Medussa-PL Cage

K200283 · Medyssey USA, Inc. · MAX · Jun 18, 2020 · Orthopedic

Device Facts

• Record ID: K200283
• Device Name: Medussa-PL Cage
• Applicant: Medyssey USA, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Jun 18, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medussa-PL Cage is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

Device Story

Medussa-PL Cage is an interbody fusion device for lumbar spine surgery. It facilitates fusion by providing structural support between vertebrae. The device is additively manufactured from titanium alloy and comes in various sizes to match patient anatomy. It is intended for use by surgeons in clinical settings. The device is used in conjunction with supplemental fixation and autograft bone to treat degenerative disc disease. It functions as a mechanical spacer to maintain disc height and promote bone growth.

Clinical Evidence

Bench testing only. Engineering CAD analyses were performed to compare device dimensions, materials, and design features against the predicate device.

Technological Characteristics

Intervertebral body fusion device; additively manufactured titanium alloy (ASTM F136 and ASTM F3001); various sizes available; mechanical spacer design.

Indications for Use

Indicated for skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1, including those with up to Grade 1 spondylolisthesis or retrolisthesis. Requires 6 months of failed non-operative treatment. Must be used with supplemental fixation and autograft bone.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Medussa-PL Cage (K170341)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 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.

June 18, 2020

Medyssey USA, Inc. % Justin Eggleton Vice President, Spine Regulatory Affairs MCRA, LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001

Re: K200283

Trade/Device Name: Medussa-PL Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 29, 2020 Received: April 29, 2020

Dear Mr. Eggleton:

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/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 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,

Brent Showalter, Ph.D. 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)

K200283

#### Device Name

Medussa-PL Cage

#### Indications for Use (Describe)

The Medussa-PL Cage is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

| 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.

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

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."

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

# 5. 510(k) Summary

| Device Trade Name: | Medussa-PL Cage |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Medyssey USA, Inc.<br>1550 E. Higgins Road, Suite 123<br>Elk Grove Village, IL 60007, USA<br>Phone: [phone] |
| Contact: | Mr. Shawn Kim<br>Director<br>Medyssey USA, Inc.<br>1550 E. Higgins Road, Suite 123<br>Elk Grove Village, IL 60007, USA |
| Prepared by: | Mr. Justin Eggleton<br>Vice President, Spine Regulatory Affairs<br>MCRA, LLC<br>1050 K Street NW, Suite 1000<br>Washington, DC 20001<br>[phone]<br>[e-mail] |
| Date Prepared: | February 4, 2020 |
| Classifications: | 21 CFR §888.3080, Intervertebral body fusion device |
| Class: | II |
| Product Codes: | MAX |
| Primary Predicate: | The subject devices are substantially equivalent to the<br>Medyssey Medussa-PL Cage (K170341). |

## Indications for Use and Intended Use:

The Medussa-PL Cage is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

## Device Description:

The Medyssey, Medussa-PL Cage is an interbody fusion device utilized to facilitate the fusion process in the lumbar spine. The cage is additively manufactured from titanium alloy

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

(ASTM F136 and ASTM F3001) and is available in a range of sizes to accommodate different patient anatomies and pathologies.

### Performance Testing Summary:

Engineering CAD analyses including a comparison of device dimensions and materials concluded that based on the similarities in device design, the subject and predicate devices are substantially equivalent with respect to performance since both products have the same dimensions, material, area and bone graft lumen capacity.

### Substantial Equivalence:

The subject Medussa-PL Cage is substantially equivalent to the primary predicate, the Medussa-PL Cage (K170341), with respect to indications, design, materials, function, and performance.