(28 days)
No
The document describes a mechanical implant (femoral components for knee replacement) and its modifications, with no mention of AI or ML technology in its function, design, or testing.
Yes.
The device is indicated for use in primary surgery for total knee replacement due to various medical conditions and for revision of failed previous reconstructions, which are therapeutic interventions.
No
The device description clearly states that these are components for total knee replacement surgery (implants), not tools for diagnosis. Its purpose is to replace bone, not to identify or monitor medical conditions.
No
The device description clearly states the device is a physical implant made of CoCr alloy, designed for surgical implantation as part of a total knee replacement. It is a hardware device, not software.
Based on the provided text, 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. This is a surgical procedure involving the implantation of a medical device into the body.
- Device Description: The device is described as femoral components, tibial inserts, and tibial trays made from materials like CoCr alloy and ultra-high molecular weight polyethylene. These are physical implants designed to replace parts of the knee joint.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. The provided text does not mention any testing of biological samples or diagnostic purposes.
The device described is a surgical implant used for treatment, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
The TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays 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 Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only.
Product codes
JWH
Device Description
Truliant femoral components are for use in resurfacing femoral bone as part of tricompartmental total knee arthroplasty employing modular components from the Optetrak / Optetrak Logic and Truliant device families.
Truliant femoral components represent modifications to Exactech One Logic femoral components cleared per 510(k) K153776. The proposed Truliant femoral components are identical to predicated One Logic femoral components, with the following key exceptions:
- . Tapered anterior chamfer and patella flange to reduce the appearance of implant / bone overhang
- . Patella flange cement pocket has been modified to increase cement / bone contact area
Additional modifications have been made to facilitate manufacturing.
Like other femoral implants in compatible device families, One Logic femoral components are made from CoCr alloy and are designed to articulate on an ultra-high molecular weight polyethylene tibial insert seated in a metal tibial tray.
Truliant femoral components have the same basic features and articulating surface finish as predicate One Logic femoral components while providing surgeons with an option for a femoral implant with a patella flange that has been comparatively streamlined in the medial-lateral aspects. The articulating congruence featured in all Optetrak and Optetrak Logic femoral-tibial condyle contact is maintained for Truliant femoral components. Cruciate-retaining Truliant femoral components also feature the same patella entry / exit point at the distal trochlear groove featured on predicate One Logic femoral components and intended to enhance patella transition.
The proposed devices operate using same fundamental scientific technology, have the same intended use and design features, employ the same materials of construction, are offered in the same product size scopes, and are implanted using a similar surgical technique and the same or similar instrumentation. The only modifications proposed by this submission are dimensional.
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)
This submission includes results for mechanical patellofemoral constraint and contact pressure testing. Results conclude the proposed Truliant devices do not represent a new worst-case for risks associated with patellofemoral contact.
Pyrogen testing was conducted in accordance with USP , USP , and ANSI/AAMI ST72 to ensure the proposed Truliant components meet recommended limits per FDA's Guidance Document Submission and Review of Sterility Information in Premarket (510(k)) Submission for Devices Labeled as Sterile.
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
§ 888.3560 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.
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 23, 2017
Exactech Inc Patrick Hughes Senior Regulatory Affairs Specialist 2320 N.W. 66th Ct Gainesville, Florida 32653
Re: K170240
Trade/Device Name: Truliant Femoral Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: January 24, 2017 Received: January 26, 2017
Dear Mr. Hughes:
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. 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.
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170240
Device Name Truliant Femoral Components
Indications for Use (Describe)
The TRULIANT Femoral Components, Tibial Trays 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 Femoral Components, Tibial Inserts, and Tibial Trays are indicated 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
Exactech® Truliant™ Femoral Components Special 510(k) - 510(k) Summary of Safety and Effectiveness
| Sponsor: | Exactech, Inc.
2320 N.W. 66th Court
Gainesville, FL 32653 |
|----------|-----------------------------------------------------------------|
| | Phone: (352) 377-1140 |
| | Fax: (352) 378-2617 |
FDA Establishment Number 1038671
Patrick Hughes Contact: Senior Regulatory Affairs Specialist
- Date: January 24, 2017
Trade or Proprietary or Model Name(s):
Exactech® Truliant™ Femoral Components
Common Name: Cemented Total Knee Prosthesis
Classification Name:
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Product Code: JWH
Classification Panel: Orthopedic
Regulation Number 888.3560
Device Class II
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or Proprietary Model Name | Manufacturer |
|---|---|---|
| K153776 | Exactech One Logic Femoral Components | Exactech, Inc |
Indications for Use:
The TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-
4
Exactech® Truliant™ Femoral Components Special 510(k) - 510(k) Summary of Safety and Effectiveness
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 Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only.
Device Description:
Truliant femoral components are for use in resurfacing femoral bone as part of tricompartmental total knee arthroplasty employing modular components from the Optetrak / Optetrak Logic and Truliant device families.
Truliant femoral components represent modifications to Exactech One Logic femoral components cleared per 510(k) K153776. The proposed Truliant femoral components are identical to predicated One Logic femoral components, with the following key exceptions:
- . Tapered anterior chamfer and patella flange to reduce the appearance of implant / bone overhang
- . Patella flange cement pocket has been modified to increase cement / bone contact area
Additional modifications have been made to facilitate manufacturing.
Like other femoral implants in compatible device families, One Logic femoral components are made from CoCr alloy and are designed to articulate on an ultra-high molecular weight polyethylene tibial insert seated in a metal tibial tray.
Truliant femoral components have the same basic features and articulating surface finish as predicate One Logic femoral components while providing surgeons with an option for a femoral implant with a patella flange that has been comparatively streamlined in the medial-lateral aspects. The articulating congruence featured in all Optetrak and Optetrak Logic femoral-tibial condyle contact is maintained for Truliant femoral components. Cruciate-retaining Truliant femoral components also feature the same patella entry / exit point at the distal trochlear groove featured on predicate One Logic femoral components and intended to enhance patella transition.
The proposed devices operate using same fundamental scientific technology, have the same intended use and design features, employ the same materials of construction, are offered in the same product size scopes, and are implanted using a similar surgical technique and the same or similar instrumentation. The only modifications proposed by this submission are dimensional.
5
Exactech® Truliant™ Femoral Components Special 510(k) - 510(k) Summary of Safety and Effectiveness
Testing Description:
This submission includes results for mechanical patellofemoral constraint and contact pressure testing. Results conclude the proposed Truliant devices do not represent a new worst-case for risks associated with patellofemoral contact.
Pyrogen testing was conducted in accordance with USP , USP , and ANSI/AAMI ST72 to ensure the proposed Truliant components meet recommended limits per FDA's Guidance Document Submission and Review of Sterility Information in Premarket (510(k)) Submission for Devices Labeled as Sterile.
Substantial Equivalence Conclusion:
Results of engineering studies referenced in this 510(k) submission demonstrate proposed Truliant devices are substantially equivalent to cited cleared predicate One Logic devices.