(265 days)
No
The summary describes a mechanical knee replacement system and its materials and testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a knee replacement prosthesis for patients with painful and disabled knee joints, indicating its therapeutic purpose to alleviate pain and restore function.
No
The device is a partial knee replacement prosthesis, used for treatment rather than diagnosis.
No
The device description clearly states it is a partial knee replacement prosthesis made of physical materials (CoCrMo Alloy, Ti6Al4V Alloy, UHMWPE) and includes performance studies related to the mechanical properties of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The Kyocera TRIBRID® Unicompartmental Knee System is a partial knee replacement prosthesis. It is an implantable device used to replace damaged parts of the knee joint.
- Intended Use: The intended use is to treat painful and disabled knee joints resulting from conditions like osteoarthritis or osteonecrosis, and to correct deformities. This involves surgical implantation, not laboratory testing of samples.
The description clearly indicates a surgical implant, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HSX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee Joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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).
1
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
2
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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3
K232114 - 510(K) SUMMARY
| Submitter's Name: | Kyocera Medical Technologies, Inc. |
|---|---|
| Submitter's Address: | 1200 California Street |
| Suite 210 | |
| Redlands, California 92374 | |
| Submitter's Telephone: | (979) 492-6848 |
| Contact Person: | Nathan Wright MS, RAC |
| Empirical Technologies | |
| 1-719-351-0248 | |
| nwright@empiricaltech.com | |
| Image: 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:
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.
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 ●
4
Predicate Devices
| 510k Number | Trade or Proprietary or
Model Name | Manufacturer | Product
Code | Type |
|-------------|---------------------------------------|------------------------------------------------------|-----------------|------------------|
| K190085 | JOUNEY II
Unicompartmental Knee | Smith & Nephew, Inc. | HSX | Predicate |
| K183029 | MOTO™ Lateral Partial
Knee System | Medacta International SA | HSX | Reference Device |
| K190122 | Renovis A200 PS Knee
System | Revnovis (now Kyocera
Medical 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.