Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis where one or more compartments are involved.
Correction of varus, valgus, or posttraumatic deformity.
Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

This device is for cemented use only.

Device Description

The Kyocera Medical Technologies, Inc. (KMTI) Initia Knee System is a patellofemorotibial polymer/ metal/polymer semi-constrained prosthesis intended to replace a knee joint. The system consists of femoral, tibial and patella components intended for use with bone cement. The Initia Knee System includes both posterior-stabilizing (PS) and cruciate-retaining (CR) designs.

AI/ML Overview

This document is a 510(k) summary for the Kyocera Medical Technologies, Inc. (KMTI) Initia Knee System. It details the device, its intended use, and its substantial equivalence to a predicate device, the KMTI A200 Knee System.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with specific pass/fail values. Instead, it lists various non-clinical performance tests that were conducted and states that the results were "acceptable." The implication is that the performance of the Initia Knee System met the requirements established for these tests, likely aligned with the standards cited.

Performance Test / Acceptance Criteria Category	Reported Device Performance (Implied)
Tibial Post Fatigue Strength (static and fatigue)	Acceptable
Tibial Tray Locking Mechanism	Acceptable
Tibial-Femoral Constraint	Acceptable
Tibial-Femoral Contact Area/Contact Stress	Acceptable
Femoral Fatigue	Acceptable
Patello-Femoral Lateral Subluxation and Contact Area/Contact Stress	Acceptable
Compliance with Consensus Standards (listed below)	Compliant
Functional Equivalence to Predicate Device	Demonstrated Substantial Equivalence

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: The document does not specify the exact sample sizes used for each individual non-clinical performance test. It mentions "components" and "trials" which implies multiple units were tested per category.
Data Provenance: The data is generated from non-clinical performance tests conducted by Kyocera Medical Technologies, Inc. ("KMTI"). The provenance is therefore internal testing by the manufacturer. The document does not specify the country of origin of the data beyond the manufacturer's location in Redlands, CA, USA. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate device performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This section is not applicable as the document describes non-clinical performance testing for a medical device (knee prosthesis), not an AI/software device that requires expert-established ground truth for a test set. The "ground truth" for these tests are the established engineering principles, material science properties, and consensus standards (e.g., ASTM, ISO) that define acceptable performance for orthopedic implants.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as point 3. Performance is evaluated against objective engineering criteria and consensus standards, not through expert adjudication of subjective interpretations.

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 section is not applicable. The subject device is a physical knee prosthesis, not an AI or software-based diagnostic or assistive tool. Therefore, a MRMC study involving human readers and AI assistance would not be relevant.

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

This section is not applicable. The subject device is a physical knee prosthesis, not an algorithm or software. No standalone algorithm performance was assessed for this device.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" is based on:

Established engineering principles and biomechanical requirements: These tests assess the physical and mechanical properties of the device.
Consensus standards: The document explicitly lists numerous ASTM and ISO standards (e.g., ASTM F1672-14 for patellar prosthesis, ASTM F1800-12 for tibial tray fatigue, ISO 7207-2 for articulating surfaces). These standards define test methodologies and acceptable performance metrics, which serve as the "ground truth" for assessing device safety and effectiveness.
Comparison to predicate device: The fundamental basis of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device. Therefore, the predicate's known safe and effective performance also acts as a reference for the "ground truth" of what is considered acceptable.

8. The Sample Size for the Training Set

This section is not applicable. The subject device is a physical knee prosthesis. There is no concept of a "training set" as there would be for an AI/machine learning model. The design and manufacturing process are informed by established engineering knowledge and previous experience with similar devices.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the same reasons as point 8.

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 is the Department of Health & Human Services logo. To the right of that 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.

January 13, 2024

Kyocera Medical Technologies, Inc. % Audrey Swearingen Regulatory Consultant Swearingen Regulatory Consulting, LLC 16856 Circle Hill Drive Dexter, Missouri 63841

Re: K243295

Trade/Device Name: Initia Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, OIY Dated: October 18, 2024 Received: October 18, 2024

Dear Audrey Swearingen:

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.

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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 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 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-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 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-regulatory

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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,

Peter G.
Allen -S
Digitally signed by
Peter G. Allen -S
Date: 2025.01.13
09:50:47 -05'00'

Lixin Liu, Ph.D. For 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

Submission Number (if known)

K243295

Device Name

Initia Knee System

Indications for Use (Describe)

The Initia Knee System is intended for use in total knee arthroplasty for the following indications:

Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis where one or more compartments are involved.
Correction of varus, valgus, or posttraumatic deformity.
Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

This device is 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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510(k) Summary

Initia Knee System

1. Submission Sponsor

Kyocera Medical Technologies, Inc. ('KMTI') 1200 California Street Suite 210 Redlands, CA 92374 Contact: Anthony DeBenedictis Title: DVP of Quality Assurance Phone: 1-909-557-2360 ext. 451 Email: anthony.debenedictis@kyocera.com

2. Submission Correspondent

Swearingen Regulatory Consulting, LLC 16856 Circle Hill Drive Dexter, MO 63841 Contact: Audrey Swearingen Title: Senior Regulatory Consultant Phone: (512) 818-3811 Email: audrey@swearingenregconsulting.com

3. Date Prepared

October 18, 2024

4. Device Identification

Trade/Proprietary Name:	Initia Knee System
Classification Name:	Knee joint patellofemorotibial polymer/metal/polymer semi-constrainedcemented prosthesis
Regulation Number:	888.3560
Product Codes:	JWH, OIY
Class:	II
Classification Panel:	Orthopedic

5. Legally Marketed Predicate Device

Device name:	A200 Knee System
510(k) number:	K120038, K190122
Manufacturer:	Kyocera Medical Technologies, Inc.; previously Renovis Surgical TechnologiesLLC

Like the KMTI Initia Knee System, the A200 Knee System predicate device is a patellofemorotibial polymer/ metal/polymer semi-constrained prosthesis to replace a knee joint. The system consists of femoral, tibial and patella components intended for use with bone cement and includes both posterior-stabilizing (PS) and cruciate-retaining (CR) designs.

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6. Indication for Use Statement

The Initia Knee System is intended for use in total knee arthroplasty for the following indications:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis where one or more compartments are involved.
1. Correction of varus, valgus, or posttraumatic deformity.
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

This device is intended for cemented use only.

7. Device Description

Femoral Components

Eleven (11) sizes in CR design and 11 sizes in PS design (a total of 22 components), and for left and right sides in both designs. The femoral components are manufactured from Co-Cr-Mo alloy.

Tibial Baseplate Components

Ten (10) sizes in a keeled design, manufactured from Ti-6Al-4V alloy.

Tibial Insert Components

Seven (7) sizes of CR design and 7 sizes of PS design. The inserts will be offered in three (3) polyethylene materials: conventional UHMWPE (GUR1020), highly cross-linked UHMWPE without vitamin E, and cross-linked UHMWPE with vitamin E added.

Patella Components

Seven (7) sizes in domed, pegged design, also manufactured from conventional UHMWPE, cross-linked UHMWPE without vitamin E, and cross-linked UHMWPE with vitamin E added.

Instrumentation

Consists of general orthopedic surgical instruments for use with the system components, trial implant components, and general instruments. Most are manufactured of common stainless steels, while the tibial insert and patella trials are manufactured from medical grade polyphenylsulfone resin.

8. Substantial Equivalence Discussion

The Initia Knee System Indications for Use are identical to the predicate device's. The technological characteristics are the same or similar to those of the predicate device.

The same:

Materials: Co-Cr-Mo (Femoral); Ti-6Al-4V (Baseplate); Highly cross-linked UHMWPE with and without vitamin E, UHMWPE GUR1020 (Inserts and Patellae)
Cruciate-retaining and Posterior-stabilized designs

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Patellar locking mechanism
Cemented fixation only
Side-specific femoral configurations
. Sterilization: Gamma irradiation and Ethylene oxide
Performance: Baseplate fatigue; Tibial Post static fracture and fatigue; Tibial baseplate locking mechanism; Femoral/Tibial constraint; Femoral/Tibial contact area / stress; Patello/Femoral contact area / stress and subluxation; Femoral fatigue (Initia Knee only)

Similar:

Sizes:
- Initia Knee has 11 femoral sizes compared to 9 for the A200 Knee predicate, and is not о offered in a narrow size.
- Initia Knee has 10 baseplate sizes compared to 9 for the A200 Knee predicate, and is not O designed with separate left/right configurations.
- O Initia Knee has 7 tibial insert sizes compared to 3 for the A200 Knee predicate, and does not include a PS+ insert.
- Initia Knee has 7 patella sizes compared to 5 for the A200 Knee predicate, and has domed 3- O leg patella design only, whereas the predicate includes domed 3-leg and sombero designs.
Dimensions: Initia Knee components have slightly different dimensions than the predicate's, but results of testing raise no new questions of safety and effectiveness.

Based on verification and validation test results, the minor design differences between the subject device and predicate device do not raise new questions of safety or effectiveness as compared to the predicate device.

Non-Clinical Performance Data 9.

The following tests, also performed on the A200 Knee System predicate, were performed for the Initia Knee System components and found to be acceptable:

Tibial Post Fatigue Strength (static and fatigue)
Tibial Tray Locking Mechanism
Tibial-Femoral Constraint
Tibial-Femoral Contact Area/Contact Stress
Femoral Fatigue
Patello-Femoral Lateral Subluxation and Contact Area/Contact Stress

10. Consensus Standards

The Initia Knee System complies with the following standards:

. ASTM F1672-14 Standard Specification for Resurfacing Patellar Prosthesis
ASTM F1814-22 Standard Guide for Evaluating Modular Hip and Knee Joint Components
ASTM F2083-21 Standard Specification for Knee Replacement Prothesis
ASTM F3210-22 Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
. ASTM F1800-12 Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements

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. ISO 7207-2/2011/Amd 2:2020) Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials [Including AMENDMENT 1 (2016) and AMENDMENT 2 (2020)]
. ASTM F2003-02 (2022) Standard Practice for Accelerated Aging of Sterile Barrier Systems for Medical Devices
. ANSI/AAMI ST72:2019 Bacterial Endotoxins - Test Methods, Routine Monitoring, And Alternatives To Batch Testing
. AAMI/ANSI/ISO 11737-1:2018 Sterilization of health care products - microbiological methods - part 1: determination of the population of microorganisms on product
. AAMI/ANSI/ISO 10993-7:2008 (R)2012 Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals
. ANSI/AAMI/ISO 11135:2014 Sterilization of health care products – Ethylene oxide – Requirements for development, validation, and routine control of a sterilization process for medical devices
ISO 11607-1:2019 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems
. ISO 11607-2:2019 Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming sealing and assembly processes
ASTM F88/F88M-23 Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
. ASTM F2096-11(2019) Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
. ISO 11137-1(2006) Sterilization of health care products - Radiation - Part 1: Requirements for development validation and routine control of a sterilization process for medical devices
. ISO 11137-2(2013) Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
. ISO 11137-3(2017) Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development validation and routine control
ISO 11137-4(2020) Sterilization of health care products - Radiation - Part 4: Guidance on process control
ISO 10993-1:2018 Biological evaluation of medical devices
ISTA 2A (2011) Packaged-Products 150 lb (68 kg) or Less - Partial Simulation Performance Tests
ISTA 3A (2018) Packaged-Products for Parcel Delivery System Shipment 150 lb (68 kg) or Less
. ISO 15223-1 (2021) Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements
ASTM D4169-23e1 Standard Practice for Performance Testing of Shipping Containers and Systems
AAMI TIR28: 2016 (R2020) Product Adoption and Process Equivalency for Ethylene Oxide Sterilization
USP <85> Bacterial Endotoxins Test

11. Conclusion of Substantial Equivalence

The KMTI Initia Knee System has the same intended use as the legally marketed KMTI A200 Knee System predicate device and the same or similar technological characteristics. It has been demonstrated that differences are minor and do not raise different questions of safety and effectiveness than were raised by the predicate device. The data demonstrates that the Initia Knee System is substantially equivalent to the A200 Knee System predicate device.

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.