Painful and disabled knee joint resulting from osteoarthritis, or idiopathic osteonecrosis, of . either the medial or lateral compartments.
Correction of varus, valgus, or posttraumatic deformity. .
As an alternative to tibial osteotomy in patients with unicompartmental NIDJD disease. .
Revision procedures where other treatments or devices have failed. ●
This device is intended for cemented use only.

Device Description

KMTI's TRIBRID® Unicompartmental Knee System is a partial knee replacement prostheses intended for application with bone cement. Partial knee replacement components include femoral and tibial components. Femoral baseplates are CoCrMo Alloy while the Tibial implants are Ti6Al4V Alloy. The Tibial bearing inserts are made from Ultra-High Molecular Weight Polyethylene (UHMWPE) variations. Components are available in a variety of designs and size ranges intended for both primary and revision applications.

AI/ML Overview

This document is a 510(k) summary for the Kyocera TRIBRID® Unicompartmental Knee System, a medical device. It focuses on mechanical, non-clinical performance data rather than AI/software performance. Therefore, many of the requested criteria related to AI device performance are not applicable.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating that its mechanical performance is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. The document does not provide specific quantitative pass/fail values as acceptance criteria; rather, it lists the types of tests performed and concludes that the results support substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category (Implicit from tests)	Reported Device Performance (Summary)
Mechanical Strength & Durability
Baseplate Fatigue (per ASTM F3140-17)	Results show sufficient strength for intended use.
Femoral Component Durability (per ASTM F3210-22)	Results show sufficient strength for intended use.
Intrinsic Stability Characteristics	Not specified quantitatively, but contributes to overall conclusion of substantial equivalence.
Modular Disassembly Characteristics (per ASTM F1814 and ASTM F2083)	Not specified quantitatively, but contributes to overall conclusion of substantial equivalence.
Range of Motion Assessment (per ASTM F2083)	Not specified quantitatively, but contributes to overall conclusion of substantial equivalence.
Simulated Wear (per ISO 14243-3)	Not specified quantitatively, but contributes to overall conclusion of substantial equivalence.
Overall Comparison to Predicate Devices	The overall technology characteristics and mechanical performance data lead to the conclusion that the TRIBRID® Unicompartmental Knee System is substantially equivalent to the predicate device.

Study Details (based on the provided document)

Since the document describes a mechanical device and its non-clinical performance testing rather than an AI/software device, many of the typical questions for AI acceptance criteria and studies (e.g., sample size for test set, data provenance, number of experts, MRMC studies, standalone performance) are not applicable.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in this summary. Mechanical tests typically use a small number of samples (e.g., 3-6 or more, depending on the standard) to demonstrate compliance with a standard or to compare to predicate devices.
- Data Provenance: Not applicable. This is in vitro mechanical testing, not human data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for mechanical testing is established by engineering specifications, material properties, and industry standards (e.g., ASTM, ISO), not by expert consensus on clinical data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is for mechanical testing, not interpretation of clinical imagery or data by experts. Test results are typically compared directly to standard requirements or predicate device performance.
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:
- Not applicable. This is a knee implant, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Mechanical Testing Standards: The "ground truth" for this type of device is compliance with industrial standards (e.g., ASTM, ISO) for mechanical properties, durability, and wear, and demonstrating substantial equivalence to predicate devices that have established safety and effectiveness through their historical use.
The sample size for the training set:
- Not applicable. This is non-clinical mechanical testing, not a machine learning model.
How the ground truth for the training set was established:
- Not applicable. As above, this is mechanical engineering testing.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 4, 2024

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

Re: K232114

Trade/Device Name: TRIBRID® Unicompartmental Knee System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee Joint Femorotibial Metal/Polymer Non-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSX Dated: March 7, 2024 Received: March 8, 2024

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 (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" (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).

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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.

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

Sincerely,

Peter G. Allen -S Allen -S
Digitally signed by Peter G.
Date: 2024.04.04 16:21:20
-04'00'

For: Lixin Liu, PhD Assistant Director DHT6A: Division of Joint Arthroplasty 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

510(k) Number (if known)

K232114

Device Name

TRIBRID® Unicompartmental Knee System

Indications for Use (Describe)

The Kyocera TRIBRID® Unicompartmental Knee System is indicated for use in patients with the following:

Painful and disabled knee joint resulting from osteoarthritis, or idiopathic osteonecrosis, of . either the medial or lateral compartments.
Correction of varus, valgus, or posttraumatic deformity. .
As an alternative to tibial osteotomy in patients with unicompartmental NIDJD disease. .
Revision procedures where other treatments or devices have failed. ●

This device is intended for cemented use only.

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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K232114 - 510(K) SUMMARY

Submitter's Name:	Kyocera Medical Technologies, Inc.
Submitter's Address:	1200 California StreetSuite 210Redlands, California 92374
Submitter's Telephone:	(979) 492-6848
Contact Person:	Nathan Wright MS, RACEmpirical Technologies1-719-351-0248nwright@empiricaltech.comImage: EMPIRICAL TECHNOLOGIES logo
Date Summary was Prepared:	April 2, 2024
Trade or Proprietary Name:	TRIBRID® Unicompartmental Knee System
Device Classification Name:	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented,Metal/Polymer
Classification & Regulation #:	Class II per 21 CFR §888.3520
Product Code:	HSX
Classification Panel:	Orthopedic

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

The Kyocera TRIBRID® Unicompartmental Knee System is indicated for use in patients with the following:

o Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis, or idiopathic osteonecrosis, of either the medial or lateral compartments.
Correction of varus, valgus, or posttraumatic deformity. ●
As an alternative to tibial osteotomy in patients with unicompartmental NIDJD disease. ●
Revision procedures where other treatments or devices have failed. ●

This device is intended for cemented use only.

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
Materials of manufacture ●
Structural support mechanism ●

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Predicate Devices

510k Number	Trade or Proprietary orModel Name	Manufacturer	ProductCode	Type
K190085	JOUNEY IIUnicompartmental Knee	Smith & Nephew, Inc.	HSX	Predicate
K183029	MOTO™ Lateral PartialKnee System	Medacta International SA	HSX	Reference Device
K190122	Renovis A200 PS KneeSystem	Revnovis (now KyoceraMedical Technologies, Inc.)	JWH, OIY	Reference Device

PERFORMANCE DATA

The TRIBRID® Unicompartmental Knee System has been tested in the following test modes:

Baseplate Fatigue Testing per ASTM F3140-17 ●
Intrinsic Stability Characteristics
Modular Disassembly Characteristics per ASTM F1814 and ASTM F2083 ●
Femoral Component Durability Testing per ASTM F3210-22 ●
Range of Motion Assessment per ASTM F2083 ●
Simulated Wear per ISO 14243-3

The results of this non-clinical testing show that the strength of the TRIBRID® Unicompartmental Knee 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 TRIBRID® Unicompartmental Knee System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.