Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
Post-traumatic loss of knee joint configuration and function.
Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
Revision of previous unsuccessful knee replacement or other procedure.
Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture -management techniques.

The Triathlon® Tritanium® Tibial Baseplate and Tritaium® Metal-Backed Patella components are indicated for both uncemented and cemented use.

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

Device Description

The Triathlon® Tritanium® Metal-Backed Patella is an extension of the Triathlon® Total Knee System product line for use in primary and revision Total Knee Arthroplasty. It is a sterile, single-use, non-modular metal-backed patella that is manufactured from UHMWPE (ASTM F648) and commercially pure titanium (ASTM F1580). The device is offered in symmetric and asymmetric designs that are available in multiple sizes. The metalbacking features a porous-coated posterior surface and three porous-coated pegs to provide cemented or cementless fixation to bone.

AI/ML Overview

This document, a 510(k) Summary for the Triathlon® Tritanium® Metal-Backed Patella, focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study of a device meeting specific acceptance criteria through performance data. Therefore, many of the requested elements for describing an acceptance criteria study are not present in this submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain a table of acceptance criteria with corresponding device performance metrics in the typical sense of a clinical or analytical performance study. Instead, it lists non-clinical laboratory tests performed to demonstrate substantial equivalence to predicate devices. The "reported device performance" in this context is the successful completion of these tests, implying that the new device performs comparably to the predicates.

Acceptance Criteria (Implied by Test Type)	Reported Device Performance
Material Properties:
Elemental Composition (ASTM E1941, E1447, E1409)	Tested and found comparable to predicates
Metallurgical & Morphological Properties (ASTM E112, F1854)	Tested and found comparable to predicates
Mechanical Properties (ASTM F1147, F1044, F1160, E8)	Tested and found comparable to predicates
Plastic Deformation of Porosity (ASTM F1854)	Tested and found comparable to predicates
Mechanical Performance:
Static Tensile Bond Strength of UHMWPE/Metal Interface	Tested and found comparable to predicates
Static Peg Shear Strength	Tested and found comparable to predicates
Patello-Femoral Contact Stress/Contact Area	Tested and found comparable to predicates
Malaligned Endurance Testing	Tested and found comparable to predicates
Patellar Subluxation Testing	Tested and found comparable to predicates

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

Sample Size: Not explicitly stated for each test. For non-clinical laboratory testing, the sample size typically refers to the number of test articles (patellar components) subjected to each specific test. This tends to be much smaller than clinical study sample sizes and is dependent on the specific ASTM standard or internal protocol used.
Data Provenance: The tests are non-clinical laboratory tests, likely conducted by the manufacturer (Stryker Orthopaedics) or a contract laboratory. The "country of origin of the data" would typically be the location of the testing facility, which is not specified but presumed to be a regulated environment. The data is retrospective in the sense that these are engineering and material characterization tests performed on manufactured devices.

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

This information is not applicable as this submission is for a medical device and relies on engineering and material testing standards (ASTM) to demonstrate substantial equivalence, not on expert ground truth for an AI or diagnostic device.

4. Adjudication Method for the Test Set

This is not applicable. The "test set" here refers to physical components undergoing laboratory testing, not, for example, medical images requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is used for diagnostic or AI-assisted devices to assess human reader performance. This submission is for a physical orthopedic implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This concept applies to AI/software as a medical device, which this orthopedic implant is not.

7. The Type of Ground Truth Used

The "ground truth" for this submission are the established engineering and material specifications, as well as the performance characteristics of the predicate devices. The new device is tested against these benchmarks (often defined by ASTM standards) to show that its properties are within acceptable ranges and comparable to the predicates.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of an orthopedic implant submission based on substantial equivalence through non-clinical testing. This term is relevant for machine learning algorithms.

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

This is not applicable for the same reasons as point 8.

Summary

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	510(k) Summary
Sponsor	Stryker Orthopaedics325 Corporate DriveMahwah, NJ 07430
Contact Person	Shikha KhandelwalRegulatory Affairs SpecialistHowmedica Osteonics CorpShikha.Khandelwal@stryker.comPh: 201-831-6921 Fax: 201-831-3921	NOV 2 6 2013
Date Prepared:	August 20, 2013
Proprietary Name:	Triathlon® Tritanium® Metal-Backed Patella
Common Name:	Total Knee Joint Replacement
Classification Name:	Knee joint patellofemorotibial metal/polymer porous-coateduncemented prosthesis. (888.3565)Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis (888.3560)
Product Codes:	MBH, JWH

Legally Marketed Devices to Which Substantial Equivalence is Claimed:

Triathlon® Tritanium® Tibial Baseplate (K123486) .
. Triathlon® Metal-Backed Patella (K061521)
Triathlon® X3 Patellar Components (cleared as part of the Triathlon® X3™ UHMWPE . Tibial Inserts and Patellar Components, K051146)
. Triathlon® Asymmetric and Symmetric Patellar Components (cleared as part of the Triathlon® CR Total Knee System, K040267)
Scorpio® X3 Recessed Patella (cleared as part of the Scorpio® X3™ UHMWPE Tibial . Inserts and Scorpio® X3™ UHMWPE Patellar Components, K051977)

Device Description: The Triathlon® Tritanium® Metal-Backed Patella is an extension of the Triathlon® Total Knee System product line for use in primary and revision Total Knee Arthroplasty. It is a sterile, single-use, non-modular metal-backed patella that is manufactured from UHMWPE (ASTM F648) and commercially pure titanium (ASTM F1580). The device is offered in symmetric and asymmetric designs that are available in multiple sizes. The metalbacking features a porous-coated posterior surface and three porous-coated pegs to provide cemented or cementless fixation to bone.

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Intended Use: The Triathlon® Tritanium® Metal-Backed Patella is intended for cemented or cementless applications when resurfacing the surgically prepared patella as part of primary or revision Total Knee Arthroplasty (TKR). The Triathlon® Metal-Backed Patella is compatible for use with components of the cemented Triathlon® PS Total Knee System (K031729, K042993), the cemented Triathlon® CR Total Knee System (K040267, K042883), the Triathlon® TS Total Knee System (K070095, K072221), the cementless Triathlon® CR and PS Total Knee Systems with and without HA (K051380), the Triathlon® Universal Knee System components (K053514), the Triathlon® Low Profile Tibial Baseplate (K062037), the Triathlon® Screw Fixation Tibial Baseplate (K072575), the Triathlon® Tritanium® Tibial Baseplate (K123486), the Triathlon® All-Polyethylene Tibia (K123166), the Triathlon® X3™ Tibial Inserts (K051146) and the Triathlon® CS Lipped Tibial Inserts (K063423).

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.

The Triathlon® Tritanium® Tibial Baseplate and Tritanium® Metal-Backed Patella 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:

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· 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.

Summary of Technological Characteristics: Device comparisons and performance testing show that the Triathlon® Tritanium® Metal-Backed Patella is substantially equivalent to its predicates in terms of intended use, indications, design, materials, performance characteristics and operational principles.

Non-Clinical Testing: The following non-clinical laboratory testing was performed to determine substantial equivalence:

Elemental Composition of the Bone-apposing Materials (ASTM E1941, ASTM E1447, o ASTM E1409)
Metallurgical and Morphological Properties of the Bone-apposing Materials (ASTM . E112, ASTM F1854)
Mechanical Properties of the Bone-apposing Materials (ASTM F1147, ASTM F1044, 0 ASTM F1160, ASTM E8)
. Plastic Deformation of the Porosity (ASTM F1854)
Static Tensile Bond Strength of the UHMWPE/Metal Interface .
. Static Peg Shear Strength
0 Patello-Femoral Contact Stress/Contact Area
Malaligned Endurance Testing �
o Patellar Subluxation Testing

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

Conclusion: The Triathlon® Tritanium® Metal-Backed Patella is substantially equivalent to the predicate devices identified in this premarket notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, on the right side. Encircling the caduceus is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The logo is presented in black and white.

Public Health Service

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

November 26, 2013

Stryker Orthopacdics Ms. Shikha Khandelwal Regulatory Affairs Specialist 325 Corporate Drive Mahwah. New Jersey 07430

Re: K132624

Trade/Device Name: Triathlond Tritanium Metal-Backed Patella 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: August 29, 2013 Received: August 30, 2013

Dear Ms. Khandelwal:

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) (2) CFR 803); good manufacturing practice requirements as set

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Page 2 -Ms. Shikha Khandelwal

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/ResourcesforYou/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 CDRF/'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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Lori A. Wigqins

for

Mark 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): K132624

Device Name: Triathlon® Tritanium® Metal-Backed Patella

Indications for Use:

General Total Knee Arthroplasty (TKR) Indications:

Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
· Post-traumatic loss of knee joint configuration and function.
· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
· Revision of previous unsuccessful knee replacement or other procedure.
Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture -management techniques.

The Triathlon® Tritanium® Tibial Baseplate and Tritaium® Metal-Backed Patella components are indicated for both uncemented and cemented use.

The Triathion® 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.
(Page 1/2)

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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.

Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Case V. E. Hanley, Ph.D.
Division of Orthopedic Devices

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.