The Kyocera Medical Technologies, Inc. (KMT) Tesera-k Anterior Lumbar Interbody Fusion (ALIF) System is indicated for interbody fusion procedures in skeletally mature patients with disc disease (DDD) in the lumbar spine at one or two contiguous levels from L2 to S1. DDD 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 Tesera-k ALIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of nonoperative treatment. The Tesera-k ALIF System implants are available in standalone (Tesera-k SA) and non-standalone (Tesera-k A) configurations.

Tesera-k SA ALIF cages are intended to be implanted from a direct anterior surgical approach only. Tesera-k SA ALIF cages are intended to be used with the coverplate and screws provided. Tesera-k SA ALIF assemblies (cage, screws, coverplate) that contain cages with lordotic angles less than 20° and use all four screws are standalone and require no supplemental fixation. Tesera-k SA ALIF assemblies (cage, screws, coverplate) that contain cages with lordotic angles greater than or equal to 20° or if the surgeon chose to use fewer than four screws are considered non-standalone and require supplemental fixation cleared by the FDA for use in the lumbosacral spine.

Tesera-k A ALIF cages are monolithic and do not interface or mate with any additional implants. Tesera-k A ALIF cages may be implanted from direct anterior or oblique insertion angle. Tesera-k A ALIF cages are non-standalone and require supplemental fixation cleared by the FDA for use in the lumbosacral spine.

Device Description

The Kyocera Medical Technologies, Inc. (KMT) Tesera-k Anterior Lumbar Interbody Fusion (ALIF) System implants support foraminal height and decompression between lumbar or lumbosacral vertebral bodies during spinal correction and fusion as well as reusable instruments to assist in endplate preparation and implantation. The Tesera-k ALIF System implants are available as a monolith without integrated fixation (Tesera-k A) or as a standalone with integrated fixation (Tesera-k SA) and are additively manufactured from Ti-6Al-4Vper ASTM F2924. The Tesera-k SA constructs includes screws and a coverplate manufactured from Ti-6Al-4V per ASTM F136 from the Tesera SA ALIF System (K193320, K131122, K140106, and K180502). The Tesera-k ALIF implants are sterile packaged and inserted via a direct anterior or oblique anterior surgical approach. The Tesera-k ALIF implants are offered in a variety of sizes and lordosis options to meet patient anatomical needs.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria and the study that proves the device meets the acceptance criteria for a medical device that uses AI. The document is an FDA 510(k) clearance letter and summary for a spinal interbody fusion device (Tesera-k ALIF System), which is a physical implant, not an AI or software-based device.

Therefore, I cannot provide details on:

A table of acceptance criteria and reported device performance (for AI).
Sample size and data provenance for a test set (for AI).
Number and qualifications of experts for ground truth (for AI).
Adjudication method (for AI).
Multi-reader multi-case (MRMC) comparative effectiveness study with AI.
Standalone AI performance.
Type of ground truth used (for AI).
Sample size for the training set (for AI).
How ground truth for the training set was established (for AI).

The document focuses on the mechanical performance data (static and dynamic axial compression, compression shear, and subsidence) for the physical implant as per ASTM standards, concluding that the Tesera-k ALIF System is substantially equivalent to predicate devices based on these non-clinical tests.

Summary

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

Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 7, 2022

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

Re: K212980

Trade/Device Name: Tesera-k ALIF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX Dated: December 16, 2021 Received: December 20, 2021

Dear Mr. 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

{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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Brent L. 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) K212980

Device Name Tesera-k ALIF System

Indications for Use (Describe)

The Kyocera Medical Technologies, Inc. (KMT) Tesera-k Anterior Lumbar Interbody Fusion (ALF) System is indicated for interbody fusion procedures in skeletally mature patients with disc disease (DDD) in the lumbar spine at one or two contiguous levels from L2 to S1. DDD 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 Tesera-k ALIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of nonoperative treatment. The Tesera-k ALIF System implants are available in standalone (Tesera-k SA) and non-standalone (Tesera-k A) configurations.

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

Prescription Use (Part 21 CFR 801 Subpart D)	☑
Over-The-Counter Use (21 CFR 801 Subpart C)	☐

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}------------------------------------------------

Submitter's Name:	Kyocera Medical Technologies, Inc.
Submitter's Address:	1200 California Street, Ste. 210Redlands, CA 92374
Submitter's Telephone:	(909) 557-2360
Contact Person:	Nathan Wright MSEmpirical Testing Corp.719-351-0248nwright@empiricaltech.comImage: Empirical Testing Corp. Logo
Date Summary was Prepared:	September 16, 2021
Trade or Proprietary Name:	Tesera-k ALIF System
Common or Usual Name:	Intervertebral body fusion device
Classification:	Class II per 21 CFR §888.3080
Product Code:	OVD, MAX
Classification Panel:	Orthopedic

K212980 510(K) SUMMARY

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

The Kyocera Medical Technologies, Inc. (KMTI) Tesera-k Anterior Lumbar Interbody Fusion (ALIF) System is indicated for interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) in the lumbar spine at one or two contiguous levels from L2 to S1. DDD 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 Tesera-k ALIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of nonoperative treatment. The Tesera-k ALIF System implants are available in standalone (Tesera-k SA) and non-standalone (Tesera-k A) configurations.

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

k SA ALIF assemblies (cage, screws, coverplate) that contain cages with lordotic angles greater than or equal to 20° or if the surgeon chose to use fewer than four screws are considered nonstandalone and require supplemental fixation cleared by the FDA for use in the lumbosacral spine.

Tesera-k A ALIF cages are monolithic and do not interface or mate with any additional implants. Tesera-k A ALIF cages may be implanted from direct anterior or oblique insertion angle. Teserak A ALIF cages are non-standalone and require supplemental fixation cleared by the FDA for use in the lumbosacral spine.

TECHNOLOGICAL CHARACTERISTICS

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
Technological characteristics ●
Materials of manufacture ●

510kNumber	Trade or Proprietary Name	Manufacturer	PredicateType
K193320	KMTI Tesera SA Anterior LumbarInterbody Fusion System	Kyocera MedicalTechnologies, Inc.	Primary
K200879	SeaSpine Meridian System	SeaSpine OrthopedicsCorporation	Additional
K190483	SPIRA Open Matrix ALIF	Camber Spine Technologies	Additional
K131612	AnyPlus ALIF PEEK Lumbar FusionCage	GS Medical	Additional
K092193	Spinal USA Intervertebral Body FusionDevice ALIF	Spinal USA	Additional
K183705	IdentiTi Porous Ti Interbody SystemALIF	Alphatec Spine, Inc.	Additional

Table 5-1 Predicate Devices

PERFORMANCE DATA

The Tesera-k ALIF System has been tested in the following test modes:

Static and dynamic axial compression per ASTM F2077
. Static and dynamic compression shear per ASTM F2077
Subsidence per ASTM F2267 ●

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

The results of this non-clinical testing show that the strength of the Tesera-k ALIF System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Tesera-k ALIF System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
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.(b)
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.