JOURNEY II CR KNEE SYSTEM

K121443 · Smith & Nephew, Inc. · JWH · Aug 13, 2012 · Orthopedic

Device Facts

• Record ID: K121443
• Device Name: JOURNEY II CR KNEE SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Aug 13, 2012
• Decision: SESE
• Submission Type: Abbreviated
• 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 CR Knee System is a cruciate-retaining (CR) total knee prosthesis; designed for patients with anatomical capability for greater flexion. Components include femoral components (OXINIUM or cobalt chrome) and articular inserts (cross-linked polyethylene or UHMWPE). Device is implanted by orthopedic surgeons in a clinical/OR setting; requires bone cement for fixation. System utilizes existing tibial tray, patellar, and articular insert components from predicate Smith & Nephew knee systems. Device functions as a mechanical joint replacement to restore mobility and reduce pain in patients with degenerative joint disease. Clinical benefit derived from mechanical restoration of knee joint function.

Clinical Evidence

Bench testing only. No clinical data was required or provided to support the safety and effectiveness of the device. Mechanical validation included patellofemoral and tibiofemoral contact area analysis, patellofemoral resistance to lateral subluxation, and tibiofemoral constraint testing.

Technological Characteristics

Cemented, semi-constrained total knee prosthesis. Materials: Femoral components (OXINIUM or cobalt chrome); Articular inserts (cross-linked polyethylene or UHMWPE). Single-use. Mechanical design features include insert locking mechanism. Designed for cruciate-retaining application.

Indications for Use

Indicated for patients requiring primary or revision total knee arthroplasty due to rheumatoid, post-traumatic, or degenerative arthritis, or failed previous surgeries (osteotomy, 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

• Journey II BCS Knee System (K111711)
• Journey CR Knee System (K101499)

Reference Devices

• Journey BCS Knee System (K042515)
• Journey II Deep Dished articular insert components (K113482)
• Genesis II Knee System (K951987)

Submission Summary (Full Text)

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K121443

## We are smith&nephew

Submitted by:

Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116

1 3 2012 AUG

Date of Summary:

Name of Device: Common Name:

Contact Person and Address:

Device Classification Name and

July 25, 2012

Shereen Myers, Senior Regulatory Affairs Specialist T [phone] F [phone]

Smith & Nephew, Inc Journey II CR Knee System

Knee prosthesis

Orthopaedics/87

21 CFR 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis

Device Class:

Panel Code:

Reference:

Product Code:

JWH

Class II

### Device Description

Subject of this Abbreviated Premarket Notification are the Journey II Knee system. This 510(k) was prepared in accordance with the Agency's, "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses," dated April 1993. The subject device is a cruciate retaining (CR) 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:

- Cruciate retaining femoral components which will initially be available in sizes 1-10 in right and . left designs in OXINIUM material.
- Cruciate retaining femoral components which will initially be available in sizes 1-9 in right and . left designs in cobalt chrome material
- Cruciate retaining articular inserts which will initially be available in sizes 1-2, 3-4, 5-6, and 7-. 8 in right and left designs. Journey II CR articular inserts will be offered in 9-21 mm thicknesses and manufactured from cross-linked polyethylene or UHMWPE.

The Journey II CR Knee system will use existing cemented Journey tibial tray and patellar components currently used with the Journey BCS Knee System (K042515), Journey II Deep Dished articular insert components (K113482), and existing patellar components of the Genesis II Knee System (K951987)

#### Technological Characteristics

This 510(k) was prepared in accordance with the Agency's, "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses," dated April 1993. A review of the mechanical data indicates that the Journey II CR Knee System is capable of withstanding expected in vivo loading without failure. The following mechanical testing of the Journey II CR Knee system was performed:

- Patellofemoral Contact Area Analysis
- Tibiofemoral Contact Area Analysis

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K121443

- Patellofemoral Resistance to Lateral Subluxation ♥
- Tibiofemoral Constraint Testing .

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 safely and effectiveness of the subject devices

#### Intended Use

Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, 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.
### Substantial Equivalence Information

The substantial equivalence of the Journey II CR 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 CR Knee System | Journey II BCS Knee<br>System | Journey CR Knee System |
|-------------------------------------|-------------------------------------------------------|-------------------------------------------------------|----------------------------------------------|
| 510(k) Number | Subject 510(k) | K111711 | K101499 |
| Manufacturer | Smith & Nephew, Inc | Smith & Nephew, Inc | Smith & Nephew, Inc |
| Similar Indications<br>for Use | Subject device | Y | Y |
| Insert Locking<br>Mechanism | Y | Y | Y |
| Similar Sterilization<br>Method | Subject device | Y | Y |
| Material | Femoral - OXNIUM and CoCr<br>Insert - XLPE and UHMWPE | Femoral - OXNIUM and CoCr<br>Insert - XLPE and UHMWPE | Femoral - OXNIUM and CoCr<br>Insert - UHMWPE |
| Similar<br>Manufacturing<br>Process | Subject device | Y | Y |

#### Table 1: Comparison to Substantially Equivalent Devices

#### Conclusion

As previously noted, this Abbreviated 510{k} Premarket Notification is being submitted to request clearance for the Journey II CR 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.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

AUG 1 3 2012

Smith & Nephew, Inc. % Ms. Shereen Myers Senior Regulatory Affairs Specialist 1450 E. Brooks Road Memphis, Tennessee 38116

Re: K121443

Trade/Device Name: Journey II CR Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: II

Product Code: JWH Dated: May 14, 2012 Received: May 15, 2012

Dear Ms. Myers:

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

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Page 2 - Ms. Shereen Myers

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers; International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Erica Keith

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

Enclosure

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# Premarket Notification Indications for Use Statement

121443 510(k) Number (if known):

Device Name: Journey II CR 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. 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.

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)

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

| 510(k) Number | K121443 |
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|---------------|---------|