TRIATHLON TRITANIUM METAL-BACKED PATELLA

K132624 · Stryker Orthopaedics · MBH · Nov 26, 2013 · Orthopedic

Device Facts

• Record ID: K132624
• Device Name: TRIATHLON TRITANIUM METAL-BACKED PATELLA
• Applicant: Stryker Orthopaedics
• Product Code: MBH · Orthopedic
• Decision Date: Nov 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

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).

Device Story

Triathlon® Tritanium® Metal-Backed Patella is a sterile, single-use, non-modular orthopedic implant for primary or revision Total Knee Arthroplasty (TKA). Device consists of UHMWPE bearing surface and porous-coated titanium backing with three pegs for cemented or cementless bone fixation. Implanted by orthopedic surgeons in an operating room setting to resurface the patella. Device functions as a mechanical bearing component within the Triathlon Total Knee System to restore joint function, stability, and alleviate pain associated with degenerative or traumatic knee disease. Clinical benefit derived from mechanical replacement of damaged articular surfaces.

Clinical Evidence

No clinical data provided. Substantial equivalence established via non-clinical bench testing, including elemental composition (ASTM E1941, E1447, E1409), metallurgical/morphological properties (ASTM E112, F1854), mechanical properties (ASTM F1147, F1044, F1160, E8), static peg shear strength, patello-femoral contact stress/area, malaligned endurance, and patellar subluxation testing.

Technological Characteristics

Materials: UHMWPE (ASTM F648) and commercially pure titanium (ASTM F1580). Design: Non-modular, symmetric/asymmetric, porous-coated posterior surface and pegs. Energy source: N/A (mechanical). Connectivity: N/A. Sterilization: Sterile, single-use.

Indications for Use

Indicated for patients with painful, disabling knee joint disease (osteoarthritis, traumatic arthritis, avascular necrosis, rheumatoid arthritis, post-traumatic arthritis); post-traumatic loss of function; moderate varus, valgus, or flexion deformity; revision of unsuccessful knee replacement; or distal femur/proximal tibia fractures. PS/TS components indicated for ligamentous instability, absent posterior cruciate ligament, or severe anteroposterior instability. TS components indicated for severe instability due to compromised collateral ligament integrity. Bone augments indicated for cases complicated by bone loss.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Triathlon® Tritanium® Tibial Baseplate (K123486)
• Triathlon® Metal-Backed Patella (K061521)
• Triathlon® X3 Patellar Components (K051146)
• Triathlon® Asymmetric and Symmetric Patellar Components (K040267)
• Scorpio® X3 Recessed Patella (K051977)

Reference Devices

• Triathlon® PS Total Knee System (K031729, K042993)
• Triathlon® CR Total Knee System (K040267, K042883)
• Triathlon® TS Total Knee System (K070095, K072221)
• Triathlon® CR and PS Total Knee Systems (K051380)
• Triathlon® Universal Knee System (K053514)
• Triathlon® Low Profile Tibial Baseplate (K062037)
• Triathlon® Screw Fixation Tibial Baseplate (K072575)
• Triathlon® All-Polyethylene Tibia (K123166)
• Triathlon® X3™ Tibial Inserts (K051146)
• Triathlon® CS Lipped Tibial Inserts (K063423)

Submission Summary (Full Text)

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| | 510(k) Summary | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Sponsor | Stryker Orthopaedics<br>325 Corporate Drive<br>Mahwah, NJ 07430 | |
| Contact Person | Shikha Khandelwal<br>Regulatory Affairs Specialist<br>Howmedica Osteonics Corp<br>[e-mail]<br>Ph: 201-831-6921 Fax: [phone] | 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-coated<br>uncemented prosthesis. (888.3565)<br>Knee joint patellofemorotibial polymer/metal/polymer semi-<br>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 [phone] or [phone] 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 [phone] or [phone] 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