Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components

K172634 · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · MBH · Nov 16, 2017 · Orthopedic

Device Facts

• Record ID: K172634
• Device Name: Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components
• Applicant: Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
• Product Code: MBH · Orthopedic
• Decision Date: Nov 16, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

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® 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. 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 Story

Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components; orthopedic implants for total knee arthroplasty. Device designs (PS, CR, CS, TS, symmetric/asymmetric patellar) identical to predicates. Components function as bearing surfaces in knee replacement systems; provide stability and articulation. Used in surgical settings by orthopedic surgeons. Subject devices utilize ethylene oxide sterilization; manufactured from Type 1 (GUR1020) UHMWPE resin. PS/TS inserts include Cobalt Chromium locking wire (ASTM F90); TS+ inserts include Cobalt Chromium support pin (ASTM F1537). Implants replace damaged joint surfaces; restore knee function and stability; alleviate pain.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing: material characterization (ASTM F648, F2565), biocompatibility (ISO 10993), sterilization validation (ISO 11135), wear testing (ISO/DIS 14243-3), static shear locking mechanism testing, and single/multi-axis fatigue testing. Bacterial endotoxin testing performed per ANSI/AAMI ST72.

Technological Characteristics

UHMWPE (Type 1 GUR1020 resin) per ASTM F648. Cobalt Chromium locking wire (ASTM F90) and support pin (ASTM F1537). Terminal sterilization via Ethylene Oxide. Designs: PS, CR, CS, TS tibial inserts; symmetric/asymmetric patellar components. Mechanical articulation/bearing surface.

Indications for Use

Indicated for patients with painful, disabling knee joint disease (osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, avascular necrosis), post-traumatic loss of function, moderate varus/valgus/flexion deformity, revision of failed 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 also for severe instability due to compromised collateral ligaments. Bone/cone augments indicated for bone loss or metaphyseal reconstruction.

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® PS and CR X3® UHMWPE Tibial Inserts (K051146)
• Triathlon® Symmetric and Asymmetric X3® UHMWPE Patellar Components (K051146)
• Triathlon® CS X3® UHMWPE Tibial Inserts (K063423)
• Triathlon® TS X3® UHMWPE Tibial Inserts (K072221)

Reference Devices

• Triathlon® PS Tibial Inserts (K031729)
• Triathlon® Symmetric and Asymmetric Patellar Components (K040267)
• Triathlon® CR Tibial Inserts (K042883)
• Triathlon® CS Tibial Inserts (K063423)
• Triathlon® TS Tibial Inserts (K072221)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the U.S. Food & Drug Administration logo is on the right. The FDA logo is blue and white and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".

November 16, 2017

Stryker Orthopaedics Shahrir Alam Senior Regulatory Affairs Specialist 325 Corporate Dr. Mahwah, New Jersey 07430

Re: K172634

Trade/Device Name: Triathlon®X3®UHMWPE Tibial Inserts and Patellar 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: August 30, 2017 Received: September 1, 2017

Dear Shahrir Alam:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Mark N. Melkerson -S

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): K172634

Device Name: Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components

### 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), 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.

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. ●

#### 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.

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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.

Over-The-Counter Use Prescription Use X 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)

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#### 510(k) Summary

| Sponsor | Stryker Orthopaedics<br>325 Corporate Drive<br>Mahwah, NJ 07430 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Shahrir Alam<br>Senior Regulatory Affairs Specialist<br>Howmedica Osteonics Corp<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone]; Fax: [phone] |
| Alternate Contact | Margaret Klippel<br>Sr. Principal Regulatory Affairs Project Manager, Regulatory Affairs<br>Howmedica Osteonics Corp<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone]; Fax: [phone] |
| Date Prepared: | August 31, 2017 |
| Proprietary Name: | Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components |
| 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, IWH |

Legally Marketed Devices to Which Substantial Equivalence is Claimed:

- Triathlon® PS and CR X3® UHMWPE Tibial Inserts (K051146)
- Triathlon® Symmetric and Asymmetric X3® UHMWPE Patellar Components (K051146) ●
- Triathlon® CS X3® UHMWPE Tibial Inserts (K063423) ●
- Triathlon® TS X3® UHMWPE Tibial Inserts (K072221) o

#### Legally Marketed Reference Devices Used to Support Substantial Equivalence:

- Triathlon® PS Tibial Inserts (K031729) ●
- o Triathlon® Symmetric and Asymmetric Patellar Components (K040267)
- Triathlon® CR Tibial Inserts (K042883) ●
- Triathlon® CS Tibial Inserts (K063423) ●
- Triathlon® TS Tibial Inserts (K072221)

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Device Description: The subject Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components are a modified version of the predicate Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components. The device designs are identical to the predicate devices which are available in the posterior stabilized (PS), cruciate retaining (CR), condylar stabilizing (CS) and total stabilizing (TS) designs for the tibial inserts, and the symmetric and asymmetric designs for the patellar components. The subject inserts and patellar components will have a different method of terminal sterilization (ethylene oxide) and will be formed by consolidating Type 1 (GUR1020) resin via conventional methods which meet the specifications of ASTM F648. Like the predicate devices, the subject Triathlon® X3® CR, CS, PS and TS+ tibial inserts will contain a Cobalt Chromium locking wire as per ASTM F90, and the Triathlon TS+ tibial insert will also additionally contain a Cobalt Chromium tibial support pin as per ASTM F1537.

# Intended Use:

The subject devices have the same intended use as those specified in the 510(k) clearances for the predicate devices listed.

## Indications for Use:

General Total Knee Arthroplasty (TKR) Indications:

- Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative o ioint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
- Post-traumatic loss of knee joint configuration and function.
- o 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 ioint. ●

## 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.
- o 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 ●
- o Femoral and Tibial bone voids
- Metaphyseal reconstruction ●

The Triathlon TS Cone Augment components are intended for cemented or cementless use.

Summary of Technological Characteristics: The subject Triathlon® X3® Tibial Inserts and Patellar Components are identical in intended use, indications, design, and operational principles as the predicate device. The subject devices are different from the predicate device in its terminal sterilization method. The subject devices are terminally sterilized by Ethylene Oxide, whereas the predicate device is sterilized using Gas Plasma. Consolidation of X3® polyethylene can be performed via conventional methods. The X3® UHMWPE continues to meet the same ASTM F648 specification.

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

- 1) Material Testing per ASTM F648, ASTM F2565, and Draft FDA Guidance, "Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices" (February 12, 2016).
- 2) Biocompatibility Testing per ISO 10993-1:2009, ISO 10993-7:2008, and FDA Guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (June 16. 2016)
- 3) Ethylene Oxide Sterilization Validation per ISO 11135:2014
- 4) Wear Test based on ISO/DIS 14243-3:2014
- 5) Static Shear Insert Baseplate Locking Mechanism Test
- 6) Single Axis Fatigue Test
- 7) Multi-Axis Fatigue Test
- 8) Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 was used for pyrogenicity testing to achieve an Endotoxin limit of <20 EU/Device

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

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Conclusion: The Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components are substantially equivalent to the predicate devices identified in this premarket notification.

Device comparison showed that the proposed device is substantially equivalent in intended use, materials, and performance characteristics to the predicate device. The proposed modification does not affect safety or effectiveness.