KMTI S141 Lumbar Interbody Fusion System

K212070 · Kyocera Medical Technologies, Inc. · MAX · Aug 30, 2021 · Orthopedic

Device Facts

• Record ID: K212070
• Device Name: KMTI S141 Lumbar Interbody Fusion System
• Applicant: Kyocera Medical Technologies, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Aug 30, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KMTI S141 Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). KMTI S141 System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The KMTI S141 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

Device Story

Intervertebral body fusion system consisting of cages inserted between lumbar/lumbosacral vertebral bodies; provides structural support/correction during fusion. Implants include Tesera-P, Tesera-T, PEEK Straight TLIF, and PEEK TLIF families. Titanium alloy implants feature porous structure for osseous integration; PEEK implants feature teeth for migration prevention and tantalum markers for radiographic visualization. Hollow geometry allows packing with autogenous bone graft. Used in open or minimally invasive surgical approaches by orthopedic/neurosurgeons. Implants provide mechanical stability to facilitate fusion; benefit includes stabilization of degenerated spinal segments.

Clinical Evidence

Bench testing only. Mechanical testing was conducted to demonstrate that modifications provide adequate and substantially equivalent mechanical strength compared to the predicate device.

Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F136), Ti-6Al-4V (ASTM F2924), PEEK (ASTM F2026), Tantalum (ASTM F560). Design: Hollow cages with porous titanium structures or PEEK teeth. Sterilization: Gamma irradiation. Connectivity: None.

Indications for Use

Indicated for skeletally mature patients with lumbar degenerative disc disease (DDD) at one or two contiguous levels (L2-S1) with up to Grade 1 spondylolisthesis or retrolisthesis. Requires six months of failed non-operative treatment; must be used with autogenous bone graft and supplemental lumbar fixation.

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

• Renovis S141 Lumbar Interbody Fusion System (K170888, K143126)
• Renovis S180 Lateral Lumbar Interbody Fusion System (K181655)
• ShurFit 2C Lumbar Interbody Fusion System (K171657)
• TM Ardis® Interbody System (K113561)
• EIT Cellular Titanium® TLIF Cage (K201605)

Submission Summary (Full Text)

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August 30, 2021

Kyocera Medical Technologies, Inc. % Nathan Wright, M.S. Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K212070

Trade/Device Name: KMTI S141 Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 20, 2021 Received: August 23, 2021

Dear Nathan Wright:

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

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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 medical devices and radiation-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

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# 4. INDICATIONS FOR USE STATEMENT

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

### Indications for Use

510(k) Number (if known)

K212070

Device Name

Kyocera Medical Technologies, Inc. (KMTI) S141 Lumbar Interbody Fusion System Indications for Use (Describe)

The KMTI S141 Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1.

Deqenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). KMTI S141 System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The KMTI S141 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

| Type of Use (Select one or both, as applicable) | <span> <span style="padding-right: 20px;"> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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| Submitter's Name: | Kyocera Medical Technologies, Inc. |
|----------------------------|------------------------------------------------------------------------------------------|
| Submitter's Address: | 1200 California St, Suite 210<br>Redlands, CA 92374 |
| Submitter's Telephone: | 909-557-2360 |
| Contact Person: | Nathan Wright MS<br>Empirical Testing Corp.<br>719-351-0248<br>[e-mail] |
| Date Summary was Prepared: | July 1, 2021 |
| Trade or Proprietary Name: | KMTI S141 Lumbar Interbody Fusion System |
| Common or Usual Name: | Intervertebral body fusion device |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | MAX |
| Classification Panel: | Orthopedic Devices |

# 510(K) SUMMARY

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Kyocera Medical Technologies, Inc. (KMTI) KMTI S141 Lumbar Interbody Fusion System (also called S141 LIF System) consists of cages which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion. The S141 LIF System includes the Tesera-P, Tesera-T, PEEK Straight TLIF, and PEEK TLIF families. The implants are offered in additively manufactured Titanium Alloy (Titanium-6Aluminum-4Vanadium) per ASTM F2924 and PEEK (Polyetheretherketone) per ASTM F2026.This submission updates the subject titanium alloy material specifications and standards, modifies the additive printing process, and expands the for the previously cleared S141 Lumbar Interbody Fusion System.

The KMTI S141 Lumbar Interbody Fusion System is comprised of a variety of implant sizes to accommodate various patient anatomy and pathology, and associated instrumentation. The implants may be inserted via an open or minimally invasive approach. The Tesera P and PEEK PLIF use a posterior approach. The PEEK Straight TLIF, Tesera ST, and Tesera T use an oblique approach. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The superior and inferior surfaces of the Titanium Alloy implant consist of Tesera porous titanium structure to facilitate osseous integration. The superior and inferior surfaces of the S141 PEEK devices have "teeth" to help prevent the device from migration after surgically positioned. Additionally, the S141 PEEK devices contain tantalum markers (per ASTM F560) to assist the surgeon with proper placement of the device. The implants are provided terminally sterilized via gamma irradiation prior to end-user receipt.

INDICATIONS FOR USE

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The KMTI S141 Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1.

Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). KMTI S141 System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The KMTI S141 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

The indications for use for the KMTI LIF System are identical to those of the primary predicate.

## TECHNICAL CHARACTERISTICS

The purpose of this system is to expand the product line of the KMTI S141 Lumbar Interbody Fusion System with additional sizes offered and to modify the material and manufacturing method for the KMTI S141 devices which were previously cleared. The KMTI S141 Lumbar Interbody Fusion System is made from Ti-6A1-4V ELI per ASTM F136 or Ti-6Al-4V per F2924 or from PEEK per ASTM F2026 with tantalum per ASTM F560. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:

- Indications for Use ●
- Structural support mechanism ●
- Sizes ●

| 510k Number | Trade or Proprietary or Model<br>Name | Manufacturer | Predicate<br>Type |
|------------------|--------------------------------------------------------|---------------------------------------------|-------------------|
| K170888, K143126 | Renovis S141 Lumbar Interbody<br>Fusion System | Renovis Surgical<br>Technologies | Primary |
| K181655 | Renovis S180 Lateral Lumbar<br>Interbody Fusion System | Renovis Surgical<br>Technologies | Additional |
| K171657 | ShurFit 2C Lumbar Interbody<br>Fusion System | Precision Spine, Inc. | Additional |
| K113561 | TM Ardis® Interbody System | Zimmer Trabecular<br>Metal Technology, Inc. | Additional |
| K201605 | EIT Cellular Titanium® TLIF Cage | EIT Emerging Implant<br>Technologies GmbH | Additional |

### Table 5-1 Predicate Devices

## PERFORMANCE TESTING SUMMARY

In support of this Special 510(k) Device Modification Premarket Notification, Kyocera Medical Technologies, Inc. has conducted mechanical testing to demonstrate that the modifications to the

Kyocera Medical Technologies, Inc. S141 Lumbar Interbody Fusion System

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S141 Lumbar Interbody Fusion System provide adequate and substantially equivalent mechanical strength for their intended use.

### CONCLUSION

The subject modified KMTI S141 Lumbar Interbody Fusion System is very similar to previously cleared Renovis S141 Lumbar Interbody Fusion System. The subject KMTI S141 Lumbar Interbody Fusion System has similar intended uses, indications, technological characteristics, and principles of operation as the predicate devices. The modifications raise no new types of safety or effectiveness questions. The overall technology characteristics and mechanical performance data lead to the conclusion that the KMTI S141 Lumbar Fusion System is substantially equivalent to the predicate devices.