(27 days)
Not Found
No
The document describes a physical modification to a knee implant component and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a tibial insert used in total knee arthroplasty to treat painful and disabling joint diseases of the knee, aiming to restore knee joint configuration and function.
No
This device is described as a "Triathlon™ Posterior Stabilized Tibial Insert," which is a component used in total knee arthroplasty (knee replacement surgery). Its intended use is to replace joint components due to disease, trauma, or previous unsuccessful procedures, not to diagnose medical conditions.
No
The device described is a physical implant (tibial insert) used in knee arthroplasty, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is a "Triathlon™ Posterior Stabilized Tibial Insert," which is a component of a total knee arthroplasty system. This is an implantable medical device used in surgery.
- Intended Use: The intended use is for "primary or revision cemented total knee arthroplasty," which is a surgical procedure to replace a damaged knee joint.
- Anatomical Site: The anatomical site is the "Knee joint," which is where the implant is placed.
All of these points indicate that the device is a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The intended use of the size one Triathlon™ Posterior Stabilized Tibial Insert is the same as that of the predicate device described in premarket notification K031729 – it is intended for use with Triathlon™ Posterior Stabilized femoral components, Triathlon™ Primary Cemented Tibial Tray, and Triathlon™ and/or Duracon® patellar components in primary or revision cemented total knee arthroplasty. The Posterior stabilized design is primary of revision collection cruciate ligament if it is absent or non-functioning.
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 (comma separated list FDA assigned to the subject device)
JWH
Device Description
This premarket notification describes a modification to the articulating surface of the size 1 Triathlon™ Posterior Stabilized Tibial Insert. This insert is intended to be used with the size 1 Triathlon™ Primary Cemented Tibial Tray and the Triathlon™ PS Femoral component in primary or revision total knee arthroplasty. This size 1 tibial insert has been modified for improved rotational constraint with the size 1 insert.
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
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
§ 888.3560 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
MAR 2 9 2005
Kosos39
Page
1 of 2
Special 510(k) Summary
Size 1 Triathlon™ Posterior Stabilized (PS) Proprietary Name: Tibial Insert Modular Tibial Insert Common Name: Knee Joint Patellofemorotibial Classification Name and Reference: Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis 21 CFR §888.3560 Class II Proposed Regulatory Class: 87 JWH Device Product Code: Triathlon™ PS Tibial Insert - Sizes 1 Predicate Proprietary Name: Class II Predicate Regulatory Class: 87 JWH Predicate Product Code: Karen Ariemma For Information contact: Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430 Phone: (201) 831-5718 Fax: (201) 831-6038 March 21, 2005 Date Prepared:
Description/Technological Comparison
This premarket notification describes a modification to the articulating surface of the size 1 Triathlon™ Posterior Stabilized Tibial Insert. This insert is intended to be used with the size 1 Triathlon™ Primary Cemented Tibial Tray and the Triathlon™ PS Femoral component in primary or revision total knee arthroplasty. This size 1 tibial insert has been modified for improved rotational constraint with the size 1 insert.
Intended Use
The intended use of the size one Triathlon™ Posterior Stabilized Tibial Insert is the same as that of the predicate device described in premarket notification K031729 - it is intended for use with Triathlon™ Posterior Stabilized femoral components, Triathlon™
1
K050539
Page 2 of 2
Primary Cemented Tibial Tray, and Triathlon™ and/or Duracon® patellar components in primary or revision cemented total knee arthroplasty. The Posterior stabilized design is primary of revision collection cruciate ligament if it is absent or non-functioning.
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.
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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image is a logo for the Department of Health & Human Services - USA. The logo features a stylized graphic of an abstract human figure with three wavy lines emanating from it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
MAR 2 9 7005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Susan Krasny, Ph.D., RAC Director, Regulatory Affairs and Clinical Research Stryker Howmedica Osteonics 325 Corporate Drive Mahwah, New Jersey 07430
Re: K050539
Device Name: Triathlon™ Knee System Posterior Stabilized (PS) Tibial Insert Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: February 28, 2005
Dear Dr. Krasny:
Received: March 2, 2005
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 mcan 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 - Dr. Susan Krasny, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket I his letter will anow you to vegal missantial equivalence of your device to a legally marketed predicate notification: "The I Dry Intellig of scounting 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-_. Also, please note the regulation entitled, "Misbranding by the Office of Comphaneo at (210) 210 - 10 - 1 Part 807.97). You may obtain other general information on four responsibilities under the Act from the Division of Small Manufacturers, International and Consumer your responsibilities and its toll 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Provost
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
K050539 510(k) Number (if known):
Device Name: Triathlon™ Knee System - Posterior Stabilized (PS) Tibial Inserts
Intended Use:
The intended use of the size one Triathlon™ Posterior Stabilized Tibial Insert is the same as that of the predicate device described in premarket notification K031729 – it is intended for use with Triathlon™ PS femoral components, Triathlon™ Primary Cemented Tibial Tray, and Triathlon™ and/or Duracon® patellar components in primary or revision cemented total knee arthroplasty. Specific indications/contraindications are listed below (these are identical to the predicate):
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.
5
K050539 Page 22 of of 2 =
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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR
Over-the-Counter Use
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K050539