The Kyocera Medical Technologies, Inc. (KMTI) Tesera-k PL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. KMTI Teresa-K PL System implants are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment prior to implantation. The KMTI Tesera-k PL System is a non-standalone system and is required to be used with additional supplemental fixation that have been cleared by the FDA for use in the lumbar spine.

The Kyocera Medical Technologies, Inc. (KMTI) Tesera-k XL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. KMTI Tesera-k XL System implants are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment prior to implantation. The KMTI Tesera-k XL System is a non-standalone system and is required to be used with additional supplemental fixation that have been cleared by the FDA for use in the lumbar spine.

Device Description

The Tesera-k Lumbar System (Tesera-k PL (Tk-PL) System and Tesera-k XL System (Tk-XL) System) consist of interbody fusion implants intended to provide stability and facilitate fusion in the lumbar spine.

The Tesera-k PL System implants are offered with straight or curved profiles to accommodate posterior or transforaminal surgical approaches. The Tesera-k PL implants are additively manufactured then machined from Titanium alloy (Ti-6Al-4V ELI) per ASTM F3001.

The Tesera-k XL System implants are offered in a straight profile for the direct lateral surgical approach. The Tesera-k XL cages are additively manufactured then machined from Titanium alloy (Ti-6A1-4V ELI) per ASTM F3001. The Tesera-k XL Bone Screws and Locking Assemblies are machined from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The Tesera-k PL and Tesera-k XL Systems are non-standalone systems and must be used in conjunction with FDA-cleared lumbosacral supplemental fixation.

AI/ML Overview

The provided FDA 510(k) summary does not contain the information requested regarding acceptance criteria and performance studies for a medical image analysis AI device.

The document describes a submission for the Tesera-k PL System and Tesera-k XL System, which are intervertebral body fusion devices (implants for spinal fusion surgery). This is a physical medical device, not a software or AI-driven diagnostic or image analysis tool.

Therefore, I cannot extract details about:

Acceptance criteria and reported device performance for an AI/software device: The document focuses on mechanical testing of spinal implants (e.g., static and dynamic compression, shear, subsidence, expulsion, tensile strength, fatigue, abrasion).
Sample size for test sets and data provenance: Not relevant to a mechanical implant test.
Number of experts and their qualifications for ground truth: Not relevant. Ground truth for an implant is typically physical measurements and engineering standards.
Adjudication method for test set: Not applicable.
Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable to a physical implant.
Standalone (algorithm only) performance: Not applicable.
Type of ground truth used (expert consensus, pathology, outcomes data): The ground truth for this device is based on standardized mechanical testing (e.g., ASTM standards) to demonstrate structural integrity and long-term performance under simulated physiological conditions.
Sample size for training set and how ground truth was established for the training set: Not applicable to a physical implant. The "training" for such a device is its design and manufacturing process, optimized through engineering principles and iterative testing against performance standards.

In summary, the provided text describes the regulatory filing for a physical medical implant, not an AI or software-based medical device. As such, it does not contain the information necessary to answer your prompt about acceptance criteria and study details for an AI-driven device.

Summary

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March 20, 2025

Image /page/0/Picture/1 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.

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

Re: K242771

Trade/Device Name: Tesera-k PL System and Tesera-k XL System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD Dated: February 21, 2025 Received: February 21, 2025

Dear Mr. 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 (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.

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"

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(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 OS 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 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-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 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 Rue"). 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-advicecomprehensive-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-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).

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Sincerely,

Katherine D. Kavlock -

for

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

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Indications for Use

Submission Number (if known)

K242771

Device Name

Tesera-k PL System and Tesera-k XL System

Indications for Use (Describe)

Tesera-k Lumbar System:

The Kyocera Medical Technologies, Inc. (KMTI) Tesera-k XL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. KMTI Tesera-k XL System implants arare to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment prior to implantation. The KMTI Tesera-k XL System is a non-standalone system and is required to be used with additional supplemental fixation that have been cleared by the FDA for use in the lumbar spine.

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)

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K242771 510(K) SUMMARY

Submitter's Name:	Kyocera Medical Technologies, Inc. (KMTI)
Submitter's Address:	1200 California Street, Suite 210Redlands, California 92374
Submitter's Telephone:	909-557-2360
Contact Person:	Nathan Wright, MS, RACEmpirical Technologies1-719-351-0248nwright@empiricaltech.comImage: Empirical Technologies logo
Date Summary was Prepared:	December 18, 2024
Trade or Proprietary Name:	Tesera-k PL System and Tesera-k XL System
Device Classification Name:	Intervertebral Fusion Device with Integrated Fixation, Lumbar
Classification & Regulation #:	Class II per 21 CFR §888.3080
Product Code:	MAX, OVD
Classification Panel:	Orthopedic - Spinal (DHT6B)

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Tesera-k PL and Tesera-k XL Systems are non-standalone systems and must be used in conjunction with FDA-cleared lumbosacral supplemental fixation.

INDICATIONS FOR USE

The Kyocera Medical Technologies, Inc. (KMTI) Tesera-k PL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. KMTI Teresa-K PL System implants are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment prior to implantation. The KMTI Tesera-k PL System is a nonstandalone system and is required to be used with additional supplemental fixation that have been cleared by the FDA for use in the lumbar spine.

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standalone system and is required to be used with additional supplemental fixation that have been cleared by the FDA for use in the lumbar spine.

TECHNOLOGICAL CHARACTERISTICS

The predicates included in this submission were selected based on the best practices described in the FDA Draft Guidance document Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission. 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
Materials of Manufacture ●
Sterility
. Sizes

Predicate Devices

510k	Trade or Proprietary or Model Name	Manufacturer	Product Code	Predicate
Number				Type
K172816	TiGer Shark System	Choice Spine, LP	MAX	Primary
K133614	Aleutian IBF System	K2M, Inc.	MAX, MQP, ODP	Additional
K172341	NuVasive Modulus TLIF Interbody System	NuVasive, Inc.	MAX, PHM	Additional
K181655	Renovis S180 Lateral Lumbar Interbody System	Renovis Surgical Technologies	MAX	Additional
K212980	Tesera-k ALIF System	Kyocera Medical Technologies, Inc.	MAX, OVD	Additional

Performance Data

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

ASTM F2077 Static Axial Compression .
ASTM F2077 Dynamic Axial Compression ●
ASTM F2077 Static Compression Shear ●
ASTM F2077 Dynamic Compression Shear ●
ASTM F2267 Subsidence ●
Expulsion ●
. ASTM F1147 Tensile Strength
ASTM F1160 Shear Fatigue ●
ASTM F1978 Abrasion .

The results of this non-clinical testing show that the strength of the Tesera-k XL Systems are sufficient for their intended use and are substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Tesera-k PL and Tesera-k XL Systems are substantially equivalent to the predicate devices.

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.