(116 days)
Not Found
No
The 510(k) summary describes a modified tibial baseplate for a total knee replacement system. The description focuses on material composition, fixation method (screw-fixation), and compatibility with existing components. There is no mention of any software, algorithms, image processing, or data analysis that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is a knee implant designed to alleviate pain and restore function in individuals with painful and disabling joint disease of the knee, which aligns with the definition of a therapeutic device.
No
The device is described as a component for total knee arthroplasty, which is a surgical procedure to alleviate pain and restore function in a damaged knee joint. It is a prosthetic implant, not a tool used to diagnose medical conditions.
No
The device description clearly describes physical components made of cast cobalt chrome, including tibial baseplates and bone screws. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, 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 description clearly states that the Triathlon® Screw-fixation tibial baseplates are implants used in total knee arthroplasty. They are physical components inserted into the body to replace damaged knee joints.
- Intended Use: The intended use is to alleviate pain and restore function in the knee joint through surgical implantation.
The device is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Triathlon® Screw-fixation tibial baseplates are intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. All total knee components presented in this submission are provided sterile for single-use.
General Total Knee Arthroplasty (TKR) Indications:
- Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative . joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic 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 (PS) Components:
- . Ligamentous instability requiring implant bearing surface geometries with increased constraint.
- . Absent or non-functioning posterior cruciate ligament.
The Triathlon® Screw-fixation Tibial Baseplates are intended for cementless use only.
Product codes (comma separated list FDA assigned to the subject device)
87 MBH
Device Description
The tibial baseplates of the Triathlon® Total Knee System has been modified to include a screwfixation option for use with existing Triathlon® Total Knee components. The subject tibial baseplate is porous coated and will be available with and without Howmedica Osteonics' Periapatite (PA) coating. The Triathlon® fixed bearing cementless tibial baseplates are compatible with Triathlon® CR, PS, and CS tibial inserts and patellae. The Triathlon® components proposed in this submission are manufactured from cast cobalt chrome and have a cobalt chrome porous coating, available with and without a peri-apatitie coating. The Triathlon® tibial component is fixed bearing and will be provided in sizes 1 through 8. Compatible cobalt chrome bone screws are also included in this submission in 6.5mm diameter with lengths of 16mm, and 20mm to 60mm in 5mm increments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
K072575 #1/2
510(k) Summary of Safety and Effectiveness for the Triathlon® Screw-Fixation Tibial Baseplate
| Proprietary Name: | Triathlon® Screw-fixation Tibial Baseplate JAN - 7 2008 |
|---|---|
| Common Name: | Total Knee Joint Replacement Prosthesis |
| Classification Name and Reference | Knee joint patellofemorotibial metal/polymer |
| porous-coated uncemented prosthesis. | |
| 21 CFR §888.3565 | |
| Regulatory Class: | Class II |
| Device Product Code: | 87 MBH - prosthesis, knee, patello/femorotibial, |
| semi-constrained, uncemented, porous, coated, | |
| polymer/metal/polymer, | |
| For Information contact: | Francisco Haro |
| Regulatory Affairs Specialist | |
| Stryker Orthopaedics | |
| 325 Corporate Drive | |
| Mahwah, New Jersey 07432 | |
| Phone: (201) 831-5493 | |
| Fax: (201) 831-6038 | |
| E-Mail: Frank.Haro@stryker.com | |
| Date Summary Prepared: | December 6, 2007 |
Device Description
The tibial baseplates of the Triathlon® Total Knee System has been modified to include a screwfixation option for use with existing Triathlon® Total Knee components. The subject tibial baseplate is porous coated and will be available with and without Howmedica Osteonics' Periapatite (PA) coating. The Triathlon® fixed bearing cementless tibial baseplates are compatible with Triathlon® CR, PS, and CS tibial inserts and patellae. The Triathlon® components proposed in this submission are manufactured from cast cobalt chrome and have a cobalt chrome porous coating, available with and without a peri-apatitie coating. The Triathlon® tibial component is fixed bearing and will be provided in sizes 1 through 8. Compatible cobalt chrome bone screws are also included in this submission in 6.5mm diameter with lengths of 16mm, and 20mm to 60mm in 5mm increments.
1
K072575 # 2/8
Intended Use:
The Triathlon® Screw-fixation tibial baseplates are intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. All total knee components presented in this submission are provided sterile for single-use.
Indications
General Total Knee Arthroplasty (TKR) Indications:
- Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative . joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic 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 (PS) Components:
- . Ligamentous instability requiring implant bearing surface geometries with increased constraint.
- . Absent or non-functioning posterior cruciate ligament.
The Triathlon® Screw-fixation Tibial Baseplates are intended for cementless use only.
Substantial Equivalence:
The determination of the substantial equivalence of the Triathlon® Screw-fixation tibial baseplate is based on its similarities in intended use, design and sterilization to Howmedica Osteonics' Triathlon® Total Knee System (K051380, cleared 30 August 2005) and Duracon® Total Knee System (K032418 cleared, 11 September 2003).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JAN - 7 2008
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stryker Orthopaedics % Mr. Francisco Haro Regulatory Affairs Specialist 325 Corporate Drive Mahwah, NJ 07430
K072575 Trade/Device Name: Triathlon Screw-Fixation Tibial Baseplate Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH Dated: December 6, 2007 Received: December 7, 2007
Dear Mr. Haro:
Re:
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 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.
3
Page 2 - Mr. Francisco Haro
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Mark M. Wilkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Indications
General Total Knee Arthroplasty (TKR) Indications:
- Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative . joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic 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 (PS) Components:
- Ligamentous instability requiring implant bearing surface geometries with increased . constraint.
- Absent or non-functioning posterior cruciate ligament. .
The Triathlon® Screw-fixation Tibial Baseplates are intended for cementless use only.
Prescription Use
OR (Per 21 CFR 801.109)
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)
Samuel B. Payne
(Division Sign-Off) Division of General. Restorative. and Neurological Devices
510(k) Number K072575