Medussa-PL Cage

K170341 · Medyssey USA, Inc. · MAX · Nov 2, 2017 · Orthopedic

Device Facts

• Record ID: K170341
• Device Name: Medussa-PL Cage
• Applicant: Medyssey USA, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Nov 2, 2017
• Decision: SESE
• Submission Type: Traditional
• 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

Intervertebral body fusion device; implanted via posterior lumbar intervertebral (PLIF) approach; provides mechanical stability in lumbar disc space to facilitate biologic fusion. Comprised of various implant sizes and instrumentation; manufactured via additive manufacturing technology. Used by surgeons in clinical settings to treat DDD. Output is physical structural support for spinal fusion; affects clinical decision-making by providing stabilization platform for bone graft. Benefits patient by facilitating fusion and reducing discogenic back pain.

Clinical Evidence

Bench testing only. Performed static/dynamic axial compression, compression shear, and torsion (ASTM F2077-14); subsidence (ASTM F2267-04); expulsion testing; and abrasion testing (ASTM F1978). Bone graft volume and SEM characterization also conducted.

Technological Characteristics

Titanium alloy Ti6Al4V-ELI (ASTM F136, ASTM F3001); additive manufacturing; intervertebral body fusion cage; single-use; provided sterile.

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 prior 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

• Medyssey LP Cage (K110067)
• 4-WEB ALIF SPINAL TRUSS SYSTEM (STS) (K112316)

Submission Summary (Full Text)

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November 2, 2017

Medyssey Co., Ltd. % Ms. Cheryl L. Wagoner Principal Consultant/Owner Wagoner Consulting LLC P.O. Box 15729 Wilmington, North Carolina 28408

Re: K170341

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: October 2, 2017 Received: October 4, 2017

Dear Ms. Wagoner:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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,

## Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K170341

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) | |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary (as required by 21 CFR 807.92)

| Date Prepared | 10/31/2017 |
|----------------|----------------------------------------------------------------------------------|
| Manufacturer | Medyssey Co., Ltd. |
| Address | 129, Hanbang Expo-ro, Jecheon-si, Chungcheongbuk-do, 27116,<br>Republic of Korea |
| Telephone | [phone] |
| Fax | [phone] |
| Contact Person | Shawn Kim |
| Address | Medyssey USA<br>1550 E Higgins Road<br>Suite#123<br>Elk Grove, IL 60007 |
| Telephone | 847-427-0200 |
| Fax | 888-518-9070 |
| email | [e-mail] |

| Trade Name | Medussa-PL Cage |
|---------------------|-----------------------------------|
| Common Name | Intervertebral Body Fusion Device |
| Panel Code | Orthopaedics/87 |
| Classification Name | Intervertebral Body Fusion Device |
| Class | Class II |
| Regulation Number | 21 CFR 888.3080 |
| Product Code | MAX |

| Name of Predicate Device | 510(k) # | Manufacturer |
|-----------------------------------------|----------|-------------------|
| Medyssey LP Cage (Primary) | K110067 | Medyssey Co., Ltd |
| 4-WEB ALIF SPINAL TRUSS<br>SYSTEM (STS) | K112316 | 4-WEB, INC. |

| Description | The Medussa-PL Cage is comprised of a variety of implant sizes and<br>instrumentation to accommodate various patient anatomy and pathology.<br>All implantable components are manufactured with an additive<br>manufacturing technology from medical grade titanium alloy Ti6Al4V-ELI<br>per ASTM F136 and ASTM 3001. The cages are intended to be<br>implanted via a Posterior Lumbar Intervertebral (PLIF) approach.<br>Implants are single use and the system is provided sterile. |
|-------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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

| Technological<br>Characteristics and<br>Substantial<br>Equivalence | Documentation was provided to demonstrate that the Subject device, Medussa-<br>PL Cage is substantially equivalent to the Predicate Medyssey LP Cage<br>(K110067). The Subject device is substantially equivalent to the predicate device<br>in intended use, indications for use, materials, technological characteristics, and<br>labeling. |
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| Performance Data | Static and dynamic axial compression, static and dynamic<br>compression shear, and static torsion were completed following<br>ASTM F2077-14. Subsidence was tested following ASTM F2267-<br>04. Expulsion was tested following a recognized protocol to allow<br>comparison evaluation of intervertebral body fusion device<br>assemblies, and characterize their resistance to expulsion.<br>Abrasion testing was performed per ASTM F1978. Additionally,<br>bone graft volume as compared to the predicate and SEM<br>characterization were conducted. The above pre-clinical testing on<br>the Subject device indicate that the Medussa-PL Cage is<br>substantially equivalent to the predicate device. |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | The Medussa-PL Cage and its predicate have the same intended use, to provide<br>mechanical stability in the lumbar disc space to facilitate biologic fusion. The<br>indications for use of the Medussa-PL Cage are identical to the predicate. The<br>Subject device is similar in size as its predicate. Minor differences between the<br>Subject and predicate devices do not raise any new questions of safety or<br>efficacy. Bench testing demonstrated that the differences do not adversely impact<br>device mechanical performance. Based on the intended use, indications for use,<br>technological characteristics, materials, and comparison to predicate devices, the<br>Subject Medussa-PL Cage (Subject device) has been shown to be substantially<br>equivalent to legally marketed predicate devices. |