(21 days)
Not Found
No
The summary describes modifications to existing knee replacement components (femoral components, tibial inserts, and tibial trays) that are purely dimensional. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies focus on mechanical properties and biocompatibility, not algorithmic performance.
Yes.
The device is indicated for use in surgical procedures to replace a total knee, treating conditions such as osteoarthritis and rheumatoid arthritis, which are therapeutic interventions.
No
Explanation: The provided text describes the TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays as devices for total knee replacement surgery. Their intended use is to replace failed previous reconstructions or to be used in primary surgery for conditions like osteoarthritis. This is a therapeutic or reconstructive function, not a diagnostic one.
No
The device description clearly states the device consists of physical components (Femoral Components, Tibial Inserts, and Tibial Trays) used in total knee replacement surgery. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes implants (femoral components, tibial inserts, and tibial trays) used in total knee replacement surgery. These are physical devices surgically placed within the body.
- Intended Use: The intended use is for "primary surgery for total knee replacement" and "revision of failed previous reconstructions." This is a surgical procedure, not a diagnostic test performed on a specimen outside the body.
The device is a surgical implant used to replace parts of the knee joint.
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 revious 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 (comma separated list FDA assigned to the subject device)
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.
Proposed Truliant femoral components represent modifications to Truliant femoral components cleared per 510(k) K170240. The proposed Truliant femoral components are identical to cited predicate femoral components except for dimensional modifications representing new additions to the product scope.
Proposed Truliant tibial trays represent modifications to One Logic tibial trays cleared per 510(k) K152170 and rebranded as Truliant per 510(k) K170240. The proposed Truliant trays are identical to cited predicate trays except for dimensional modifications representing new additions to the product scope.
Proposed Truliant tibial inserts represent modifications to One Logic tibial inserts cleared per 510(k) K152170 and rebranded as Truliant per 510(k) K170240. The proposed Truliant inserts are identical to cited predicate inserts except for dimensional modifications representing new additions to the product scope.
The proposed devices operate using the 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 references results for mechanical patellofemoral constraint, patellofemoral contact pressure testing, mechanical insert / tray assembly micromotion, mechanical insert / tray locking strength, and device biocompatibility. Results conclude the proposed Truliant devices do not represent a new worst-case for risks associated with patellofemoral contact, insert / tray assembly properties, or biocompatibility.
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): 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.
Not Found
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
§ 888.3560 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
Public Health Service
Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 28, 2017
Exactech. Inc. Patrick Hughes Senior Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653
Re: K171045
Trade/Device Name: Exactech® Truliant™ Line Extensions 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: April 6, 2017 Received: April 7, 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.
Vincent J. Devlin -S
for
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) K171045
Device Name Exactech® Truliant™ Line Extensions
Indications for Use (Describe)
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 revious 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™ Line Extensions 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 |
| Contact: | Patrick Hughes
Senior Regulatory Affairs Specialist |
Date: April 6, 2017
Trade or Proprietary or Model Name(s): Exactech® Truliant™ Line Extensions
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 |
|---|---|---|
| K170240 | Exactech Truliant Femoral Components | Exactech, Inc |
| K152170 | Exactech One Logic Tibial Assembly | 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™ Line Extensions 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.
Proposed Truliant femoral components represent modifications to Truliant femoral components cleared per 510(k) K170240. The proposed Truliant femoral components are identical to cited predicate femoral components except for dimensional modifications representing new additions to the product scope.
Proposed Truliant tibial trays represent modifications to One Logic tibial trays cleared per 510(k) K152170 and rebranded as Truliant per 510(k) K170240. The proposed Truliant trays are identical to cited predicate trays except for dimensional modifications representing new additions to the product scope.
Proposed Truliant tibial inserts represent modifications to One Logic tibial inserts cleared per 510(k) K152170 and rebranded as Truliant per 510(k) K170240. The proposed Truliant inserts are identical to cited predicate inserts except for dimensional modifications representing new additions to the product scope.
The proposed devices operate using the 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™ Line Extensions Special 510(k) - 510(k) Summary of Safety and Effectiveness
Testing Description:
This submission references results for mechanical patellofemoral constraint, patellofemoral contact pressure testing, mechanical insert / tray assembly micromotion, mechanical insert / tray locking strength, and device biocompatibility. Results conclude the proposed Truliant devices do not represent a new worst-case for risks associated with patellofemoral contact, insert / tray assembly properties, or biocompatibility.
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 line extensions are substantially equivalent to cited cleared predicate Truliant femoral components and One Logic / Truliant tibial inserts and tibial trays.