(269 days)
Not Found
No
The summary describes a knee replacement system made of specific materials and with geometric changes, with performance studies focused on material properties and mechanical characteristics. There is no mention of AI or ML.
Yes
The device is an orthopedic implant for total knee replacement, indicated for treating medical conditions like osteoarthritis and rheumatoid arthritis, which are therapeutic uses.
No
This device is a knee replacement implant, which is a therapeutic device, not a diagnostic one. Its purpose is to replace damaged knee components, not to diagnose medical conditions.
No
The device description clearly states that the TRULIANT Knee System is a system of orthopedic implants, including physical components like Femoral components, Tibial Trays, Tibial Inserts, and Patellas, made from materials like UHMWPE. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for total knee replacement surgery in skeletally mature individuals due to various degenerative conditions and for revision surgeries. This is a surgical implant, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as orthopedic implants (Tibial Inserts and Patellas) made from UHMWPE. These are physical components implanted into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's health status.
The device is clearly an orthopedic implant used in a surgical procedure.
N/A
Intended Use / Indications for Use
The TRULIANT E-PX Tibial Inserts and Patellas are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revious reconstructions where sufficient bone stock and soft tissue integrity are present.
The TRULIANT E-PX Patellas are intended for cemented use only.
Product codes
JWH
Device Description
The TRULIANT Knee System is a system of orthopedic implants intended for total knee replacement. The system includes Femoral components, Tibial Trays, Tibial Inserts, and Patellas. The Tibial Inserts and Patellas used in the TRULIANT Knee system currently are constructed of compression molded UHMWPE and extruded UHMWPE respectively. This submission proposes TRULIANT Tibial Inserts and Patellas made from UHMWPE containing vitamin E. This submission additionally proposes minor geometric change(s) to all Tibial Insert devices as well as additional intermediate TRULIANT CC Tibial Insert size options.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
skeletally mature individuals
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
The following non-clinical testing and engineering analyses were performed to demonstrate that the Exactech TRULIANT Tibial Inserts and Patellas perform as intended and are substantially equivalent to the identified predicate devices:
- Material Characterization
- Wear
- Fatigue
- Range of Motion
- Tibial-femoral stability characteristics
- Tibial modular disassembly characteristics
- Biocompatibility
- Bacterial endotoxins
The differences in raw material and geometry do not change the intended use, safety, or performance requirements of the proposed devices, nor do they adversely affect their safety or effectiveness. This conclusion is based on consideration of the preclinical testing and analysis including material characterization, biocompatibility assessment and testing and mechanical testing and analysis completed to establish substantial equivalence of the proposed devices to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K152170, K171045, K932690, K160484, K150890, K211877
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
July 17, 2023
Elizabeth Howell Senior Regulatory Specialist 2320 NW 66th Ct Gainesville, Florida 32653
Re: K223252
Trade/Device Name: TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: June 13, 2023 Received: June 13, 2023
Dear Elizabeth Howell:
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 (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 located 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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.
Lixin Liu -S
Lixin Liu, Ph.D. 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) K223252
Device Name TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas
Indications for Use (Describe)
The TRULIANT E-PX Tibial Inserts and Patellas are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteonecrosis, theumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revious reconstructions where sufficient bone stock and soft tissue integrity are present.
The TRULIANT E-PX Patellas are 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
TRULIANT® E-PX Tibial Inserts and Patellas 510(k) Summary
| Applicant: | Exactech®, Inc.
2320 NW 66th Court
Gainesville FL, 32653 |
|----------------------|------------------------------------------------------------------------------------------------------|
| | Phone: (352) 377-1140
Fax: (352) 378-2617 |
| Applicant Contact: | Elizabeth Howell
Senior Regulatory Specialist
Telephone: (352) 377-1140
Fax: (352) 378-2617 |
| Date: | July 14, 2023 |
| Device Trade Name: | TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX
Patellas |
| Common Name: | Total Knee Prosthesis |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer
semi-constrained cemented prosthesis |
| Regulation Number: | 888.3560 |
| Product Code: | JWH |
Legally Marketed Predicate Devices:
| Predicate | Predicate Trade Name (Primary Predicate is listed | Product |
|---|---|---|
| Number | first) | Code |
| K152170 | Exactech Optetrak Logic Enhanced Assembly | JWH |
| K171045 | Exactech Truliant Line Extensions | JWH |
| K932690 | Exactech Cruciate Retaining Cemented Total Knee System | JWH |
| K160484 | Optetrak Advanced Patella | JWH |
| K150890 | Exactech Optetrak Logic CC | JWH |
| K211877 | Klassic Knee System | JWH |
Device Description Summary
The TRULIANT Knee System is a system of orthopedic implants intended for total knee replacement. The system includes Femoral components, Tibial Trays, Tibial Inserts, and Patellas. The Tibial Inserts and Patellas used in the TRULIANT Knee system currently are constructed of compression molded UHMWPE and extruded UHMWPE respectively. This submission proposes TRULIANT Tibial Inserts and Patellas made from UHMWPE containing vitamin E. This submission additionally proposes minor geometric change(s) to all Tibial Insert devices as well as additional intermediate TRULIANT CC Tibial Insert size options.
4
TRULIANT® E-PX Tibial Inserts and Patellas 510(k) Summarv
Intended Use/Indications for Use
The TRULIANT E-PX Tibial Inserts and Patellas are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
The TRULIANT E-PX Patellas are intended for cemented use only.
Indications for Use Comparison
The subject and the predicate devices have the same indications for use.
Technological Comparison
The proposed and predicate devices have the same intended use and similar basic fundamental scientific technology. The rationale for substantial equivalence of the proposed to the predicate cleared devices is based on consideration of the following aspects of the devices:
- . The subject and the predicate devices are composed of the similar biocompatible materials.
- The subject and the predicate devices have similar design features.
- . The proposed and predicate devices are provided sterile for single use only.
- The proposed and predicate devices conform to recognized performance . standards for knee replacement devices.
Non-Clinical and/or Clinical Tests Summary & Conclusions
The following non-clinical testing and engineering analyses were performed to demonstrate that the Exactech TRULIANT Tibial Inserts and Patellas perform as intended and are substantially equivalent to the identified predicate devices:
- . Material Characterization
- Wear ●
- Fatigue ●
- Range of Motion ●
- Tibial-femoral stability characteristics ●
- Tibial modular disassembly characteristics ●
- Biocompatibility ●
- Bacterial endotoxins
The differences in raw material and geometry do not change the intended use, safety, or performance requirements of the proposed devices, nor do they adversely affect their safety or effectiveness. This conclusion is based on consideration of the preclinical testing and analysis including material characterization, biocompatibility assessment and testing and mechanical testing and analysis completed to establish substantial equivalence of the proposed devices to the predicate devices.