(103 days)
Not Found
No
The document describes a total knee arthroplasty system and its components, focusing on materials, indications for use, and a labeling modification. There is no mention of AI or ML technology in the intended use, device description, or performance studies sections.
Yes
The device described is a Total Knee Arthroplasty (TKA) system, which is an implant designed to replace diseased or damaged knee joint components, thereby treating painful and disabling joint conditions.
No
The device is a total knee arthroplasty system, comprised of components like femoral parts, tibial baseplates, and patellar components. Its intended use is to replace diseased or damaged knee joints, not to diagnose medical conditions.
No
The device description explicitly lists physical components made of various materials (Cobalt Chromium Alloy, Titanium Alloy, etc.) used in total knee arthroplasty procedures. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as components for Total Knee Arthroplasty (TKA), a surgical procedure to replace the knee joint. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device components are described as implants (femoral components, tibial baseplates, etc.) made from materials like Cobalt Chromium Alloy, Titanium Alloy, and Polyethylene. These are materials used for surgical implants, not for analyzing samples in vitro.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to replace a joint within the body.
N/A
Intended Use / Indications for Use
Triathlon Knee System
General Total Knee Arthroplasty (TKA) Indications:
- Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative ● ioint 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.
The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented and cemented use.
The Triathlon® Total Knee System beaded and beaded with Peri-Apatite components are intended for uncemented use only.
The Triathlon® All Polyethylene tibial components are indicated for cemented use only.
Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components:
- . Ligamentous instability requiring implant bearing surface geometries with increased constraint.
- Absent or non-functioning posterior cruciate ligament.
- Severe anteroposterior instability of the knee ioint. ●
Additional Indications for Total Stabilizer (TS) Components:
- Severe instability of the knee secondary to compromised collateral ligament integrity or ● function.
Indications for Bone Augments:
- Painful, disabling joint disease of the knee secondary to: degenerative arthritis. . rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
- Salvage of previous unsuccessful total knee replacement or other surgical procedure . accompanied by bone loss.
Triathlon Tritanium Tibial Baseplate
General Total Knee Arthroplasty (TKR) Indications:
- . Painful, disabling joint disease of the knee resulting from: non-inflammatory 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 ●
- o Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques
Additional General Total Knee Arthroplasty (TKR) Indications specific to the PS implant:
- Ligamentous instability requiring implant bearing surface geometries with increased o constraint
- Absent or non-functioning posterior cruciate ligament ●
- Severe anteroposterior instability of the knee joint .
The Triathlon Tritanium Tibial Baseplates are indicated for both cemented and uncemented use.
Triathlon Low Profile Tibial Tray
The Triathlon Low Profile Tibial Tray is intended to be used with commercially available Triathlon® femoral components and associated patellar components, and tibial bearing inserts in primary cemented total knee arthroplasty. The indications for the Triathlon® Low Profile Tibial Tray are outlined below:
Indications for Use:
- · Painful, disabling joint disease of the knee resulting from: degenerative arthritis, theumatoid 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.
Triathlon Metal Backed Patellar
Indications for Use:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or o avascular necrosis:
- Rheumatoid arthritis; .
- Correction of functional deformity; ●
- Revision procedures where other treatments or devices have failed; ●
- Post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and,
- . Irreparable fracture of the knee.
These products are intended to achieve fixation without the use of bone cement.
Product codes (comma separated list FDA assigned to the subject device)
MBH, JWH
Device Description
The devices covered by this submission include femoral components, tibial baseplates, tibial inserts, all-polyethylene tibial components, patellar components, metal backed patellar components, tibial and femoral augments, stems, stem extenders and offset adaptors used in total knee arthroplasty procedures. All devices have been previously determined substantially equivalent in prior 510(k) submissions and are commercially available. The Triathlon Knee system components are manufactured from the following materials Cobalt Chromium Alloy, Titanium Alloy, Commercially Pure Titanium, Ultra-High Molecular Weight Polyethylene and Calcium Phosphate.
The purpose of this submission is to modify the labeling of the Triathlon Knee System to revise the contraindications.
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)
Non-Clinical Testing: Performance testing was not required in support of this submission because this submission covers a labeling modification to the contraindications.
Clinical Testing: Clinical testing was not required as a basis for substantial equivalence.
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.
K031729, K042067, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, K13262
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
Image /page/0/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 that resembles a stylized human figure, with three profiles overlapping to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 5, 2014
Stryker Orthopaedics Karen Ariemma Senior Strategic Regulatory Affairs Manager 325 Corporate Drive Mahwah, New Jersey 07430
Re: K141056 Trade/Device Name: Triathlon Knee System, Tritanium Tibial Baseplate, Triathlon Low Profile Tibial Tray, Triathlon Metal Backed Patellar Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: April 24, 2014 Received: April 25, 2014
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, Lori A. Wiggins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): _ K141056
Device Name: Triathlon Knee System
Indications for Use:
General Total Knee Arthroplasty (TKA) Indications:
- Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative ● ioint 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.
The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented and cemented use.
The Triathlon® Total Knee System beaded and beaded with Peri-Apatite components are intended for uncemented use only.
The Triathlon® All Polyethylene tibial components are indicated for cemented use only.
Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components:
- . Ligamentous instability requiring implant bearing surface geometries with increased constraint.
- Absent or non-functioning posterior cruciate ligament.
- Severe anteroposterior instability of the knee ioint. ●
Additional Indications for Total Stabilizer (TS) Components:
-
Severe instability of the knee secondary to compromised collateral ligament integrity or ● function.
Indications for Bone Augments: -
Painful, disabling joint disease of the knee secondary to: degenerative arthritis. . rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
-
Salvage of previous unsuccessful total knee replacement or other surgical procedure . accompanied by bone loss.
3
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)
Page 2/5
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
4
510(k) Number (if known): K141056
Device Name: Triathlon Tritanium Tibial Baseplate
Indications for Use:
General Total Knee Arthroplasty (TKR) Indications:
- . Painful, disabling joint disease of the knee resulting from: non-inflammatory 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 ●
- o Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques
Additional General Total Knee Arthroplasty (TKR) Indications specific to the PS implant:
- Ligamentous instability requiring implant bearing surface geometries with increased o constraint
- Absent or non-functioning posterior cruciate ligament ●
- Severe anteroposterior instability of the knee joint .
The Triathlon Tritanium Tibial Baseplates are indicated for both cemented and uncemented use.
Over-The-Counter Use Prescription Use AND/OR X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
page 3/5
Division of Orthopedic Devices
5
510(k) Number (if known): K141056
Device Name: Triathlon Low Profile Tibial Tray
Indications for Use:
The Triathlon Low Profile Tibial Tray is intended to be used with commercially available Triathlon® femoral components and associated patellar components, and tibial bearing inserts in primary cemented total knee arthroplasty. The indications for the Triathlon® Low Profile Tibial Tray are outlined below:
Indications for Use:
- · Painful, disabling joint disease of the knee resulting from: degenerative arthritis, theumatoid 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.
Prescription Use X Over-The-Counter Use 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)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
page 4/5
6
510(k) Number (if known): K141056
Device Name: Triathlon Metal Backed Patellar
Indications for Use:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or o avascular necrosis:
- Rheumatoid arthritis; .
- Correction of functional deformity; ●
- Revision procedures where other treatments or devices have failed; ●
- Post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and,
- . Irreparable fracture of the knee.
These products are intended to achieve fixation without the use of bone cement.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
page 5/5
7
510(k) Summary
| Sponsor | Stryker Orthopaedics
325 Corporate Drive
Mahwah, NJ 07430 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Karen Ariemma
Senior Strategic Regulatory Affairs Manager
Stryker Orthopaedics
325 Corporate Drive
Mahwah, NJ 07430
Ph: 201-831-5718 Fax: 201-831-4718 |
| Date Prepared: | June 20, 2014 |
| Proprietary Name: | Triathlon Knee System |
| Common Name: | Total Knee Joint Replacement |
| Classification Name: | Knee joint patellofemorotibial metal/polymer porous-coated
uncemented prosthesis. (888.3565)
Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis (888.3560 |
| Product Codes: | MBH, IWH |
Legally Marketed Device to Which Substantial Equivalence is Claimed: Triathlon Knee System components cleared via the following 510(k) submissions: K031729, K042067, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, and K13262.
Device Description:
The devices covered by this submission include femoral components, tibial baseplates, tibial inserts, all-polyethylene tibial components, patellar components, metal backed patellar components, tibial and femoral augments, stems, stem extenders and offset adaptors used in total knee arthroplasty procedures. All devices have been previously determined substantially equivalent in prior 510(k) submissions and are commercially available. The Triathlon Knee system components are manufactured from the following materials Cobalt Chromium Alloy, Titanium Alloy, Commercially Pure Titanium, Ultra-High Molecular Weight Polyethylene and Calcium Phosphate.
The purpose of this submission is to modify the labeling of the Triathlon Knee System to revise the contraindications.
8
Indications:
There are no changes to the previously cleared indications for use.
Triathlon Knee System
General Total Knee Arthroplasty (TKA) 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.
The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented and cemented use.
The Triathlon® Total Knee System beaded and beaded with Peri-Apatite components are intended for uncemented use only.
The Triathlon® All Polyethylene tibial components are indicated for cemented use only.
Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components:
- Ligamentous instability requiring implant bearing surface geometries with increased ● constraint.
- Absent or non-functioning posterior cruciate ligament.
- Severe anteroposterior instability of the knee joint. ●
Additional Indications for Total Stabilizer (TS) Components:
-
Severe instability of the knee secondary to compromised collateral ligament integrity or function.
Indications for Bone Augments: -
. Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
-
Salvage of previous unsuccessful total knee replacement or other surgical procedure, ● accompanied by bone loss.
Triathlon Tritanium Tibial Baseplate
General Total Knee Arthroplasty (TKR) Indications:
- . Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis
9
- 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 General Total Knee Arthroplasty (TKR) Indications specific to the PS implant:
- Ligamentous instability requiring implant bearing surface geometries with increased . constraint
- Absent or non-functioning posterior cruciate ligament ●
- . Severe anteroposterior instability of the knee joint
The Triathlon Tritanium Tibial Baseplates are indicated for both cemented and uncemented use.
Triathlon Low Profile Tibial Tray
The Triathlon Low Profile Tibial Tray is intended to be used with commercially available Triathlon® femoral components and associated patellar components, and tibial bearing inserts in primary cemented total knee arthroplasty. The indications for the Triathlon® Low Profile Tibial Tray are outlined below:
Indications for Use:
- · Painful, disabling joint disease of the knee resulting from: degenerative arthritis, 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.
Triathlon Metal Backed Patellar
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or . avascular necrosis;
- Rheumatoid arthritis; ●
- Correction of functional deformity; ●
- . Revision procedures where other treatments or devices have failed:
- Post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion. . dysfunction or prior patellectomy; and,
- Irreparable fracture of the knee.
These products are intended to achieve fixation without the use of bone cement.
Summary of Technological Characteristics: There have been no changes to the technological characteristics of the Triathlon Knee System as a result of the revision to the labeling. The subject devices have the same design and are manufactured from the same materials as the predicate devices.
10
Non-Clinical Testing: Performance testing was not required in support of this submission because this submission covers a labeling modification to the contraindications.
Clinical Testing: Clinical testing was not required as a basis for substantial equivalence.
Conclusion: The Triathlon Knee System components are substantially equivalent to the predicate devices identified in this premarket notification.