JOURNEY II XR KNEE SYSTEM

K141471 · Smith & Nephew, Inc. · JWH · Nov 14, 2014 · Orthopedic

Device Facts

• Record ID: K141471
• Device Name: JOURNEY II XR KNEE SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Nov 14, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement. The Journey II Total Knee system components are indicated for use only with cement and are single use devices.

Device Story

Journey II XR Knee System is a bi-cruciate retaining total knee prosthesis designed for patients requiring greater flexion range. System components include medial and lateral cross-linked polyethylene (XLPE) articular inserts and titanium alloy (Ti-6Al-4V) tibial bases. Device utilizes existing Journey II CR femoral components and patella components. Intended for cemented, single-use application in orthopedic surgery. Mechanical performance validated through tibiofemoral contact area analysis, constraint testing, fatigue strength testing, and locking mechanism testing. Device provides structural replacement for damaged knee joints, aiming to restore function and mobility.

Clinical Evidence

Bench testing only. No clinical data was required or provided to support the safety and effectiveness of the device. Mechanical testing included tibiofemoral contact area analysis, constraint testing, construct fatigue strength testing, static testing of the insert locking mechanism, and tibial base plate fatigue performance.

Technological Characteristics

Bi-cruciate retaining total knee prosthesis. Materials: Titanium alloy (Ti-6Al-4V) tibial bases and cross-linked polyethylene (XLPE) articular inserts. Cemented fixation. Single-use. Mechanical design features include insert locking mechanism compatible with existing Journey II CR femoral and patella components.

Indications for Use

Indicated for patients with rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, degenerative arthritis, or failed prior knee surgeries (osteotomies, unicompartmental, or total knee replacement).

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Townley Total Knee (BioPro) (K904448)
• Journey II CR (K121443)
• Genesis II CR (K951987)
• Genesis II High Flex Inserts (K041825)

Submission Summary (Full Text)

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

November 14, 2014

Smith and Nephew, Incorporated Ms. Shereen Bienz Senior Regulatory Affairs Specialist 7135 Goodlet Farm Parkway Cordova, Tennessee 38018

Re: K141471 Trade/Device Name: Journey II XR Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. Regulatory Class: Class II Product Code: JWH Dated: October 16, 2014 Received: October 17, 2014

Dear Ms. Bienz:

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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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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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 Industry and Consumer Education 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. Wiggins -S

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

Enclosure

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# Premarket Notification Indications for Use Statement

510(k) Number (if known): K141471

Device Name: Journey II XR Knee System

Indications for Use:

Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement.

The Journey II Total Knee system components are indicated for use only with cement and are single use devices.

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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| Submitted by: | Smith & Nephew, Inc.<br>Orthopaedic Division<br>1450 East Brooks Road<br>Memphis, Tennessee 38116 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Date of Summary: | November 12, 2014 |
| Contact Person and Address: | Shereen Bienz<br>Senior Regulatory Affairs Specialist<br>T [phone]<br>F [phone] |
| Name of Device: | Smith & Nephew, Inc. Journey II XR Knee System |
| Common Name: | Knee Prosthesis |
| Device Classification Name and<br>Reference: | 21 CFR 888.3560 Knee joint patellofemorotibial<br>polymer/metal/polymer semi-constrained cemented<br>prosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | JWH |

#### Device Description

Subject of this Traditional Premarket Notification are the Journey II XR Knee system. The subject device is a bi-cruciate retaining total knee system which provides the ability for greater flexion to those patients who have the anatomical capability to allow a greater flexion range. Components of this premarket notification include the following components:

- . Medial and lateral cross-linked polyethylene articular inserts which will be available in left and right hand
- o Titanium alloy (Ti-6Al-4V) tibial bases which will be available in left and right hand

The Journey II XR Knee system will use existing Journey II CR femoral components and existing patella components compatible with the Journey II CR femoral as well as device specific instruments.

#### Technological Characteristics

A review of the mechanical data indicates that the Journey II XR Knee System is capable of withstanding expected in vivo loading without failure. The following mechanical testing of the Journey II XR Knee system was performed:

- Tibiofemoral Contact Area Analysis
- Tibiofemoral Constraint Testing
- Construct Fatigue Strength Testing ●
- Static testing of the insert locking mechanism
- Tibial base plate fatigue performance ●

A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices

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# Intended Use

Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement. The Journey II Total Knee system components are indicated for use only with cement and are single use devices.

# Substantial Equivalence Information

The substantial equivalence of the Journey II XR Knee system is based on its similarities in indications for use, design features, and operational principles to the predicate systems listed in the following table.

| Design Aspect<br>Reviewed | Journey II XR<br>Knee System | Townley Total<br>Knee (BioPro) | Journey II CR | Genesis II CR | Genesis II High<br>Flex Inserts |
|-------------------------------------|------------------------------|--------------------------------|-------------------------|-------------------------|---------------------------------|
| 510(k) Number | Subject 510(k) | K904448 | K121443 | K951987 | K041825 |
| Manufacturer | Smith &<br>Nephew, Inc. | BioPro, Inc | Smith &<br>Nephew, Inc. | Smith &<br>Nephew, Inc. | Smith &<br>Nephew, Inc. |
| Similar<br>Indications for<br>Use | Yes | Yes | Yes | Yes | Yes |
| Similar<br>Sterilization<br>Methods | Yes | Yes | Yes | Yes | Yes |
| Bi-cruciate<br>retaining | Yes | Yes | No | No | No |
| Insert material | XLPE | UHMWPE | XLPE and<br>UHMWPE | UHMWPE | UHMWPE |
| Similar<br>Locking<br>Mechanism | Yes | Yes | Yes | Yes | Yes |
| Tibial base<br>material | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V |
| Similar<br>Manufacturing<br>Process | Yes | Unknown | Yes | Yes | Yes |

Table 1: Comparison to Substantially Equivalent Devices

# Conclusion

As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the Journey II XR Knee System. Based on the similarities to the predicate components and a review of the validation testing performed, the device is substantially equivalent to above predicate systems.