The Triathlon® Screw-fixation tibial baseplates are intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. All total knee components presented in this submission are provided sterile for single-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.

The Triathlon® Screw-fixation Tibial Baseplates are intended for cementless use only.

Device Description

The tibial baseplates of the Triathlon® Total Knee System has been modified to include a screwfixation option for use with existing Triathlon® Total Knee components. The subject tibial baseplate is porous coated and will be available with and without Howmedica Osteonics' Periapatite (PA) coating. The Triathlon® fixed bearing cementless tibial baseplates are compatible with Triathlon® CR, PS, and CS tibial inserts and patellae. The Triathlon® components proposed in this submission are manufactured from cast cobalt chrome and have a cobalt chrome porous coating, available with and without a peri-apatitie coating. The Triathlon® tibial component is fixed bearing and will be provided in sizes 1 through 8. Compatible cobalt chrome bone screws are also included in this submission in 6.5mm diameter with lengths of 16mm, and 20mm to 60mm in 5mm increments.

AI/ML Overview

This 510(k) submission (K072575) describes a modification to an existing device, the Triathlon® Total Knee System, specifically a screw-fixation option for its tibial baseplate. The submission asserts substantial equivalence to previously cleared devices rather than providing a study demonstrating performance against acceptance criteria for a novel device. Therefore, much of the requested information regarding a "study that proves the device meets the acceptance criteria" in the context of device performance metrics (like sensitivity, specificity, etc., which are common for AI/diagnostic devices) is not directly applicable here.

However, we can reframe the request to address the acceptance criteria for substantial equivalence and how the provided information supports that.

1. Table of Acceptance Criteria (for Substantial Equivalence) and Reported Device Characteristics

For a substantial equivalence claim, the "acceptance criteria" are the characteristics of the predicate device, and the "reported device performance" refers to how the new device's characteristics compare to those predicates.

Acceptance Criteria (Predicate Device Characteristics)	Reported Device Performance (Triathlon® Screw-fixation Tibial Baseplate)
Intended Use: Primary and revision total knee arthroplasty to alleviate pain and restore function.	Intended Use: Same as predicate. (Primary & revision TKA for pain relief & function restoration).
Indications for Use: (e.g., Painful/disabling joint disease, post-traumatic loss of configuration, moderate deformity, revision, specific fracture types, ligamentous instability for PS components).	Indications for Use: Same as predicate. All general and PS component specific indications are identical.
Material: Cast cobalt chrome components, cobalt chrome porous coating (with/without Peri-apatite coating).	Material: Same as predicate. Cast cobalt chrome components, cobalt chrome porous coating (with/without Peri-apatite coating).
Design: Tibial baseplate compatible with Triathlon® CR, PS, and CS tibial inserts and patellae. Fixed bearing.	Design: Modified tibial baseplate to include screw-fixation option for use with existing Triathlon® Total Knee components. Fixed bearing. Compatible with same inserts/patellae.
Sterilization: Provided sterile for single-use.	Sterilization: Same as predicate. Provided sterile for single-use.
Fixation Method: Cementless use.	Fixation Method: Cementless use only. (New screw-fixation is an additional cementless option).
Sizes: Available in sizes 1 through 8.	Sizes: Available in sizes 1 through 8.
Additional Components (Predicates): (e.g., Howmedica Osteonics' Triathlon® Total Knee System, Duracon® Total Knee System components).	Additional Components (New): Compatible cobalt chrome bone screws (6.5mm diameter, 16mm, and 20mm-60mm in 5mm increments).

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable for this type of submission. This 510(k) is for a device modification and relies on a demonstration of substantial equivalence to previously cleared predicate devices through direct comparison of design, materials, and intended use, rather than a clinical trial or performance study with a "test set" in the context of diagnostic or AI devices. The "data provenance" would refer to the characteristics of the predicate devices themselves, which are established through their own prior 510(k) clearances.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. There was no "test set" in the sense of patient data requiring expert consensus for ground truth. The "ground truth" for substantial equivalence is the prior FDA clearance of the predicate devices, which implies FDA's expert review and acceptance of their safety and effectiveness.

4. Adjudication Method for the Test Set

Not applicable. No "test set" requiring adjudication by experts was used.

5. 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

Not applicable. This is a medical implant device, not a diagnostic or AI-powered device where an MRMC study would typically be performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical implant device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the FDA clearance of the predicate devices. The new device's safety and effectiveness are established by demonstrating that its design, materials, intended use, and performance are substantially equivalent to those already-cleared devices, meaning it raises no new questions of safety or effectiveness.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for physical implant device modifications in the same way there would be for an AI algorithm. The "training" for the design and manufacturing of such a device is based on established engineering principles, biomechanical testing, and historical clinical performance of similar devices.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there isn't a "training set" in the AI sense. The "ground truth" for the development of such devices is based on established biomechanical and clinical requirements for knee arthroplasty, derived from decades of orthopedic research, clinical experience, and regulatory standards. For the screw-fixation option, the ground truth would also include the established performance and safety of the existing Triathlon® Total Knee System and similar screw-fixation designs in other cleared devices.

Summary

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K072575 #1/2

510(k) Summary of Safety and Effectiveness for the Triathlon® Screw-Fixation Tibial Baseplate

Proprietary Name:	Triathlon® Screw-fixation Tibial Baseplate JAN - 7 2008
Common Name:	Total Knee Joint Replacement Prosthesis
Classification Name and Reference	Knee joint patellofemorotibial metal/polymerporous-coated uncemented prosthesis.21 CFR §888.3565
Regulatory Class:	Class II
Device Product Code:	87 MBH - prosthesis, knee, patello/femorotibial,semi-constrained, uncemented, porous, coated,polymer/metal/polymer,
For Information contact:	Francisco HaroRegulatory Affairs SpecialistStryker Orthopaedics325 Corporate DriveMahwah, New Jersey 07432Phone: (201) 831-5493Fax: (201) 831-6038E-Mail: Frank.Haro@stryker.com
Date Summary Prepared:	December 6, 2007

Device Description

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K072575 # 2/8

Intended Use:

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.
. 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.

The Triathlon® Screw-fixation Tibial Baseplates are intended for cementless use only.

Substantial Equivalence:

The determination of the substantial equivalence of the Triathlon® Screw-fixation tibial baseplate is based on its similarities in intended use, design and sterilization to Howmedica Osteonics' Triathlon® Total Knee System (K051380, cleared 30 August 2005) and Duracon® Total Knee System (K032418 cleared, 11 September 2003).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

JAN - 7 2008

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stryker Orthopaedics % Mr. Francisco Haro Regulatory Affairs Specialist 325 Corporate Drive Mahwah, NJ 07430

K072575 Trade/Device Name: Triathlon Screw-Fixation Tibial Baseplate Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH Dated: December 6, 2007 Received: December 7, 2007

Dear Mr. Haro:

Re:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Francisco Haro

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Mark M. Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

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. �
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. .

The Triathlon® Screw-fixation Tibial Baseplates are intended for cementless use only.

Prescription Use

OR (Per 21 CFR 801.109)

Over-the-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE --- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Samuel B. Payne

(Division Sign-Off) Division of General. Restorative. and Neurological Devices

510(k) Number K072575

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.