(70 days)
Not Found
Not Found
No
The 510(k) summary describes a total knee replacement system with mechanical components and does not mention any AI or ML technology. The performance studies focus on material properties, wear, and mechanical testing.
Yes
The device is a knee replacement system intended to treat painful, disabling joint disease and other knee conditions, which aligns with the definition of a therapeutic device.
No
Explanation: The provided text describes a total knee arthroplasty system, focusing on its components, indications for use in treating knee joint diseases, and performance studies related to material properties and mechanical testing. There is no mention of the device being used to identify or diagnose medical conditions.
No
The device description clearly states it includes "tibial and patellar components of a total knee system," which are physical implants, not software.
No, 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, tissue) to provide information about a person's health.
- Device Description: The provided text describes components of a total knee replacement system (tibial inserts and patellar components). These are implantable devices used to replace damaged parts of the knee joint.
- Intended Use: The intended use is to treat painful and disabling joint disease of the knee by replacing the articulating surfaces. This is a surgical procedure, not a diagnostic test performed on a sample.
The device is a surgical implant used in total knee arthroplasty, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Triathlon® X3™ UHMWPE Posterior Stabilized and Cruciate Retaining tibial inserts and the Triathlon® X3™ UHMWPE Patellar components are intended to be used with the cemented Triathlon® PS and CR femoral components and cemented Triathlon® Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. The Triathlon® X3™ UHMWPE Patellar components are intended to be used with the femoral components of the previously released Duracon® Total Knee System The Triathlon® PS Total Knee System is intended to be used in situations where the posterior cruciate ligament is absent, or cannot be preserved. The Triathlon® CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if it is present. The all polyethylene Triathlon® X3™ UHMWPE Patellar components are intended for implantation with bone cement only.
Indications:
- · Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or, rheumatoid arthritis.
- · Post-traumatic loss of knee joint configuration and function.
- · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
- · Revision of previous unsuccessful knee replacement or other procedure.
- · Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques.
Additional Indications for Posterior Stabilized Components:
- · Ligamentous instability requiring implant bearing surface geometries with increased constraint.
- · Absent or non-functioning posterior cruciate ligament.
Product codes
87 JWH, JWH
Device Description
The device includes tibial and patellar components of a total knee system. These components are used for the replacement of the bearing and/or articulating surfaces of the proximal tibia and patella. Tibial inserts will be made in Cruciate Retaining and Posterior Stabilized designs. Patellar components will be made in both Asymmetric and Symmetric designs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint, distal femur, proximal tibia, patellofemorotibial
Indicated Patient Age Range
Not Found
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
A risk analysis and research and development testing have been performed to demonstrate equivalence of the subject products to the predicate devices. Testing and analysis includes material properties testing, wear testing, disassembly force evaluation, multi-axis fatigue testing, patella shear testing and finite element modeling of contact stresses.
Key Metrics
Not Found
Predicate Device(s)
Triathlon® Tibial Inserts and Patellar
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
K051146 (pg. 1 of 2)
Triathlon® X3™ UHMWPE Tibial and Patellar Components
510(k) Premarket Notification
JUL 1 3 2005
510(k) Summary of Safety and Effectiveness
| Device: | Triathlon® X3™ UHMWPE Tibial Inserts and Patellar Components |
|---|---|
| Classification: | 21 CFR 888.3560 - Knee joint, patellofemorotibial, |
| polymer/metal/polymer semi-constrained cemented prosthesis | |
| Product Code | 87 JWH, |
| Predicate Devices: | Triathlon® Tibial Inserts and Patellar |
| Contact Person: | Karen Ariemma |
| Senior Regulatory Affairs Specialist | |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| (201) 831-5718 | |
| (201) 831-6038 (FAX) | |
| karen.ariemma@stryker.com |
Date Summary Prepared: May 3, 2005
The Triathlon® X3TM UHMWPE Postcrior Stabilized and Cruciate Retaining tibial inserts and the Triathlon® X31™ UHMWPE Patellar components are intended to be used with the cemented Triathlon® PS and CR femoral components and cemented Triathlon® Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. The Triathlon® X3™ UHMWPE Patellar components are intended to be used with the femoral components of the previously released Duracon® Total Knee System The Triathlon® PS Total Knee System is intended to be used in situations where the posterior cruciate ligament is absent, or cannot be preserved. The Triathlon® CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if is present. The all polyethylene Triathlon® X3™ UHMWPE Patellar components are intended for implantation with bone cement only.
Indications:
- · Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or, rheumatoid artlritis.
- · Post-traumatic loss of knee joint configuration and function.
- · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
- · Revision of previous unsuccessful knee replacement or other procedure.
- · Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques.
1
K051146 (pg. 2 of 2)
Triathlon® X3™ UHMWPE Tibial and Patellar Components
Additional Indications for Posterior Stabilized Components:
- · Ligamentous instability requiring implant bearing surface geometries with increased constraint.
- · Absent or non-functioning posterior cruciate ligament.
Contraindications
- Any active or suspected latent infection in or about the knee joint. .
- · Distant foci of infection which may cause hematogenous spread to the implant site.
- · Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
- · Bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis.
- · Skeletal immaturity.
- · Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
- Obesity. An overweight or obese patient can produce loads on the prosthesis that can lead to failure of the fixation of the device or to failure of the device itself.
Device Description
The device includes tibial and patellar components of a total knee system. These components are used for the replacement of the bearing and/or articulating surfaces of the proximal tibia and patella. Tibial inserts will be made in Cruciate Retaining and Posterior Stabilized designs. Patellar components will be made in both Asymmetric and Symmetric designs.
Summary of Data
A risk analysis and research and development testing have been performed to demonstrate equivalence of the subject products to the predicate devices. Testing and analysis includes material properties testing, wear testing, disassembly force evaluation, multi-axis fatigue testing, patella shear testing and finite element modeling of contact stresses.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract bird or a series of interconnected human figures.
JUL 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen Ariemma Senior Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430
Re: K051146
Trade/Device Name: Triathlon® X3™ UHMWPE Tibial Inserts and Patellar Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial, polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: May 3, 2005 Received: May 4, 2005
Dear Ms. Ariemma:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set north 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.
3
Page 2 - Ms. Karen Ariemma
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0210. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely vours,
Sincerely yours,
Stypt Curda
Miriam C. Provost, Ph.D.
1 Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
.. ..
Enclosure
4
K051146 (pg. 1 of 2)
510(k) Number (if known): _
Device Name: Triathlon® Knee System
Indications for Use:
The Triathlon® X3™ UHMWPE Posterior Stabilized and Cruciate Retaining tibial inserts and the Triathlon® X3™ UHMWPE Patellar components are intended to be used with the cemented Triathlon® PS and CR femoral components and cemented Triathlon® Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. The Triathlon® X3™ UHMWPE Patellar components are intended to be used with the femoral components of the previously released Duracon® Total Knee System The Triathlon® PS Total Knee System is intended to be used in situations where the posterior cruciate ligament is absent, or cannot be preserved. The Triathlon CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if it is present. The all polyethylene Triathlon® X3™ UHMWPE Patellar components are intended for implantation with bone cement only.
Indications:
- · Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or, theumatoid arthritis.
- · Post-traumatic loss of knee joint configuration and function.
- · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
- · Revision of previous unsuccessful knee replacement or other procedure.
- · Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques.
Additional Indications for Posterior Stabilized Components:
- · Ligamentous instability requiring implant bearing surface geometries with increased constraint.
- · Absent or non-functioning posterior cruciate ligament.
Contraindications
- · Any active or suspected latent infection in or about the knee joint.
- · Distant foci of infection which may cause hematogenous spread to the implant site.
- · Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
- · Bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis.
(Division Sign-Off)
Division of General, Restorative.
and Neurological Devices
Page 1 of 2
510(k) Number
5
K051146 (pg. 2 of 2)
- · Skeletal immaturity.
- · Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
- · Obesity. An overweight or obese patient can produce loads on the prosthesis that can lead to failure of the fixation of the device or to failure of the device itself.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-the-Counter Use___
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of
Stye Rurde
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K051146