(90 days)
No
The document describes a knee and hip implant system and bone screws, focusing on materials, manufacturing processes (EBM), and mechanical testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device, comprising femoral components, tibial inserts, tibial trays, and bone screws, is indicated for therapeutic purposes such as total knee and hip replacement due to various medical conditions like osteoarthritis, rheumatoid arthritis, osteonecrosis, and post-traumatic degenerative problems, as well as for revision surgeries. These applications clearly fall under the definition of a therapeutic device as they treat or alleviate a disease or condition.
No
Explanation: The device is a knee and hip implant, specifically femoral components, tibial inserts, tibial trays, and bone screws, used for total joint replacements. Its purpose is to replace failed joints or treat fractures, not to diagnose medical conditions.
No
The device description explicitly states it is a tibial tray implant manufactured from titanium alloy, which is a hardware component. The performance studies also focus on the mechanical properties of the physical implant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used in the body during surgical procedures for total knee and hip replacement. IVDs are used outside the body to examine specimens (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The device is described as an implant (femoral components, tibial inserts, tibial trays, bone screws) made from titanium alloy. This is consistent with surgical implants, not diagnostic devices.
- Performance Studies: The performance studies focus on the mechanical strength and fatigue properties of the implant, which are relevant to its function within the body. IVD performance studies would focus on analytical and clinical performance related to detecting specific substances or conditions in specimens.
The device is a surgical implant used for orthopedic procedures, not a diagnostic tool used to test biological samples.
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 posttraumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
All TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only, except the TRULIANT Porous Tibial Trays, which are indicated for cemented or cementless use.
Exactech Alteon Bone Screws are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Exactech Alteon Bone Screws are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
The Exactech Alteon Bone Screws are also 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.
Product codes (comma separated list FDA assigned to the subject device)
MBH, JWH
Device Description
The tibial tray implant and its porous structure is manufactured from Ti-6Al-4V titanium alloy using electron beam melting (EBM) technology. This product line represents a scope extension of the Truliant knee implant system. The previously cleared Alteon Bone Screws are now cleared for use with the TRULIANT Porous Tibial Trays.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, Hip
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 TRULIANT Porous Tibial Tray has been tested in the following test modes:
- Tibial tray fatigue per ASTM F1800-12
- Shear fatigue of an EBM porous structure per ASTM F1160-14 (2017)
- Static shear of an EBM porous structure per ASTM F1044-05 (2017)
- Static tension of an EBM porous structure per ASTM F1147-95 (2017)
- Static compression of an EBM porous structure per ASTM E9-09 (2018)
- Porous coating characterization per ASTM F1854-15
The results of this non-clinical testing show that the strength of the TRULIANT Porous Tibial Tray is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. Pyrogenicity testing was also conducted and demonstrates that the endotoxin limit is less than 20 EU/device.
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.
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). 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.
November 26, 2018
Exactech, Inc. % Meredith May Vice President Empirical Consulting LLC 4628 Northpark Dr. Colorado Springs, Colorado 80918
Re: K182346
Trade/Device Name: TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Codes: MBH, JWH Dated: August 24, 2018 Received: August 28, 2018
Dear Meredith May:
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/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,
Daniel S. Ramsey -S 2018.11.26 11:34:06 -05'00'
FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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 on last page.
510(k) Number (if known) K182346 Device Name
TRULIANT Porous Tibial Trav
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 posttraumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
All TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only, except the TRULIANT Porous Tibial Trays, which 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Druq Administration
Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. "
3
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 on last page.
| 510(k) Number (if known) |
|---|
| K182346 |
| Device Name |
| Exactech® Alteon® Bone Screws |
Indications for Use (Describe)
Exactech Alteon Bone Screws are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Exactech Alteon Bone Screws are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
The Exactech Alteon Bone Screws are also indicated for use in skeletally mature individuals undergoing primary surgerv 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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including
the time to review instructions, search existing data sources, gather and maintain the data needed and
complete and review the collection of information. Send comments regarding this burden estimate or any
other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information
unless it displays a currently valid OMB number."
4
510(K) SUMMARY
| Submitter's Name: | Exactech, Inc. |
|---|---|
| Submitter's Address: | 2320 N.W. 66th Court |
| Gainesville, Florida 32653 | |
| Submitter's Telephone: | (352) 378-2617 |
| Contact Person: | Meredith Lee May MS, RAC |
| Empirical Consulting | |
| 719.337.7579 | |
| MMay@EmpiricalConsulting.com | |
| Date Summary was Prepared: | 24-Aug-18 |
| Trade or Proprietary Name: | TRULIANT Porous Tibial Tray |
| Alteon Bone Screws | |
| Common or Usual Name: | Prosthesis, Knee, Patello/Femorotibial, Semi- |
| Constrained, Uncemented, Porous, Coated, Polymer/ | |
| Metal/Polymer |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained,
Cemented, Polymer/Metal/Polymer |
| Classification: | Class II per 21 CFR §888.3565 and 21 CFR §888.3560 |
| Product Code: | MBH, JWH |
| Classification Panel: | Orthopedic |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The tibial tray implant and its porous structure is manufactured from Ti-6Al-4V titanium alloy using electron beam melting (EBM) technology. This product line represents a scope extension of the Truliant knee implant system. The previously cleared Alteon Bone Screws are now cleared for use with the TRULIANT Porous Tibial Trays.
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, theumatoid 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.
5
All TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only, except the TRULIANT Porous Tibial Trays, which are indicated for cemented or cementless use.
Exactech Alteon Bone Screws are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Exactech Alteon Bone Screws are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
The Exactech Alteon Bone Screws are also 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.
TECHNOLOGICAL CHARACTERISTICS
TRULIANT Porous Tibial Tray and Alteon Bone Screws are made from Ti-6Al-4V that conforms to ASTM F2924-14 or ASTM F136-13. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:
- Indications for Use o
- Materials of manufacture ●
- Method of manufacture ●
- Mechanical strength .
| 510k Number | Trade or Proprietary or
Model Name | Manufacturer | Predicate
Type |
|-------------|-------------------------------------------------------|------------------------------------------------------|-------------------|
| K123486 | Triathlon Tritanium Tibial
Baseplates | Howmedica Osteonics
Corp (marketed by
Stryker) | Primary |
| K120990 | NexGen® LCCK Trabecular
Metal Coupled Tibial Cones | Zimmer Trabecular
Metal Technology, Inc. | Additional |
| K153595 | Optetrak Logic Metaphyseal
Cones | Exactech, Inc. | Additional |
| K141797 | Alteon 6.5mm Bone Screws | Exactech, Inc. | Additional |
Table 5-1 Predicate Devices
6
PERFORMANCE DATA
The TRULIANT Porous Tibial Tray has been tested in the following test modes:
- Tibial tray fatigue per ASTM F1800-12 o
- Shear fatigue of an EBM porous structure per ASTM F1160-14 (2017) ●
- Static shear of an EBM porous structure per ASTM F1044-05 (2017) ●
- Static tension of an EBM porous structure per ASTM F1147-95 (2017) o
- Static compression of an EBM porous structure per ASTM E9-09 (2018) .
- Porous coating characterization per ASTM F1854-15 o
The results of this non-clinical testing show that the strength of the TRULIANT Porous Tibial Tray is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. Pyrogenicity testing was also conducted and demonstrates that the endotoxin limit is less than 20 EU/device.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the TRULIANT Porous Tibial Tray and Alteon Bone Screws are substantially equivalent to the predicate device.