· 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 Per-Apatite components are intended for uncemented use only.

The Triathlon® All Polyethylene tibial components are indicated for cemented use only.

Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components:

· Ligamentous instability requiring implant bearing surface geometries with increased constraint.
· Absent or non-functioning posterior cruciate ligament.
· Severe anteroposterior instability of the knee joint.

Additional Indications for Total Stabilizer (TS) Components:

· Severe instability of the knee secondary to compromised collateral ligament integrity or function.

Indications for Bone Augments:

· Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.

· Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss.

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.

Device Description

The additional components being added to the Triathlon Total Knee System are:

Size 0 Cruciate Retaining Femoral Component (cemented use) .
o Size 0 Primary Cemented Tibial Baseplate
Size 0 Tritanium Tibial Baseplate for cemented/cementless use ●
Size 0 CR, CS, and PS Tibial Inserts in X3 ETO and N2Vac ●
New PS Femoral Component with modified intercondylar PS box (cemented use) ●
o New PSR (Posterior Stabilizing Rotation ) tibial insert in sizes 0-8 in X3 ETO

Additionally, engineering analyses and finite element analyses were presented to document the range of motion available with the Triathlon Total Knee System.

AI/ML Overview

This document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is at least as safe and effective as a legally marketed predicate device. It is not a clinical study report that would typically include detailed acceptance criteria and performance data for an AI/ML device.

Therefore, the provided text does not contain the information needed to describe acceptance criteria and a study proving a device meets them, especially for an AI-based medical device. The document concerns modifications to an existing total knee system (implants), not an AI/ML device.

The questions you've asked are highly relevant for the regulatory approval of AI/ML medical devices. If this document were for an AI/ML device, here's how I would break down why the requested information is missing:

Reasoning for Missing Information (Applicable if this were an AI/ML device submission):

The provided text is a 510(k) summary for a "Triathlon Total Knee System - Additional Components." This is a premarket notification for an orthopedic implant (knee replacement components), not an AI/ML (Artificial Intelligence/Machine Learning) device.

The questions posed are specifically for describing the regulatory submission and study design for an AI/ML medical device, which often requires:

Demonstrating performance metrics (e.g., sensitivity, specificity, AUC) against established acceptance criteria.
Detailing the ground truth establishment process (expert consensus, pathology, etc.).
Describing the size and provenance of training and test datasets.
Explaining human-in-the-loop studies (multi-reader multi-case studies).

Since the device under review is a physical medical implant (knee components), these types of studies and acceptance criteria are not applicable. The sponsor instead provides:

Engineering analyses and finite element analyses: To document range of motion.
Non-clinical testing: Fatigue testing, static shear testing, contact area/stress analysis, range of constraint, sterilization validation, and MR Conditional status.
Bacterial endotoxin testing.

The document explicitly states: "Clinical Testing: Clinical testing was not required as a basis for substantial equivalence." This further confirms that the type of performance evaluation relevant to AI/ML devices was not conducted or required for this orthopedic implant.

In summary, none of the requested information regarding acceptance criteria, study design for AI/ML device performance, sample sizes for training/test sets, ground truth establishment, or human expert involvement is present in this 510(k) summary because it pertains to a mechanical orthopedic implant, not an AI/ML software device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

August 22, 2019

Stryker Orthopaedics Margaret Crowe Klippel Senior Principal RA Project Manager 325 Corporate Drive Mahwah, New Jersey 07430

Re: K190402

Trade/Device Name: Triathlon Total Knee System- Additional Components Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: July 25, 2019 Received: July 29, 2019

Dear Margaret Crowe Klippel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 located 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 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.

For CAPT Raquel Peat, PhD, MPH, USPHS Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190402

Device Name Triathlon Total Knee System

Indications for Use (Describe) 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 standard fracture -management techniques.

The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented use.

The Triathlon® Total Knee System beaded with Per-Apatite components are intended for uncemented use only.

The Triathlon® All Polyethylene tibial components are indicated for cemented use only.

Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components:

· Ligamentous instability requiring implant bearing surface geometries with increased constraint.
· Absent or non-functioning posterior cruciate ligament.
· Severe anteroposterior instability of the knee joint.

Additional Indications for Total Stabilizer (TS) Components:

· Severe instability of the knee secondary to compromised collateral ligament integrity or function.

Indications for Bone Augments:

· Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.

· Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss.

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.

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)

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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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K190402

Device Name

Triathlon Tritanium Tibial Baseplate

Indications for Use (Describe) 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) 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 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)

☑ 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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

Sponsor	Stryker Orthopaedics325 Corporate DriveMahwah, NJ 07430
Contact Person	Margaret KlippelSenior Principal Regulatory Affairs Project ManagerHowmedica Osteonics Corp325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5559
Alternate Contact	Kristen MeanySr. Manager, Regulatory AffairsHowmedica Osteonics Corp325 Corporate DriveMahwah, NJ 07430Phone: (201) 972-9164
Date Prepared:	February 18, 2019
Proprietary Name:	Triathlon® Total Knee System – Additional Components
Common Name:	Total Knee Joint Replacement
Classification Name:	Knee joint patellofemorotibial metal/polymer porous-coateduncemented prosthesis. (21 CFR 888.3565)Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3560)
Product Codes:	MBH, IWH

Legally Marketed Device to Which Substantial Equivalence is Claimed:

Triathlon Cruciate Retaining (CR) Femoral Component - K040267, K141056, K172326 Triathlon Posterior Stabilizing (PS) Femoral Component - K042993, K141056, K172326 Triathlon Primary Cemented Tibial Baseplate - K031729, K141056, K172326 Triathlon Tritanium Tibial Baseplate - K123486, K141056, K172326 Triathlon X3 ETO Tibial Inserts (CR, Condylar Stabilizing [CS], and PS) - K172634, K173849 Triathlon N2Vac Tibial Inserts (CR, CS, and PS) – K031729, K040267, K063423, K141056, K172326, K173849

Device Description:

The additional components being added to the Triathlon Total Knee System are:

Size 0 Cruciate Retaining Femoral Component (cemented use) .

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o Size 0 Primary Cemented Tibial Baseplate
Size 0 Tritanium Tibial Baseplate for cemented/cementless use ●
Size 0 CR, CS, and PS Tibial Inserts in X3 ETO and N2Vac ●
New PS Femoral Component with modified intercondylar PS box (cemented use) ●
o New PSR (Posterior Stabilizing Rotation ) tibial insert in sizes 0-8 in X3 ETO

Additionally, engineering analyses and finite element analyses were presented to document the range of motion available with the Triathlon Total Knee System.

Intended Use:

The subject Triathlon Femoral components, Primary tibial baseplate, and tibial inserts have the same intended use as those specified in the 510(k) submissions for the predicate devices listed.

Indications:

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. ●
o 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. 0

Additional Indications for Total Stabilizer (TS) Components:

Severe instability of the knee secondary to compromised collateral ligament integrity or ● function.
Indications for Bone Augments:

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o Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
0 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.

The subject Triathlon Tritanium Tibial Baseplate share indications for use as the

existing Triathlon Tritanium Tibial Baseplates:

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) 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 o 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:

o Ligamentous instability requiring implant bearing surface geometries with increased constraint
Absent or non-functioning posterior cruciate ligament 0
Severe anteroposterior instability of the knee joint ●

The Triathlon Tritanium Tibial Baseplates are indicated for both cemented and uncemented use.

Summary of Technological Characteristics:

The subject Triathlon components are identical in terms of intended use, indications for use, and materials and terminal sterilization methods as compared to the predicate devices. The size 0 subject components differ from the previously cleared predicate devices in terms of overall dimensions - the reduced dimensions are intended to allow the devices to be used in smaller patients. The new PS Femoral component features a reduced PS intercondylar box to allow less

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bone removal anteriorly. The new PSR insert is designed to offer less resistance to internal/external rotation in deep flexion in patients who can achieve this range of motion.

Non-Clinical Testing:

The following non-clinical testing was presented:

Fatigue testing of the femoral components 0
Fatigue testing of the tibial baseplate components per ASTM F1800-12 o
Static shear testing of the insert-baseplate locking mechanism ●
o Contact area/contact stress analysis of the tibial inserts
Range of constraint of the tibial inserts
Range of motion analyses
Ethylene Oxide Sterilization Validation per EN ISO 11135:2014

Previous testing performed to characterize the Tritanium surface was reviewed, and found to be applicable to the subject Triathlon Tritanium Tibial Baseplate.

The subject Triathlon components were evaluated to determine if these devices created a new worst case for image artifact, magnetically induced torque, magnetically induced displacement, and RF induced heating. These subject devices do not create a new worst case as compared to those Triathlon Total Knee components previously cleared in K172326. The subject devices are considered to be MR Conditional.

Additionally, contact area/contact stress and range of motion analysis was presented to support the update in range of motion for the Triathlon system.

Bacterial endotoxin testing (BET) as specified in ANSVAAMI ST72:2011 was used for pyrogenicity testing on the subject devices to achieve an Endotoxin limit of <20 EU/Device.

Clinical Testing: Clinical testing was not required as a basis for substantial equivalence.

Conclusion: The Triathlon® Total Knee System - Additional Components are substantially equivalent to the predicate devices identified in this premarket notification.

Device comparison showed that the proposed devices are substantially equivalent in intended use, materials, and performance characteristics to the predicate devices. The proposed modifications do not affect safety or effectiveness.

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.