The Triathlon® Tritanium Tibial Baseplates are designed to be implanted with or without bone cement in primary or revision Total Knee Arthroplasty procedures.

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), theumatoid arthritis or post-traumatic arthritis
Post-traumatic loss of knee joint configuration and function
Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability
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 Stabilizing (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® Tibial Baseplates are indicated for both cemented and uncemented use.

Device Description

The Triathlon Tritanium Tibial Baseplate is an extension of the Triathlon® Total Knee System product line for use in primary or revision Total Knee Arthroplasty. It is a sterile, single patient use, tibial baseplate and will be offered in the same size range as the current Triathlon® cementless baseplates (Sizes 1-8). This porous-coated baseplate is for use in both cemented and cementless applications. The Triathlon® Tritanium Tibial Baseplates are packaged with a sterile, single patient use, disposable Impactor Pad in-The Impaction Pad is to be used during the tibial baseplate impaction step only, and is to situ. be discarded once the impaction has been completed. The Impaction Pad is not for implantation.

The Triathlon® Tritanium Tibial Baseplate is compatible for use with the Triathlon® PS, CS and CR Tibial Inserts (NoVac or X3 polyethylene), Triathlon® PS and CR Femoral components (cemented & cementless), Triathlon Symmetric Patellar components (NoVac or X3 polyethylene) (cemented), Triathlon Asymmetric Patellar components (NoVac or X3 polyethylene) (cemented), Triathlon® Metal Backed Asymmetric Patellar with PA (cementless), Duracon® Symmetric & Asymmetric Patellar components (cemented), and Duracon® Inset Patella component (cemented) . These implants may also be used with ShapeMatch Cutting Guides.

AI/ML Overview

The provided text describes a medical device, the Triathlon® Tritanium® Tibial Baseplates, and its FDA 510(k) summary for substantial equivalence. However, it does not contain information about a study that establishes acceptance criteria for AI/ML device performance or a study proving the device meets such criteria.

The document is for a traditional medical device (a knee implant), not an AI/ML diagnostic or therapeutic tool. Therefore, the questions related to AI/ML device performance, sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this submission.

The "Non-Clinical Testing" section describes mechanical and wear testing for the orthopedic implant, which are the relevant performance evaluations for this type of device.

Here's a breakdown of the information that is present and a clear indication of what is not applicable based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of AI/ML device performance. The device is a physical knee implant. Its "performance" is assessed through non-clinical mechanical and wear testing against established standards, not through metrics like sensitivity, specificity, or AUC against a ground truth.

The non-clinical tests performed were to determine "substantial equivalence" and included:

Mechanical properties of materials: ASTM F1580, ASTM F67, ASTM F136, ASTM F1147, ASTM F1044, ASTM F1160.
Device fatigue strength: ASTM F1800, ASTM F2083.
Wear evaluation of conventional polyethylene inserts: ASTM F2025, ISO 14243-3.
Adherence to FDA Guidance Document: 'Guidance document for testing orthopaedic implants with modified metallic surfaces apposing bone or bone cement,' dated April 28, 1994.

The document states that these tests were performed to determine "substantial equivalence" to predicate devices, implying that the results met the established criteria within these standards to demonstrate equivalent material properties, strength, and wear characteristics. Specific numerical acceptance criteria or reported performance data for each test are not detailed in this summary document.

2. Sample size used for the test set and the data provenance

Not applicable for AI/ML performance. The "test set" in this context refers to the physical samples of the implant and its materials subjected to mechanical and wear testing. The sample sizes for these engineering tests are typically specified within the referenced ASTM and ISO standards, but are not provided in this summary. Data provenance (e.g., country of origin, retrospective/prospective) is not relevant for physical product testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for AI/ML performance. "Ground truth" for an orthopedic implant's mechanical properties is established by objective engineering measurements against physical standards, not by expert consensus on data interpretation.

4. Adjudication method for the test set

Not applicable for AI/ML performance.

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

No. This is not an AI/ML device. No MRMC study was performed.

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

No. This is not an AI/ML device.

7. The type of ground truth used

Not applicable for AI/ML performance. The "ground truth" for this device's performance is compliance with established engineering standards for material properties, fatigue strength, and wear, demonstrated through physical laboratory testing.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device, so there is no training set or associated ground truth.

Summary

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K123486 (Page 1 of 2)

510(k) Summary

Sponsor	Homedica Osteonics Corp.325 Corporate DrivesMahwah, NJ 07430
Contact Person	Audrey WitkoSr. Regulatory Affairs Specialist1-201-831-6717
Date Prepared:	November 9, 2012
Proprietary Name:	Triathlon® Tritanium Tibial Baseplates
Common Name:	Total Knee Joint Replacement
Classification Name:	Knee joint Patellofemorotibial metal/polymer porous-coatedUncemented prosthesis. (888.3565, 87MBH)Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis (888.3560, 87JWH)

Legally Marketed Device to Which Substantial Equivalence is Claimed:

· Howmedica Osteonics Corp. - Triathlon® Total Knee System - K051380

· Zimmer, Inc. - NexGen® Trabecular Metal™ Tibial Tray - K072160

Device Description: The Triathlon Tritanium Tibial Baseplate is an extension of the Triathlon® Total Knee System product line for use in primary or revision Total Knee Arthroplasty. It is a sterile, single patient use, tibial baseplate and will be offered in the same size range as the current Triathlon® cementless baseplates (Sizes 1-8). This porous-coated baseplate is for use in both cemented and cementless applications. The Triathlon® Tritanium Tibial Baseplates are packaged with a sterile, single patient use, disposable Impactor Pad in-The Impaction Pad is to be used during the tibial baseplate impaction step only, and is to situ. be discarded once the impaction has been completed. The Impaction Pad is not for implantation.

Intended Use: The Triathlon® Tritanium Tibial Baseplates are designed to be implanted with or without bone cement in primary or revision Total Knee Arthroplasty procedures.

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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), theumatoid · arthritis or post-traumatic arthritis.
· Post-traumatic loss of knee joint configuration and function.
· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
· 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 anterioposterior instability of the knee joint.

The Triathlon® Tritanium Tibial Baseplates are indicated for Cemented or Cementless use.

Summary of Technologies: Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the predicate devices.

Non-Clinical Testing: The following non-clinical laboratory testing was performed to determine substantial equivalence: mechanical properties of the materials (ASTM F1580, ASTM F67. ASTM F136. ASTM F1147. ASTM F1044. ASTM F1160), device fatigue strength (ASTM F1800, ASTM F2083), and wear evaluation of conventional polyethylene inserts comparing subject and predicate devices (ASTM F2025, ISO 14243-3). In addition to the preceding Standards, the FDA Guidance Document entitled 'Guidance document for testing orthopaedic implants with modified metallic surfaces apposing bone or bone cement,' dated April 28, 1994, has been followed.

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

Conclusion: The Triathlon Tibial Baseplate is substantially equivalent to the predicate devices identified in this premarket notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of what appears to be a caduceus, a symbol often associated with healthcare.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 3, 2013

Homedica Osteonics Corporation % Ms. Audrey Witko 325 Corporate Drive Mahwah, New Jersey 07430

Re: K123486

Trade/Device Name: Triathlon® Tritanium® Tibial Baseplates Regulation Number: 21 CFR 888.3565

Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented

prosthesis

Regulatory Class: Class II Product Code: MBH, JWH Dated: April 26, 2013 Received: April 29, 2013

Dear Ms. Witko:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 – Ms. Audrey Witko

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/3/Picture/8 description: The image shows the name "Erin I. Keith" in a stylized font. The first name, "Erin," is written in a bold, sans-serif typeface. The middle initial, "I.," and the last name, "Keith," are designed with a more decorative, outlined font. The overall design gives the name a modern and slightly artistic appearance.

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K123486

Device Name: Triathlon® Tritanium® Tibial Baseplates

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), theumatoid arthritis or post-traumatic arthritis
Post-traumatic loss of knee joint configuration and function
Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability
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 Stabilizing (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® Tibial Baseplates are indicated for both cemented and uncemented use.

X ............................................................................................................................................................................ Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth L. Frank -S

Division of Orthopedic Devices

Page 1 of 1

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.