(85 days)
Not Found
No
The summary describes a mechanical orthopedic implant (femoral components for knee replacement) and its equivalence to a predicate device. There is no mention of software, algorithms, data analysis, or any terms related to AI/ML. The performance studies focus on mechanical properties and simulated use, not algorithmic performance.
No.
The device is a medical implant (femoral component for total knee replacement) and not directly involved in therapy delivery or monitoring.
No
Explanation: This device is a total knee replacement component, specifically femoral components, tibial inserts, and tibial trays. Its intended use is for surgical implantation in individuals undergoing primary or revision total knee replacement, not for diagnosing medical conditions.
No
The device description clearly states it is a physical component (femoral components, tibial inserts, and tibial trays) used in total knee replacement surgery, not software.
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. This is a surgical procedure involving the implantation of a medical device.
- Device Description: The device is described as femoral components, tibial inserts, and tibial trays used in total knee arthroplasty. These are physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
MBH, 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 porous femoral components represent modifications to Optetrak Logic porous femoral components cleared per 510(k) K140302. The proposed Truliant porous femoral components are identical to other Truliant femoral components but employ a porous structure identical to that used for the cited predicate femoral components and can be implanted as part of an uncemented surgical approach.
Proposed and predicate 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 similar product size scopes, are implanted using similar surgical techniques and the same or similar instrumentation, have equivalent Indications for Use statements, and, size for size, are compatible with the same Optetrak, Optetrak Logic, and Truliant patellar and tibial components.
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
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)
Results of engineering studies referenced in this 510(k) submission demonstrate proposed Truliant porous femoral components are substantially equivalent to cited cleared predicate Optetrak Logic porous femoral components.
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
§ 888.3565 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). 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
September 28, 2018
Exactech, Inc. Patrick Hughes Regulatory Affairs Manager 2320 NW 66th CT Gainesville, Florida 32653
Re: K181794
Trade/Device Name: Truliant Porous Femoral Components 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: September 5, 2018 Received: September 7, 2018
Dear Patrick 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 mav, 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 avare 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.
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
1
requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 2018.09.28 14:18:50 -04'00'
- Mark N. Melkerson FOR Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
| Indications for Use |
| Form Approved: OMB No. | 0910-0120 |
|---|---|
| Expiration Date: | 06/30/2020 |
| See PRA Statement below. |
| 510(k) Number (if known) | K181794 |
|---|---|
| Device Name | Truliant Porous Femoral Components |
| 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 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. |
| 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| FORM FDA 3881 (7/17) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF |
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Exactech® Truliant® Porous Femoral Components Special 510(k) - 510(k) Summary
| 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
Regulatory Affairs Manager |
July 2, 2018 Date:
Trade or Proprietary or Model Name(s):
Exactech® Truliant® Porous Femoral Components
Common Name:
Uncemented or Cemented Total Knee Prosthesis
Classification Name:
Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis
Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
Product Code: MBH, JWH
Classification Panel: Orthopedic
Regulation Number
888.3565 888.3560
Device Class II
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or Proprietary Model Name | Manufacturer |
|---|---|---|
| K140302 | Optetrak Logic Porous Femoral Components | Exactech, Inc |
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Exactech® Truliant® Porous Femoral Components Special 510(k) - 510(k) Summary
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 posttraumatic degenerative problems. They are 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.
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 porous femoral components represent modifications to Optetrak Logic porous femoral components cleared per 510(k) K140302. The proposed Truliant porous femoral components are identical to other Truliant femoral components but employ a porous structure identical to that used for the cited predicate femoral components and can be implanted as part of an uncemented surgical approach.
Proposed and predicate 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 similar product size scopes, are implanted using similar surgical techniques and the same or similar instrumentation, have equivalent Indications for Use statements, and, size for size, are compatible with the same Optetrak, Optetrak Logic, and Truliant patellar and tibial components.
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Exactech® Truliant® Porous Femoral Components Special 510(k) - 510(k) Summary
Testing Description:
This submission references results for:
- . Simulated use activities
- Surgeon expert evaluation
- . Engineering analysis of device press-fit.
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 porous femoral components are substantially equivalent to cited cleared predicate Optetrak Logic porous femoral components.