(90 days)
Not Found
Not Found
No
The device description focuses on the materials, design, and mechanical features of a total knee replacement system. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device details explain that it is a total knee system intended for use in primary or revision total knee arthroplasty, which is a surgical procedure to alleviate painful and disabling joint disease of the knee, thereby performing a therapeutic function.
No
Explanation: This device is a total knee replacement system, which is a therapeutic device intended to replace damaged knee joint components, not to diagnose a condition.
No
The device description clearly details physical components made of materials like cobalt-chromium-molybdenum alloy and ultra high molecular weight polyethylene, which are implanted in the knee joint. This indicates a hardware medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing parts of the knee joint in patients with painful or damaged knees. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of the knee replacement system (femoral component, tibial insert, patellar components) and how they are used in surgery. This aligns with a medical device intended for implantation.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, tissue) to provide diagnostic information. IVDs are designed for this purpose.
Therefore, the Triathlon™ CR Total Knee System is a medical device, specifically a surgical implant, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Triathlon™ CR Total Knee System consists of a femoral component, tibial insert, and allpolyethylene patellar components that are intended to be used with the previously cleared Triathlon™ Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. The Triathlon™ All Polyethylene Patellar components are intended to be used with the femoral components of the previously released Duracon® Total Knee System, as well as the previously released Triathlon™ PS Femoral component in situations where replacement of the articular surface of the patella is required. The Triathlon™ CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if it is present. Specific indications and contraindications are listed below:
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.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The Triathlon™ Cruciate Retaining (CR) Total Knee System consists of three primary components: Triathlon™ Cruciate Retaining (CR) Femoral Component, Triathlon™ Cruciate Retaining (CR) Tibial Insert, and Triathlon™ Patellar components (available in two styles – symmetric and asymmetric). These components are intended to be used with the previously cleared Triathlon™ Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. The Triathlon™ Patellar components are intended to be used with both the Triathlon™ CR Femoral component, the previously cleared Triathlon™ PS Femoral component, or the femoral components of the Duracon® Total Knee System. Duracon® patellar components may be used with both the Triathlon™ PS and Triathlon™ CR femoral components. The use of a patellar component is optional. The Triathlon™ CR components are described below:
The Triathlon™ Total Knee Cruciate Retaining (CR) Femoral Component is fabricated from cast cobalt-chromium-molybdenum alloy, and is intended for cemented application to replace the articulating surface of the distal femur. This cruciate retaining femoral component is utilized when total knee replacement is indicated, and accommodates the posterior cruciate ligament if it is present.
The Triathlon™ Total Knee Cruciate Retaining (CR) Femoral Component is available in right and left configurations, and eight proportional sizes (sizes 1 to 8) to accommodate differences in patient anatomy. The interior surface of the component is grit-blasted to increase surface roughness - this is intended to promote interdigitation of the polymethylmethacrylate (PMMA) bone cement with the surface texture and the apposing bone. This femoral component features cast-in pegs to help in femoral component placement, and to provide rotational stability.
The Triathlon™ Cruciate Retaining (CR) Tibial Insert is neutral in configuration, and is available in seven proportional sizes (sizes 2 to 8) and varying thicknesses (9mm, 11mm, 13mm, 16mm, and 19mm). The insert is fabricated from ultra high molecular weight polyethylene and cobalt-chromium alloy. The minimum thickness of the tibial insert on the bearing surface is 6mm. The tibial insert is designed to accommodate the posterior cruciate ligament if it is present. There is a relief on the anterior aspect of the tibial insert to accommodate the patellar tendon and patellar fat pad.
The Triathlon™ CR Tibial Insert incorporates a locking wire feature on the anterior aspect of the insert. This locking wire is fabricated from cobalt-chromium alloy, and engages under tabs on the anterior rim of the Triathlon™ Primary Tibial Baseplate. This wire-tab locking mechanism secures the insert into the baseplate. This insert-baseplate locking mechanism is identical to the locking mechanism utilized on the Triathlon™ PS Total Knee System.
Triathlon™ Patellar components are available in two styles: symmetric and asymmetric. Both are fabricated from ultra high molecular weight polyethylene. The symmetric design is available in six diameters (27mm, 31mm, 31mm, 36mm, 36mm, and 39mm) and four thicknesses (8mm, 9mm, 10mm, and 11mm). The symmetric design features a central cement recess, and three pegs on the bone interface surface. The Triathlon™ Symmetric patellar component is intended to be implanted via a resurfacing or inset surgical technique. The asymmetric design is available in five superior/inferior dimensions (29mm, 32mm, 35mm, 38mm, and 40mm) and three thicknesses (9mm, 10mm, and 11mm). The asymmetric design features a flare on the lateral aspect of the component. The asymmetric patellar component also has a central recess with three pegs for cement fixation. The Triathlon™ Asymmetric patellar component is intended to be implanted using a resurfacing surgical technique.
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)
Testing was presented to support a claim of substantial equivalence to the predicate devices.
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.
Not Found
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
K040267 (P9 1 of 5)
Triathlon™ Cruciate Retaining (CR) Total Knee System 510(k) Premarket Notification ________________________________________________________________________________________________________________________________________________
Confidential
| MAY - 5 2004 | 510(k) Summary |
|---|---|
| Submission Information | |
| Name and Address of Sponsor: | Howmedica Osteonics Corp. |
| DBA (doing business as) Stryker Orthopaedics | |
| 325 Corporate Drive | |
| Mahwah, New Jersey 07430 | |
| For Information contact: | Margaret F. Crowe |
| Regulatory Affairs Consultant | |
| Howmedica Osteonics Corp. | |
| (DBA Stryker Orthopaedics) | |
| 325 Corporate Drive | |
| Mahwah, New Jersey 07430 | |
| Device Identification | |
| Proprietary Name: | Triathlon™ Cruciate Retaining (CR) Total Knee |
| System | |
| Common Name: | Cruciate Retaining Total Knee Replacement |
| Classification Name and Reference: | Knee Joint Patellofemorotibial |
| Polymer/Metal/Polymer Semi-Constrained | |
| Cemented Prosthesis | |
| 21 CFR §888.3560 | |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | OR (87) JWH |
| Prosthesis, Knee Patellofemorotibial, Semi- | |
| Constrained, Cemented, Polymer/Metal/ Polymer |
The Triathlon™ CR Total Knee System consists of a femoral component, tibial insert, and all-polyethylene patellar components that are intended to be used with the previously cleared Triathlon™ Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. The Triathlon™ All Polyethylenc Patcllar components are intended to be used with the femoral components of the previously released Duracon® Total Knce System, as well as the previously released Triathlon™ PS Femoral component in
1
K040267 ( Pop 2 of 5
Triathlon™ Cruciate Retaining (CR) Total Knee System
510(k) Premarket Notification
Confidential
situations where replacement of the articular surface of the patella is required. The Triathlon™ CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if it is present. Specific indications and contraindications are listed below:
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.
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 postopcrative 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 knec joint secondary to the absence of collateral ligament integrity and function.
- · Obesity. An overweight or obesc 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
2
K040267 (89 3 of 5)
Triathlon™ Cruciate Retaining (CR) Total Knee System Confidential 510(k) Premarket Notification ________________________________________________________________________________________________________________________________________________
The Triathlon™ Cruciate Retaining (CR) Total Knee System consists of three primary components: Triathlon™ Cruciate Retaining (CR) Femoral Component, Triathlon™ Cruciate Retaining (CR) Tibial Insert, and Triathlon™ Patellar components (available in two styles – symmetric and asymmetric). These components are intended to be used with the previously cleared Triathlon™ Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. The Triathlon™ Patellar components are intended to be used with both the Triathlon™ CR Femoral component, the previously cleared Triathlon™ PS Femoral component, or the femoral components of the Duracon® Total Knee System. Duracon® patellar components may be used with both the Triathlon™ PS and Triathlon™ CR femoral components. The use of a patellar component is optional. The Triathlon™ CR components are described below:
The Triathlon" Total Knec Cruciate Retaining (CR) Femoral Component is fabricated from cast cobalt-chromium-molybdenum alloy, and is intended for cemented application to replace the articulating surface of the distal femur. This cruciate retaining femoral component is utilized when total knee replacement is indicated, and accommodates the posterior cruciate ligament if it is present.
The Triathlon"" Total Knee Cruciate Retaining (CR) Femoral Component is available in right and left configurations, and eight proportional sizes (sizes 1 to 8) to accommodate differences in patient anatomy. The interior surface of the component is grit-blasted to increase surface roughness - this is intended to promote interdigitation of the polymethylmethacrylate (PMMA) bone cement with the surface texture and the apposing bone. This femoral component features cast-in pegs to help in femoral component placement, and to provide rotational stability.
The Triathlon" Cruciate Retaining (CR) Tibial Insert is neutral in configuration, and is available in seven proportional sizes (sizes 2 to 8) and varying thicknesses (9mm, 11mm, 13mm, 16mm, and 19mm). The insert is fabricated from ultra high molecular weight polyethylene and cobalt-chromium alloy. The minimum thickness of the tibial insert on the bearing surface is 6mm. The tibial inscrt is designed to accommodate the posterior
3
4 of 5) K040267 ( pg
Triathlon™ Cruciate Retaining (CR) Total Knee System 510(k) Premarket Notification ________________________________________________________________________________________________________________________________________________
Confidential
cruciate ligament if it is present. There is a relief on the anterior aspect of the tibial insert to accommodate the patellar tendon and patellar fat pad.
The Triathlon™ CR Tibial Inscrt incorporates a locking wire feature on the anterior aspect of the insert. This locking wire is fabricated from cobalt-chromium alloy, and engages under tabs on the anterior rim of the Triathlon" " Primary Tibial Baseplate. This wire-tab locking mechanism secures the insert into the baseplate. This insert-baseplate locking mechanism is identical to the locking mechanism utilized on the Triathlon™ PS Total Knee System.
Triathlon™ Patellar components are available in two styles: symmetric and asymmetric. Both are fabricated from ultra high molecular weight polyethylene. The symmetric design is available in six diameters (27mm, 31mm, 31mm, 36mm, 36mm, and 39mm) and four thicknesses (8mm, 9mm, 10mm, and 11mm). The symmetric design features a central cement recess, and three pegs on the bone interface surface. The Triathlon™ Symmetric patellar component is intended to be implanted via a resurfacing or inset surgical technique. The asymmetric design is available in five superior/inferior dimensions (29mm, 32mm, 35mm, 38mm, and 40mm) and three thicknesses (9mm, 10mm, and 11mm). The asymmetric design features a flare on the latcral aspect of the component. The asymmetric patcllar component also has a central recess with three pegs for cement fixation. The Triathlon™ Asymmetric patellar component is intended to be implanted using a resurfacing surgical technique.
Equivalent products include:
-
- Triathlon™ PS Total Knec System
-
- Duracon® CR Femoral Component
-
- Scorpio® CR Femoral Component
-
- Duracon® A/P Lipped Tibial Insert
-
- Duracon® Symmetric Patellar Component
-
- Duracon® Asymmetric Patellar Component
- Kinemax® All Polyethylene Patella 7.
4
K040267 (pg 5 of 5)
Triathlon™ Cruciate Retaining (CR) Total Knce System
510(k) Premarket Notification_________________________________________________________________________________________________________________________________________________
Confidential
Testing was presented to support a claim of substantial equivalence to the predicate devices.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 5 2004
Ms. Margaret F. Crowe Regulatory Affairs Consultant Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430
Re: K040267
KU40267
Trade/Device Name: Triathlon™ Cruciate Retaining (CR) Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: 21 CF X 866.5500
Regulation Name: Knee joint, patellofemorotibial, polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: February 4, 2004 Received: February 5, 2004
Dear Ms. Crowc:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have teviewed your becamed the device is substantially equivalent (for the indications felerenced above and nave actoring ally marketed predicate devices marketed in interstate for use stated in the encreative to regars) as tegally the Medical Device Amendments, or to conninered prior to May 20, 2017 11:11 accordance with the provisions of the Federal Food, Drug, devices mat have been recuired in avere approval of a premarket approval application (PMA). and Cosmetic rear (11ct) that as nevice, subject to the general controls provisions of the Act. The r ou may, merelevely mains of the Act include requirements for annual registration, listing of general controls profile proctice, 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 may or sabyee to does friederal 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 equivalcnce 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 or uns I 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.
6
Page 2 - Ms. Margaret F. Crowe
This letter will allow you to begin marketing your device as described in your Section 510(k) rms retect notification. The FDA finding of substantial equivalence of your device to a legally premaince 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 (301) 594-4659. 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/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Wilkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
K040267 (pg 1 of 2)
Indications for U
510(k) Number (if known): K040267
Device Name: Triathlon™ CR Total Knee System
Indications For Use:
Division of General, Restorative and Neurological Devices
510(k) Number K040267
The Triathlon" CR Total Knec System consists of a femoral component, tibial insert, and allpolyethylene patellar components that are intended to be used with the previously cleared Triathlon™ Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. The Triathlon™ All Polycthylene Patellar components are intended to be used with the femoral components of the previously released Duracon® Total Knee System, as well as the previously released Triathlon™ PS Femoral component in situations where replacement of the articular surface of the patella is required. The Triathlon™ CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if it is present. Specific indications and contraindications are listed below:
Indications:
- · Painful, disabling joint disease of the knee resulting from: nonintlammatory degenerative joint discass: (including osteoarthritis, traumatic arthritis or avascular necrosis) or, theumatoid arthrius
- · 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 prostlyesis 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 knec 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 × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Uso (21 CFR 807 Subpart C)
ge lof
8
K040267 (pg 2 of 2)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milleson
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K040267
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