CONDUIT Lateral Switch Plate

K221325 · Medos International SARL · MAX · Aug 25, 2022 · Orthopedic

Device Facts

• Record ID: K221325
• Device Name: CONDUIT Lateral Switch Plate
• Applicant: Medos International SARL
• Product Code: MAX · Orthopedic
• Decision Date: Aug 25, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used with or without the CONDUIT™ Lateral Switch Plate, the EIT Cellular Titanium® LLIF Cage is indicated for use with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine. The EIT Cellular Titanium® LLIF Cage with a microscopic roughened surface and micro and nano-scale features is indicated for intervertebral body fusion procedures 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. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneve bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

Device Story

CONDUIT™ Lateral Switch Plate is an optional spinal implant component; connects EIT Cellular Titanium® LLIF Cage to adjacent vertebral bodies using DePuy Synthes AEGIS Screws. Provides additional migration resistance and stability to the cage construct. Not considered supplemental fixation. Supplied sterile in one- or two-hole configurations. Used by surgeons in spinal fusion procedures to stabilize the lumbar spine. Benefits patient by enhancing construct stability during intervertebral body fusion.

Clinical Evidence

Bench testing only. Mechanical testing included dynamic/static axial compression and compression shear (ASTM F2077-18), subsidence analysis (ASTM F2267-04), and expulsion analysis. Biological evaluation performed per ISO 10993-1:2018. MRI safety testing performed per ASTM F2052-15, F2182-17, F2119-07, and F2182-19e2.

Technological Characteristics

Materials: ASTM F136 titanium alloy (Ti-6Al-4V ELI). Form factor: One- and two-hole plate configurations. Sterilization: Supplied sterile. No energy source or software components.

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 at least 6 months of prior non-operative treatment.

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

• Nuvasive Modulus XLIF (K192760)
• EIT Cellular Titanium® Lumbar Cage LLIF (K181644)
• EIT Cellular Titanium® Cervical Cage (K201605)

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.

August 25, 2022

Medos International, SARL % LiJuan He Associate Director, Regulatory Affairs DePuy Spine 325 Paramount Dr. Raynham, Massachusetts 02767

Re: K221325

Trade/Device Name: CONDUIT™ Lateral Switch Plate Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD Dated: July 27, 2022 Received: July 28, 2022

Dear LiJuan He:

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

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

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 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,

Brent Showalter, Ph.D. 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) K221325

Device Name CONDUIT™ Lateral Switch Plate

#### Indications for Use (Describe)

When used with or without the CONDUIT™ Lateral Switch Plate, the EIT Cellular Titanium® LLIF Cage is indicated for use with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine.

The EIT Cellular Titanium® LLIF Cage with a microscopic roughened surface and micro and nano-scale features is indicated for intervertebral body fusion procedures 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. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneve bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: line-through;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </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 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}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the DePuy Synthes logo. The logo consists of a red figure-eight-like symbol on the left, followed by the words "DePuy Synthes" in gray. Below the company name, it says "THE ORTHOPAEDICS COMPANY OF" in smaller gray font, followed by "Johnson & Johnson" in red script.

## 510(K) SUMMARY

| A. | Submitter Information | |
|----|------------------------------------------|---------------------------------------------------------------------------------------------------------|
| | Manufacturer: | Medos International SARL<br>Chemin-Blanc 38<br>2400 Le Locle, Switzerland |
| | Submitter: | DePuy Synthes Spine<br>325 Paramount Drive<br>Raynham, MA 02767 |
| | Contact Person:<br>Telephone:<br>Email: | LiJuan He<br>978-406-7629<br>[e-mail] |
| B. | Date Prepared | August 19, 2022 |
| C. | Device Name | |
| | Trade/Proprietary Name: | CONDUIT™ Lateral Switch Plate |
| | Device Classification<br>and Regulation: | Class II per 21 CFR §888.3080 |
| | Product Codes: | MAX, OVD |
| D. | Predicate Device Names | |
| | Primary Predicate: | Nuvasive Modulus XLIF (K192760) |
| | Additional Predicate: | EIT Cellular Titanium® Lumbar Cage LLIF<br>(K181644); EIT Cellular Titanium® Cervical<br>Cage (K201605) |
| | | |

# E. Device Description Summary

The CONDUIT™ Lateral Switch Plate ("Plate") is an optional device that connects to the EIT Cellular Titanium® LLIF Cage ("Cage") and adjacent vertebral body(s) to provide additional migration resistance and stability via DePuy Synthes AEGIS Screws ("Screws"). The subject device is not considered to be supplemental fixation. Both the Plate and Screws are manufactured from ASTM F136 titanium alloy (Ti-6A1-4V ELI). The Plate is supplied sterile in one- and two-hole configurations in a variety of sizes to attach to one or both adjacent vertebral bodies.

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

Image /page/4/Picture/1 description: The image shows the logo for DePuy Synthes, a company that specializes in orthopedics. The logo features a red abstract symbol on the left, followed by the company name in gray, with the words "THE ORTHOPAEDICS COMPANY OF" in smaller gray font underneath. Below that is the Johnson & Johnson logo in red script.

## F. Indented Use/Indications for Use

When used with or without the CONDUIT™ Lateral Switch Plate, the EIT Cellular Titanium® LLIF Cage is indicated for use with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine.

The EIT Cellular Titanium® LLIF Cage with a microscopic roughened surface and micro and nano-scale features is indicated for intervertebral body fusion procedures 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. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

### G. Indications for Use Comparison

The subject device (Plate) with the EIT Cellular Titanium® Lumbar LLIF Cage and screws comprise an implant system which has indications for use similar to those of the predicate devices.

### F. Non-Clinical Test Summary and Conclusions

- 1. Mechanical Testing
The following tests and analyses were performed on the subject device system to demonstrate that the CONDUIT™ Lateral Switch Plate is substantially equivalent to other predicate devices:

- · Dynamic Axial Compression (ASTM F2077-18)
- · Dynamic Compression Shear (ASTM F2077-18)
- · Static Axial Compression analysis (ASTM F2077-18)
- · Static Compression Shear analysis (ASTM F2077-18)
- · Subsidence analysis (ASTM F2267-04)
- Expulsion analysis
- 2. The subject devices were evaluated and tested in accordance with ISO 10993-1:2018, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process. The results demonstrate the subject devices comply with the applicable requirements of ISO 10993-1:2018
- 3. MRI Safety Testing per ASTM F2052-15, ASTM F2182-17, ASTM F2119-07 and ASTM F2182-19e2

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

Image /page/5/Picture/1 description: The image shows the logo for DePuy Synthes, The Orthopaedics Company of Johnson & Johnson. The logo features a red symbol resembling a stylized spine or interconnected loops on the left. To the right of the symbol is the company name "DePuy Synthes" in a bold, gray sans-serif font. Below the company name, in a smaller font, is the text "THE ORTHOPAEDICS COMPANY OF" followed by "Johnson & Johnson" in a red, cursive script.

The subject device is substantially equivalent to legally marketed predicate devices with respect to indications for use, design, function, material composition, and performance testing per testing standards.