(238 days)
Not Found
No
The summary describes a mechanical implant (knee replacement system) and the testing performed on it. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes
The device explicitly states its intended use is for "total knee replacement" to address various medical conditions, including "osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems," and for "revision of failed previous reconstructions." These indications clearly define it as a device used to treat or alleviate a medical condition, which is the definition of a therapeutic device.
No
The device is a knee replacement system, which is a prosthetic implant used in surgery, not a device designed to identify or determine the nature of a disease or condition.
No
The device description clearly states it is a total knee replacement system comprised of physical implants (femoral, tibial, and patellar). The performance studies also focus on physical properties and testing of these implants. There is no mention of software as the primary or sole component.
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 description clearly states that the Exactech® TRULIANT® Knee System is a total knee replacement system comprised of implants (femoral, tibial, and patellar). These are surgically implanted devices, not devices used for testing samples outside the body.
- Intended Use: The intended use is for total knee replacement surgery due to various degenerative problems and for revision of failed previous reconstructions. This is a surgical procedure, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on bodily fluids, or providing diagnostic information based on laboratory analysis.
Therefore, the Exactech® TRULIANT® Knee System is a surgical implant device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Exactech® TRULIANT® Knee System is 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. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
The TRULIANT Cemented Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only. The TRULIANT Porous Femoral Components are indicated for cemented or cementless use. The TRULIANT Porous Tibial Trays are indicated for cemented or cementless use.
Product codes
MBH, JWH
Device Description
The Exactech® Truliant® Knee System is a total knee replacement system comprised of femoral, tibial, and patellar implants. The proposed Porous Tibias are additional tibial tray implant variants intended for use with the Truliant Knee System. This submission proposes Truliant Porous Tibial Trays made from titanium alloy consolidated via direct metal laser sintering (DMLS). This submission additionally proposes a Porous Tibial Tray variant without screw holes, additional intermediate tray sizes, and minor geometric change(s) to the predicate Porous Tibial Tray design.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical testing and engineering analyses were performed to demonstrate that the Truliant Porous Tibial Trays perform as intended and are substantially equivalent to the identified predicate devices:
- Screw pull through testing ●
- Fatigue Testing per ASTM F1800-19e1 ●
- Porous Structure Characterization per ASTM F1854-15, ASTM F1160-. 14(2017)e1, ISO 13179-1:2021(E), ASTM F1044-05(2017)e1, ASTM F1147-05(2017)e1, ASTM F1978-18, ISO 13314:2011
- Biocompatibility per ISO 10993-1:2018 ●
- Bacterial endotoxins per USP , USP and ANSI/AAMI ST72
The differences in raw material, processing, porous structure, and device 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 fatigue, mechanical, material characterization, porous structure characterization, biocompatibility assessment and testing completed to establish substantial equivalence of the proposed devices to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
0
Image /page/0/Picture/0 description: The image shows 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.
October 3, 2024
Exactech Inc. Liz Howell Senior Regulatory Specialist 2320 NW 66th Court Gainesville, Florida 32653
Re: K240393
Trade/Device Name: Exactech® TRULIANT® Knee System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: February 8, 2024 Received: September 3, 2024
Dear Liz 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 (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.
1
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 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-regulatory
2
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,
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
3
Indications for Use
510(k) Number (if known) K240393
Device Name Exactech® TRULIANT® Knee System
Indications for Use (Describe)
The Exactech® TRULIANT® Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, theumatoid arthritis and or post-traumatic degenerative problems. It is also indicated for revious reconstructions where sufficient bone stock and soft tissue integrity are present.
The TRULIANT Cemented Femoral Components, Tibial Trays are indicated for cemented use only. The TRULIANT Porous Femoral Components are indicated for cementless use. The TRULIANT Porous Tibial Trays are indicated for cemented or cementless use.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Exactech® TRULIANT® Knee System 510(k) Summary
| Applicant: | Exactech , Inc.
2320 NW 66th Court
Gainesville FL, 32653
Phone: (352) 377-1140
Fax: (352) 378-2617 |
|----------------------|---------------------------------------------------------------------------------------------------------------------|
| Applicant Contact: | Liz Howell
Principal Regulatory Specialist
Telephone: (352) 377-1140
Fax: (352) 378-2617 |
| Date: | October 2, 2024 |
| Device Trade Name: | Exactech® TRULIANT® Knee System |
| Common Name: | Total Knee Replacement system |
| Classification Name: | Knee joint patellofemorotibial metal/polymer porous-
coated uncemented prosthesis |
| Regulation Number: | 888.3565 |
| Product Code: | MBH, JWH |
Legally Marketed Predicate Devices:
| Predicate
Number | Predicate Trade Name (Primary Predicate is listed first) | Product
Code |
|---------------------|----------------------------------------------------------|-----------------|
| K182346 | Truliant Porous Tibial Trays | MBH |
Device Description Summary
The Exactech® Truliant® Knee System is a total knee replacement system comprised of femoral, tibial, and patellar implants. The proposed Porous Tibias are additional tibial tray implant variants intended for use with the Truliant Knee System. This submission proposes Truliant Porous Tibial Trays made from titanium alloy consolidated via direct metal laser sintering (DMLS). This submission additionally proposes a Porous Tibial Tray variant without screw holes, additional intermediate tray sizes, and minor geometric change(s) to the predicate Porous Tibial Tray design.
5
Exactech® TRULIANT® Knee System 510(k) Summary
Intended Use/Indications for Use
The Exactech® TRULIANT® Knee System is 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. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
The TRULIANT Cemented Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only. The TRULIANT Porous Femoral Components are indicated for cemented or cementless use. The TRULIANT Porous Tibial Trays are indicated for cemented or cementless use.
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 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 proposed and predicate devices are composed of similar biocompatible materials.
- The proposed and predicate devices have the same or 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 Truliant Porous Tibial Trays perform as intended and are substantially equivalent to the identified predicate devices:
- Screw pull through testing ●
- Fatigue Testing per ASTM F1800-19e1 ●
- Porous Structure Characterization per ASTM F1854-15, ASTM F1160-. 14(2017)e1, ISO 13179-1:2021(E), ASTM F1044-05(2017)e1, ASTM F1147-05(2017)e1, ASTM F1978-18, ISO 13314:2011
- Biocompatibility per ISO 10993-1:2018 ●
- Bacterial endotoxins per USP , USP and ANSI/AAMI ST72
The differences in raw material, processing, porous structure, and device 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
6
Exactech® TRULIANT® Knee System 510(k) Summary
conclusion is based on consideration of the preclinical testing and analysis including fatigue, mechanical, material characterization, porous structure characterization, biocompatibility assessment and testing completed to establish substantial equivalence of the proposed devices to the predicate devices.