JOURNEY II XR Knee System

K152726 · Smith & Nephew, Inc. · JWH · Oct 21, 2015 · Orthopedic

Device Facts

• Record ID: K152726
• Device Name: JOURNEY II XR Knee System
• Applicant: Smith & Nephew, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Oct 21, 2015
• Decision: SESE
• Submission Type: Special
• 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. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. 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 cemented, single-use total knee prosthesis. Subject device introduces minor modifications to the tibial baseplate and insert locking mechanism. System utilizes titanium alloy (Ti-6Al-4V) tibial bases and cross-linked polyethylene articular inserts (medial/lateral, left/right). Operates as a semi-constrained knee joint replacement. Used by orthopedic surgeons in clinical settings for primary or revision knee arthroplasty. Device provides mechanical stability and articulation for patients with degenerative joint disease. Surgeon implants components using device-specific instruments; output is a restored knee joint function. Benefits include pain relief and improved mobility for patients with severe arthritis or failed previous joint replacements.

Clinical Evidence

Bench testing only. No clinical data was required to support the safety and effectiveness of the modified components. Verification included mechanical testing of the locking mechanism and fatigue testing of the tibial construct.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V) tibial bases, cross-linked polyethylene articular inserts. Design: Semi-constrained cemented prosthesis. Connectivity: None. Sterilization: Not specified. Software: None. Mechanical verification: Component interlock strength, fatigue strength testing, and FEA.

Indications for Use

Indicated for patients requiring primary or revision total knee arthroplasty due to rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, degenerative arthritis, or failed prior surgeries (osteotomies, unicompartmental, or total knee replacement). Designed for cases where anterior/posterior cruciate ligaments are incompetent but collateral ligaments remain intact. For use only with cement; single-use only.

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

• Journey II XR Knee System (K141471)

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

October 21, 2015

Smith & Nephew, Incorporated Brad Sheals Principal Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016

Re: K152726 Trade/Device Name: Journey II XR Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: September 18, 2015 Received: September 22, 2015

Dear Mr. Sheals:

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 Parts 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,

# 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) K152726

Device Name Journey II XR Knee System

#### Indications for Use (Describe)

Total knee components are indicated for theumatoid arthritis, osteoarthritis, 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.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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| Submitted by: | Smith & Nephew, Inc.<br>Orthopaedic Division<br>1450 East Brooks Road<br>Memphis, Tennessee 38116 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Date of Summary: | September 18, 2015 |
| Contact Person and Address: | Brad Sheals<br>Principal Regulatory Affairs Specialist<br>T 901-399-6897<br>F 901-566-7911 |
| Name of Device: | Smith & Nephew, Inc. Journey II XR |
| 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

The Journey II XR tibial baseplate and inserts were previously cleared for market via premarket notification K141471. Subject of this premarket notification are minor modifications to the insert locking mechanism on the tibial baseplate and insert.

The Journey II XR components are available in medial and lateral cross-linked polyethylene articular inserts which will be available in left and right hand and 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.

## 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. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. The Journey II Total Knee system components are indicated for use only with cement and are single use devices.

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# Technological Characteristics

Mechanical testing has been conducted to address the locking mechanism design change. The following verification testing has been conducted:

- Component Interlock Strength of the Tibial Insert Locking Mechanism ●
- Fatigue Strength Testing Of The Tibial Metal Base Tray, Cement And ● Polyethylene Insert Construct - Rationale
- Tibial Base Fatigue Testing- FEA

A review of the results indicates that the Journey II XR tibial baseplate and inserts are equivalent to the existing, legally marketed predicate devices with regards to mechanical performance and 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.

# Substantial Equivalence Information

The subject devices are identical in function, intended use, indications for use, and material composition, and very similar in overall design to the Journey II XR knee system cleared via premarket notification K141471. The device subject of this premarket notification is a modification to the aforementioned device.

#### Table 1: Substantially Equivalent Predicates to the Modified Journey II XR components

| Manufacturer | Description | Submission<br>Number | Clearance Date |
|----------------------|---------------------------|----------------------|----------------|
| Smith & Nephew, Inc. | Journey II XR Knee System | K141471 | 11/14/2014 |

# Conclusion

As previously noted, this Special 510(k) Premarket Notification is being submitted to request clearance for the modified Journey II XR tibial baseplate and inserts. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to above predicate knee system.