed devices. They are similar in design, material, and<br>indications for use. |
| Summary of the<br>Performance Data | Nonclinical testing was performed to demonstrate that the CAYMAN LP Plate<br>System is substantially equivalent to its predicate devices.<br>Mechanical tests were performed to test the ability of the plates to resist<br>migration or expulsion of the graft material. |
| Conclusion | The CAYMAN LP Plate System has identical indication, technological<br>characteristics, and principles of operation as its predicates. The nonclinical<br>test results demonstrated that the new CAYMAN LP plate is mechanically<br>superior to the legacy CAYMAN Buttress Plate. The CAYMAN LP Plate<br>System was shown to be substantially equivalent to its predicate devices. |

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

K190584 - Page 2 of 2

Image /page/4/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The word is in all lowercase letters and is black. There is a horizontal line below the word.