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.

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 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 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.

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 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.

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 condyle/tibial plateau.
These components are intended for implantation with bone cement.

Avon Patello-femoral Joint Prosthesis Indications for Use:
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.

Restoris Multi-Compartmental Knee System Indications for Use:
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.

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.

AI/ML Overview

This document is a 510(k) premarket notification for knee arthroplasty devices, specifically for the Triathlon Knee System and related components. It is important to note that this document does NOT describe a study evaluating the performance of a device driven by an AI algorithm or software.

Instead, this submission is for physical medical devices (knee implants) and their associated labeling. The core purpose of this 510(k) submission is to modify the MR conditional information in the instructions for use for these existing, previously cleared devices due to updated FDA guidance on MR safety testing. The document explicitly states:

"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." (Page 16)
"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." (Page 19)
"Clinical testing was not required as a basis for substantial equivalence." (Page 20)

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI-driven device's performance (e.g., accuracy, sensitivity, specificity, human-in-the-loop studies) cannot be extracted from this document, as it pertains to entirely different types of evaluation (mechanical performance, biocompatibility, and in this specific case, MR safety of physical implants, not AI algorithm performance).

To explicitly answer your questions based on the provided document, even if they don't fully apply to the nature of this submission:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implicit for this submission): The new MR safety testing results must demonstrate that the device is safe for use in an MR environment under the updated parameters to justify the labeling changes, and that the device remains substantially equivalent to its predicates.
- Reported Device Performance: The document states: "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." (Page 19). While the specific quantitative results of this testing are not provided in this summary document, the FDA's clearance (the letter at the beginning) implies the acceptance criteria for MR safety were met.
Sample sized used for the test set and the data provenance:
- This document describes non-clinical (laboratory) testing for MR safety. It does not involve "test sets" in the sense of patient data for AI evaluation. The "sample size" would refer to the number of physical implants tested for MR compatibility. This specific number is not provided in the summary.
- Data Provenance: N/A for clinical data; the testing was performed per FDA guidance, implying controlled laboratory conditions.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This is not a study requiring expert readers or ground truth establishment in the context of AI performance. The "ground truth" for MR safety is established by quantitative measurements in a laboratory setting based on physics principles and regulatory standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not a clinical study requiring human adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This document does not pertain to AI or human reader performance.
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- No. This document does not describe an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- N/A for artificial intelligence context. The ground truth for this submission relates to physical properties and safety in an MR environment, established through standardized physical testing and engineering measurements.
The sample size for the training set:
- N/A. There is no training set mentioned or implied for an AI algorithm in this submission.
How the ground truth for the training set was established:
- N/A. There is no training set mentioned or implied.

In summary, this 510(k) notification is for knee replacement components and deals with updating their MR conditional labeling based on physical testing, not with the performance evaluation of an AI-powered device.

Summary

{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.

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.

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.

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.

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.

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.

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.

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 Orthopaedics325 Corporate DriveMahwah, NJ 07430
Contact Person	Connor TigheStaff Regulatory Affairs SpecialistHowmedica Osteonics Corp325 Corporate DriveMahwah, NJ 07430+1 201-831-5069
Alternate Contact	Margaret KlippelChief Regulatory Affairs SpecialistHowmedica Osteonics Corp325 Corporate DriveMahwah, NJ 07430(201) 831-5559
Date Prepared:	December 4, 2024
Proprietary Name:	Triathlon Knee System; Triathlon Pro Posterior Stabilized FemoralComponents; Triathlon Tritanium Tibial Baseplate; Triathlon LowProfile Tibial Tray; Triathlon Metal Backed Patella; Triathlon PartialKnee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System
Common Name:	Artificial Knee Replacement Components - Femoral, tibial andpatellar

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 StabilizedFemoral Component with Peri-Apatite Left	K051380, K141056, K172326, K200782, K201343
Triathlon® Cruciate RetainingFemoral Component with Peri-Apatite Left	K051380, K141056, K172326, K200782, K201343
Triathlon® Pro Posterior StabilizedFemoral Cemented	K230952, K201343

Tibial baseplates and screws

{14}------------------------------------------------

Triathlon PRIMARY Tibial BaseplateCemented
Triathlon PRIMARY Tibial BaseplateCemented	K062037, K141056, K172326, K201343
Triathlon Universal Tibial Baseplate	K053514, K141056, K172326, K201343
Triathlon Primary Baseplate Beadedwith PA	K051380, K141056, K172326, K201343
TRIATHLON® TRITANIUM® TibialComponent (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 TibialComponent- CS Cemented Use Only		K123166, K141056, K172326, K201343
Triathlon All Poly Tibial Component PSCemented 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

{16}------------------------------------------------

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:

· 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:

· 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:

· 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.

Regulation Number and Section

§ 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.