(76 days)
Not Found
No
The document describes a knee implant system and updates to its MR conditional labeling based on new testing. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the physical properties and safety of the implant in an MR environment.
Yes.
The device, a knee replacement system, is used to treat painful and disabling joint diseases of the knee, aiming to restore function and alleviate symptoms caused by various conditions like osteoarthritis, rheumatoid arthritis, or trauma. This directly addresses health conditions through physical intervention.
No
The document describes various knee replacement systems (prostheses and components) and their indications for use in treating painful, disabling joint diseases, trauma, and deformities of the knee. These devices are implants, not tools for diagnosing conditions, but rather for treating them by replacing damaged joint structures. The submission focuses on updating MR conditional information, which pertains to the safety of patients with these implants undergoing MRI scans, not on diagnostic capabilities of the implants themselves.
No
The device description explicitly states that the submission is for modifications to the MR conditional information in the instructions for use for existing knee implant devices. These are physical implants, not software-only devices.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a Total Knee Arthroplasty (TKR) system and related components (femoral components, tibial baseplates, tibial trays, patella, partial knee system, patello-femoral joint prosthesis, multi-compartmental knee system). These are all devices intended for surgical implantation to replace or augment parts of the knee joint.
- 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. This device does not perform any such tests.
- Device Description: The description confirms that the devices are components of a knee replacement system and the submission is related to updating MR conditional information for implanted devices.
- Anatomical Site: The anatomical site is the knee, which is consistent with an implanted orthopedic device, not an IVD.
The information provided describes a range of orthopedic implants for knee replacement surgery, which are distinctly different from in vitro diagnostic devices.
N/A
Intended Use / Indications for 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 standard fracture -management techniques. The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented use. The Triathlon® Total Knee System 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, rheumatic arthritis, complicated by the presence of bone loss. · Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss. Additional Indications for Cone Augments: - · Severe degeneration or trauma requiring extensive resection and replacement - · Femoral and Tibial bone voids - Metaphyseal reconstruction The Triathlon TS Cone Augment components are intended for cemented or cementless use.
Product codes (comma separated list FDA assigned to the subject device)
JWH, KRR, MBH, NPJ, HRY, HSX
Device Description
All of the subject devices have been found substantially equivalent in previous 510(k)s. All the subject devices have been cleared for MR conditional labeling in previous 510(k)s. The purpose of this submission is to modify the MR conditional information in the instructions for use to update the parameters in which a patient who has the device can be safely scanned, per testing conducted accordance to updated FDA guidance. There have been no changes made to the devices requiring 510(k) clearance - only the MR conditional information in the instruction for use is being modified. An additional contraindication is being added to the components of the Triathlon Total Knee System. This contraindication regarding material sensitivity to implant materials is being added.
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)
Non-Clinical Testing: The Stryker Knee System devices were previously evaluated and cleared for conditional use in a Magnetic Resonance Environment through non-clinical testing as outlined in Attachment CH3.08 - Performance Testing. New testing was performed to comprehensively assess the RF-related heating effects induced by the subject devices when implanted into bone, following the FDA guidance document, "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," dated May 20, 2021.
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.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
December 4, 2024
Stryker Orthopaedics Connor Tighe Staff Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K242831
Trade/Device Name: Triathlon Knee System: Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patellofemoral Joint Prosthesis; Restoris Multi-Compartmental Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, KRR, MBH, NPJ, HRY, HSX Dated: September 18, 2024 Received: September 19, 2024
Dear Connor Tighe:
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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
2
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lixin Liu-S
Lixin Liu, Ph.D Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known) K242831
Device Name Triathlon Knee System
Indications for Use (Describe)
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 standard fracture -management techniques.
The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented use. The Triathlon® Total Knee System 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, rheumatic arthritis, complicated by the presence of bone loss.
· Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss.
Additional Indications for Cone Augments:
- · Severe degeneration or trauma requiring extensive resection and replacement
- · Femoral and Tibial bone voids
- Metaphyseal reconstruction
The Triathlon TS Cone Augment components are intended for cemented or cementless use.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
5
510(k) Number (if known) K242831
Device Name
Triathlon Pro Posterior Stabilized Femoral Components
Indications for Use (Describe)
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 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.
- · Severe anteroposterior instability of the knee joint.
The Triathlon® Pro PS Femoral Components are intended for cemented use only.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
6
510(k) Number (if known) K242831
Device Name Triathlon Tritanium Tibial Baseplate
Indications for Use (Describe)
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
- · Fracture of the distal femur and/or proximal tibia that cannot be 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
7
510(k) Number (if known) K242831
Device Name Triathlon Low Profile Tibial Tray
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
8
510(k) Number (if known) K242831
Device Name Triathlon Metal Backed Patella
Indications for Use (Describe)
- · Noninflammatory degenerative joint disease including osteoarthritis 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
9
510(k) Number (if known) K242831
Device Name Triathlon Partial Knee System
Indications for Use (Describe)
Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis
· Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis
· As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis
· Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the femoral condyle/tibial plateau.
These components are intended for implantation with bone cement.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
10
510(k) Number (if known) K242831
Device Name Avon Patello-femoral Joint Prosthesis
Indications for Use (Describe)
The Avon Patello-femoral Joint Prosthesis is intended to be used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity, or dysfunction persists. These components are single use only and are intended for implantation with bone cement.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
11
510(k) Number (if known) K242831
Device Name
Restoris Multi-Compartmental Knee System
Indications for Use (Describe)
Restoris MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis of the tibiofemoral and/or patellofemoral articular surfaces.
The specific knee replacement configurations include:
- Medial unicondylar
- Lateral unicondylar
- Patellofemoral
- · Medial bi-compartmental (medial unicondylar and patellofemoral)
Restoris Multi Compartmental Knee is for single use only and is intended for implantation with bone cement.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
12
510(k) Summary
| Sponsor | Stryker Orthopaedics
325 Corporate Drive
Mahwah, NJ 07430 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Connor Tighe
Staff Regulatory Affairs Specialist
Howmedica Osteonics Corp
325 Corporate Drive
Mahwah, NJ 07430
+1 201-831-5069 |
| Alternate Contact | Margaret Klippel
Chief Regulatory Affairs Specialist
Howmedica Osteonics Corp
325 Corporate Drive
Mahwah, NJ 07430
(201) 831-5559 |
| Date Prepared: | December 4, 2024 |
| Proprietary Name: | Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral
Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low
Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial
Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-
Compartmental Knee System |
| Common Name: | Artificial Knee Replacement Components - Femoral, tibial and
patellar |
Classification Name:
Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis. 21 CFR §888.3560
Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis. 21 CFR 888.3540
Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. 21 CFR 8888.3565
Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis. 21 CFR 888.3530
Knee joint femorotibial metal/polymer non-constrained cemented prosthesis. 21 CFR §888.3520
13
Product Codes:
JWH - prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
KRR - prosthesis, knee, patello/femoral, semi-constrained, cemented, metal/polymer
MBH - prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
NPJ - prosthesis, knee patellofemorotibial, partial, semi-constrained, cemented, polymer/metal/polymer
HRY - prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer
HSX - prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer
Legally Marketed Device to Which Substantial Equivalence is Claimed:
The primary predicate for this submission is K172326. Triathlon Total Knee System. Triathlon Partial Knee System, Restoris Multi-Compartmental Knee System.
The secondary predicates for this submission are K211303. Avon Patello-femoral Joint Prosthesis and K230952, Triathlon Pro Posterior Stabilized Femoral Component.
Triathlon Knee System
Femoral Components
| Description | Previous Premarket Notifications |
|---|---|
| Triathlon CR Femoral Component | K040267, K141056, K172326, K201343 |
| Triathlon TS Femoral Component | K070095, K141056, K172326, K201343 |
| Triathlon PS Femoral Component | K042993, K141056, K172326, K201343 |
| Triathlon® Posterior Stabilized | |
| Femoral Component with Peri- | |
| Apatite Left | K051380, K141056, K172326, K200782, K201343 |
| Triathlon® Cruciate Retaining | |
| Femoral Component with Peri- | |
| Apatite Left | K051380, K141056, K172326, K200782, K201343 |
| Triathlon® Pro Posterior Stabilized | |
| Femoral Cemented | K230952, K201343 |
Tibial baseplates and screws
14
| Triathlon PRIMARY Tibial Baseplate
| Cemented | |
|---|---|
| Triathlon PRIMARY Tibial Baseplate | |
| Cemented | K062037, K141056, K172326, K201343 |
| Triathlon Universal Tibial Baseplate | K053514, K141056, K172326, K201343 |
| Triathlon Primary Baseplate Beaded | |
| with PA | K051380, K141056, K172326, K201343 |
| TRIATHLON® TRITANIUM® Tibial | |
| Component (Impactor Pad Included) | K123486, K141056, K172326, K201343, |
| K190402 | |
| Screw Fixation Baseplate with PA | K072575, K141056, K172326, K201343 |
| Low Profile baseplate | K062037, K141056, K172326, K201343 |
| Vitallium Screw | K072575, K141056, K172326 |
Tibial Inserts and All Poly Tibial Components
| | | K042883, K141056, K172326, K201343, K173849,
K190402 |
|---------------------------------------------------------------|--|---------------------------------------------------------|
| Triathlon CR Tibial Insert - N2Vac | | |
| Triathlon CR Tibial Insert - Gas Plasma | | K051146, K141056, K172326, K201343 |
| Triathlon CR Tibial Insert - X3 ETO | | K172634, K173849, K190402 |
| Triathlon CS Tibial Insert - N2Vac | | K063423, K141056, K172326, K201343 |
| Triathlon CS Tibial Insert - Gas Plasma | | K063423, K141056, K172326, K201343 |
| Triathlon CS Tibial Insert - X3 ETO | | K172634, K173849, K190402 |
| Triathlon PS Tibial Insert - N2Vac | | K031729, K050539, K141056, K172326, K201343, |
| Triathlon PS Tibial Insert - Gas Plasma | | K051146, K141056, K172326, K201343 |
| Triathlon PS Tibial Insert - X3 ETO | | K172634, K173849, K190402 |
| Triathlon TS Tibial Insert- Gas Plasma | | K070095, K072221, K141056, K172326, K201343 |
| Triathlon TS Tibial Insert- X3 ETO | | K172634, K173849 |
| Triathlon PSR Tibial Insert - X3 ETO | | K190402, K201343 |
| TRIATHLON® ALL POLY Tibial
Component- CS Cemented Use Only | | K123166, K141056, K172326, K201343 |
| Triathlon All Poly Tibial Component PS
Cemented Use only | | K123166, K141056, K172326, K201343 |
Femoral Augments/Femoral Cone Augments
| Femoral Distal Augments - 5mm | K070095, K141056, K172326, K190991 |
|---|---|
| Femoral Distal Augments - 10mm | K070095, K141056, K172326, K190991 |
| Femoral Distal Augments - 15mm | K070095, K141056, K172326, K190991 |
| Femoral Posterior Augments - 5mm | K070095, K141056, K172326 |
| Femoral Posterior Augments - 10mm | K070095, K141056, K172326 |
| Tritanium Lobed Femoral Cone | K143393, K172326 |
| Tritanium Central Femoral Cone | K190991 |
Tibial Augments/Tibial Cone Augments
| Tibial Half Block Augment 5mm | K053514, K141056, K172326 |
|---|---|
| Tibial Half Block Augment 10mm | K053514, K141056, K172326 |
| Tritanium Symmetric Tibial Augment | K143393, K172326 |
| Tritanium Asymmetric Tibial Augment | K190991 |
Stems/Stem Extenders/Offset Adapters
| 50mm Long Cemented Stems | K053514, K141056, K172326 |
|---|---|
| 100mm Long Cemented Stems | K053514, K141056, K172326 |
15
| 150mm Long Cemented Stems | K053514, K141056, K172326 |
|---|---|
| 100mm Long Titanium Fluted Stems | K070095, K141056, K172326 |
| 150mm Long Titanium Fluted Stems | K070095, K141056, K172326 |
| Offset Adapters | K070095, K141056, K172326 |
| 25mm Stem Extender | K070095, K141056, K172326 |
Peg
| Triathlon Femoral Peg | K031729, K141056, K172326 |
|---|
Patellar Components
| Metal Backed Patella with PA Coating | K061521, K141056, K172326 |
|---|---|
| Triathlon X3 Gas Plasma All Poly Symmetric Patella | K051146, K051948, K052917, K141056, K172326, K210343 |
| Triathlon X3 ETO All Poly Symmetric Patella | K172634, K173849 |
| Triathlon N2Vac All Poly Symmetric Patella | K040267, K051948, K052917, K141056, K172326 |
| Triathlon X3 Gas Plasma All Poly Asymmetric Patella | K051146, K141056, K172326 |
| Triathlon X3 ETO All Poly Asymmetric Patella | K172634, K173849 |
| Triathlon N2Vac All Poly Asymmetric Patella | K040267, K141056, K172326 |
| Triathlon Tritanium Asymmetric Patella | K132624, K141056, K172326 |
| Triathlon Tritanium Symmetric Patella | K132624, K141056, K172326 |
Triathlon Partial Knee System
| Unicondylar Femoral Component - Cemented | K071881, K082567, K172326, K203099 |
|---|---|
| Unicondylar Tibial Insert | K071881, K082567, K172326, K203099 |
| Unicondylar Tibial Insert - ETO | K203099, K180612 |
| Unicondylar Tibial Baseplate - Cemented | K071881, K082567, K172326, K203099 |
Avon Patello-femoral Joint Prosthesis
| Avon Femoral Component | K041160, K051948, K052917, K211303 |
|---|---|
| Avon Patella - UHMWPE | K041160, K051948, K052917, K211303 |
Restoris Multi-Compartmental Knee System
| Femoral Component | K082172, K090763, K150307, K220930 |
|---|---|
| Tibial Baseplate | K082172, K090763, K150307, K220930 |
| Patella Resurfacing Round Dome | K082172, K090763, K150307, K220930 |
| Tibial Onlay Inserts | K082172, K090763, K150307, K220930 |
| MAKO X3 Uni Tibial Onlay Inserts | K180612 |
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Device Description: All of the subject devices have been found substantially equivalent in previous 510(k)s. All the subject devices have been cleared for MR conditional labeling in previous 510(k)s. The purpose of this submission is to modify the MR conditional information in the instructions for use to update the parameters in which a patient who has the device can be safely scanned, per testing conducted accordance to updated FDA guidance. There have been no changes made to the devices requiring 510(k) clearance - only the MR conditional information in the instruction for use is being modified.
An additional contraindication is being added to the components of the Triathlon Total Knee System. This contraindication regarding material sensitivity to implant materials is being added.
Intended Use: In general, these devices are intended for use in primary or revision knee arthroplasty.
Indications:
Triathlon Knee System
Indications for 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.
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.
17
· Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss.
Additional Indications for Cone Augments:
- Severe degeneration or trauma requiring extensive resection and replacement
- Femoral and Tibial bone voids
- · Metaphyseal reconstruction
The Triathlon TS Cone Augments are intended for cemented or cementless use.
Triathlon Pro Posterior Stabilized Femoral Components
Indications for 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.
-
· Severe anteroposterior instability of the knee joint.
The Triathlon® Pro PS Femoral Components are intended for cemented use only.
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 ioint 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 General Total Knee Arthroplasty (TKR) Indications specific to the PS implant:
- · Ligamentous instability requiring implant bearing surface geometries with increased constraint
18
- · 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
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, 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 Patella
Indications for Use:
· 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,
- dvsfunction or prior patellectomy; and.
• Irreparable fracture of the knee.
These products are intended to achieve fixation without the use of bone cement.
Triathlon Partial Knee System
Indications for Use:
· Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis
· Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis
· As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis
· Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the femoral condvle/tibial plateau.
19
These components are intended for implantation with bone cement.
Avon Patello-femoral Joint Prosthesis
The Avon Patello-femoral Joint Prostheses is intended to be used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists. These components are single use only and are intended for implantation with bone cement.
Restoris Multi-Compartmental Knee System
Restoris MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis, or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces.
The specific knee replacement configurations include:
- · Medial unicondylar
- Lateral unicondylar
- · Patellofemoral
- Medial bi-compartmental (medial unicondylar and patellofemoral)
Restoris Multi Compartmental Knee is for single use only and is intended for implantation with bone cement.
Summary of Technological Characteristics:
There have been no changes requiring 510(k) clearance to the technological characteristics of the Stryker Knee systems 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.
Non-Clinical Testing:
The Stryker Knee System devices were previously evaluated and cleared for conditional use in a Magnetic Resonance Environment through non-clinical testing as outlined in Attachment CH3.08 - Performance Testing.
New testing was performed to comprehensively assess the RF-related heating effects induced by the subject devices when implanted into bone, following the FDA guidance document, "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," dated May 20, 2021.
20
The labeling of the Stryker Knee System devices has been modified to provide the parameters under which a patient who has the device can be safely scanned.
Clinical Testing: Clinical testing was not required as a basis for substantial equivalence.
Conclusion: The Stryker Orthopaedics Knee System devices are substantially equivalent to the predicate device identified in this premarket notification.
Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the predicate device.