The KMTI Tesera-k SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-k SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation.

The KMTI Tesera-k SC System is a stand-alone system when used with the locking bolt and bone screws provided and requires no additional supplemental fixation. When used as a stand-alone system, the cages require the use of two (2) bone screws and the locking bolt.

When used without the locking bolt and two screws, the KMTI Tesera-k SC System is a non-standalone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability and may only be used at one level.

Device Description

The Tesera-k SC System (Tesera-k SC) is a spinal fusion system consisting of additively manufactured interbody devices and machined titanium bone screws and cage lock. It is designed to provide mechanical support to the cervical spine while arthrodesis occurs. The Tesera-k SC implants are available in a variety of lordosis and footprint options with a superior and inferior porous face and internal lattice structure to offer increased capacity for bone growth.

The Tesera-k SC cages are additively manufactured then machined from Titanium alloy (Ti-6Al-4V) per ASTM F2924 or are additively manufactured from Titanium alloy (Ti-6Al-4V ELI) per ASTM F3001, and the bone screws and cage locks are machined from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The Tesera-k SC System may be implanted as a standalone with two internal fixation screws and the cage lock and without supplemental fixation or may be implanted as a non-standalone system without the internal fixation screws or cage lock but with FDA-cleared supplemental fixation.

AI/ML Overview

The provided FDA 510(k) clearance letter for the Tesera-k SC System focuses on the substantial equivalence of an intervertebral body fusion device. Crucially, as this is a medical device clearance, the performance data provided relates primarily to mechanical testing of the device's structural integrity and does not involve clinical studies with human subjects or AI algorithms to interpret medical images.

Therefore, many of the requested sections (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone algorithm performance, AI training set details) are not applicable to this type of device clearance and the information provided.

Based on the provided document, here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter mentions the following non-clinical performance tests. It states that the "results of this non-clinical testing show that the strength of the Tesera-k SC System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." However, specific numerical acceptance criteria and precise reported device performance values are not detailed in this public summary document. The document only lists the types of tests performed.

Acceptance Criteria (Not explicitly stated numerically, but implied by "sufficient for intended use" and "substantially equivalent")	Reported Device Performance (Not explicitly stated numerically, but implied by "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices")
Mechanical Performance (Implied acceptance criteria: meet or exceed predicate device performance for intended use)	"sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." (Specific numerical results are not provided in this summary.)
Dynamic axial compression (per ASTM F2077)	Passed (implied)
Dynamic compression shear (per ASTM F2077)	Passed (implied)
Dynamic torsion (per ASTM F2077)	Passed (implied)
Tensile Strength (per ASTM F1147)	Passed (implied)
Shear Fatigue (per ASTM F1160)	Passed (implied)
Abrasion (per ASTM F1978)	Passed (implied)

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable in this context. The testing involved mechanical evaluation of the device as a physical product, not an AI algorithm on a dataset.
Data Provenance: Not applicable for AI data. The "performance data" refers to the results of standardized mechanical tests on the device, not clinical data or image data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the clearance is for a physical medical device (intervertebral fusion device), not an AI/software device that requires expert-established ground truth on medical images.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This question is not applicable for the same reasons as #3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable as the clearance is for a physical medical device, not an AI/software device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable as the clearance is for a physical medical device, not an AI/software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This question is not applicable. For this type of device, "ground truth" relates to the physical and material properties meeting engineering specifications and clinical performance criteria established through mechanical testing and comparison to predicates, rather than a diagnostic 'ground truth' from human interpretation or pathology.

8. The sample size for the training set

This question is not applicable as the clearance is for a physical medical device, not an AI/software device that requires a training set.

9. How the ground truth for the training set was established

This question is not applicable for the same reasons as #8.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the Tesera-k SC System meets acceptance criteria consists of a series of non-clinical mechanical tests designed to assess the device's structural integrity, durability, and resistance to various forces it would encounter in its intended use. These tests were conducted according to recognized ASTM standards.

The specific tests performed were:

Dynamic axial compression per ASTM F2077
Dynamic compression shear per ASTM F2077
Dynamic torsion per ASTM F2077
Tensile Strength per ASTM F1147
Shear Fatigue per ASTM F1160
Abrasion per ASTM F1978

Conclusion of the Study:
The document states that "The results of this non-clinical testing show that the strength of the Tesera-k SC System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This implies that the device successfully met the performance benchmarks implicitly required for devices of its type and demonstrated equivalent or superior performance to the predicate device, K223105 (Tesera-k SC System by Kyocera Medical Technologies, Inc.). The overall technological characteristics and mechanical performance data led to the conclusion of substantial equivalence.

Summary

FDA 510(k) Clearance Letter - Tesera-k SC System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

April 10, 2025

Kyocera Medical Technologies, Inc.
℅ Nathan Wright
Engineer & Regulatory Specialist
Empirical Technologies
4628 Northpark Drive
Colorado Springs, Colorado 80918
United States of America

Re: K242928
Trade/Device Name: Tesera-k SC System
Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral body fusion device
Regulatory Class: Class II
Product Code: ODP
Dated: March 17, 2025
Received: March 17, 2025

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 (the 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 available 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.

Page 2

K242928 - Nathan Wright
Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

Page 3

K242928 - Nathan Wright
Page 3

assistance/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 Showalter -S

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

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)
K242928

Device Name
Tesera-k SC System

Indications for Use (Describe)

Indications for Use

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."

Page 5

K242928 – 510(K) SUMMARY

1 | Page

Submitter's Name: Kyocera Medical Technologies, Inc. (KMTI)
Submitter's Address: 1289 Bryn Mawr Avenue, Suite A
Redlands, California 92374
Submitter's Telephone: 909-557-2360
Contact Person: Nathan Wright, MS, RAC
Empirical Technologies
1-719-351-0248
nwright@empiricaltech.com
Date Summary was Prepared: October 7, 2024
Trade or Proprietary Name: Tesera-k SC System
Device Classification Name: Intervertebral Fusion Device with Integrated Fixation, Cervical; Intervertebral Fusion Device with Bone Graft, Cervical
Classification & Regulation #: Class II per 21 CFR §888.3080
Product Code: OVE, MAX
Classification Panel: Orthopedic – Spinal (DHT6B)

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

Page 6

2 | Page

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 the same between the subject and predicates:

Indications for Use
Structure and Function
Mechanical strength
Cage Sizes
Screw Sizes

Predicate Devices

510k Number	Trade or Proprietary or Model Name	Manufacturer	Predicate Type
K223105	Tesera-k SC System	Kyocera Medical Technologies, Inc.	Primary

PERFORMANCE DATA

The subject device has been tested in the following test modes:

Dynamic axial compression per ASTM F2077
Dynamic compression shear per ASTM F2077
Dynamic torsion per ASTM F2077
Tensile Strength per ASTM F1147
Shear Fatigue per ASTM F1160
Abrasion per ASTM F1978

The results of this non-clinical testing show that the strength of the Tesera-k SC 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 SC 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.