(70 days)
No
The document describes a physical knee implant component and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended for use in total knee arthroplasty to alleviate pain and restore function, which are therapeutic goals.
No
The device, Triathlon® CS (Condylar Stabilizing) Lipped Insert, is an implant used in total knee arthroplasty to alleviate pain and restore function. It's a treatment device, not a diagnostic one.
No
The device description clearly indicates it is a physical implant (tibial insert) used in knee replacement surgery, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical implantation in the knee joint to alleviate pain and restore function in patients with various knee conditions. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical implant (a tibial insert) used in total knee arthroplasty.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Triathlon® CS (Condylar Stabilizing) Lipped Insert is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. The Triathlon® CS (Condylar Stabilizing) Lipped Inserts will be provided sterile and are for single use only.
Indications For Use:
- 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
Product codes (comma separated list FDA assigned to the subject device)
87 JWH, 87 MBH
Device Description
The Triathlon® CS (Condylar Stabilizing) Lipped Insert is compatible with the standard Triathlon® CR (Cruciate Retaining) and Triathlon® PS (Posterior Stabilizing) femoral components as well as the Triathlon® Primary Cemented, Triathlon® Beaded Baseplates, the Triathlon® Universal Baseplate and the Triathlon® Low-Profile Baseplate. The Triathlon® CS Lipped Insert features a similar anterior constraint to the Triathlon® CR insert which allows the surgeon to retain or sacrifice the Posterior Cruciate Ligament (PCL).
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)
Range of Constraint and Contact Area/Peak Stress was presented to compare to other tibial inserts on the market. The results demonstrate that the subject components are substantially equivalent to the predicate 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.
K021451, K023724, K032163, K040267, K042883, K051146, K031729, K050539
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
510(k) Summary of Safety and Effectiveness
| Triathlon® CS (Condylar Stabilizing) Lipped Insert | JAN 2 2 2007 | |
|---|---|---|
| Proprietary Name: | Triathlon® CS (Condylar Stabilizing) Lipped Insert | |
| Common Name: | Modular Tibial Insert | |
| Classification Name/Reference: | Knee Joint Patellofemorotibial | |
| Polymer/Metal/Polymer Semi-Constrained | ||
| Cemented Prosthesis | ||
| 21 CFR §888.3560 |
Knee Joint; Patellofemorotibial; Metal/polymer;
Porous-coated; Uncemented prosthesis
21 CFR 888.3565 | |
| Device Product Code: | 87 JWH
87 MBH | |
| Proposed Regulatory Class: | Class II | |
| For Information contact: | Sheryl R. Bagalio, RAC Regulatory Affairs
Specialist
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430
Phone: (201) 831-5314 Fax: (201) 831-6038 | |
| Date Summary Prepared: | January 10, 2007 | |
Description:
The Triathlon® CS (Condylar Stabilizing) Lipped Insert is compatible with the standard Triathlon® CR (Cruciate Retaining) and Triathlon® PS (Posterior Stabilizing) femoral components as well as the Triathlon® Primary Cemented, Triathlon® Beaded Baseplates, the Triathlon® Universal Baseplate and the Triathlon® Low-Profile Baseplate. The Triathlon® CS Lipped Insert features a similar anterior constraint to the Triathlon® CR insert which allows the surgeon to retain or sacrifice the Posterior Cruciate Ligament (PCL).
Intended Use:
The Triathlon® CS (Condylar Stabilizing) Lipped Insert is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. The
1
Triathlon® CS (Condylar Stabilizing) Lipped Inserts will be provided sterile and are for single use only.
Indications For Use:
- 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
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. Page 1 of 2
- Bone stock compromised by disease, infection or prior implantation which 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 which can lead to failure of the fixation of the device or to failure of the device itself.
Substantial Equivalence:
The Triathlon® CS (Condylar Stabilizing) Lipped Insert is substantially equivalent to other modular tibial inserts regarding intended use, design, materials, and operational principles such as the Duracon® CS Lipped Tibial Insert cleared under K021451, K023724 and K032163, the Triathlon® CR Tibial insert cleared under K040267, K042883 and K051146, and the Triathlon® PS insert cleared under K031729, K050539 and K051146. Range of Constraint and Contact Area/Peak Stress was presented to compare to other tibial inserts on the market. The results demonstrate that the subject components are substantially equivalent to the predicate components.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circle around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2007
Howmedica Osteonics Corporation % Sheryl R. Bagalio, RAC Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K063423
Trade/Device Name: Triathlon® CS (Condylar Stabilizing) Lipped Insert Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis. Regulatory Class: Class II Product Code: JWH, MBH Dated: January 10, 2007 Received: January 12, 2007
Dear Ms. Bagalio:
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
3
Page 2 - Sheryl R. Bagalio, RAC
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. 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) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K063423
Device Name: Triathlon® CS (Condylar Stabilizing) Lipped Insert
Intended Use:
The Triathlon® CS (Condylar Stabilizing) Lipped Insert is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. The Triathlon® CS (Condylar Stabilizing) Lipped Inserts will be provided sterile and are for single use only.
Indications For Use:
- . 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
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. Page 1 of 2
5
- Bone stock compromised by disease, infection or prior implantation which 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 . which can lead to failure of the fixation of the device or to failure of the device itself.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sion-Division of General, Restorative, and Neurological Devices
510(k) Number 1063423
Page 2 of 2