JOURNEY II BCS KNEE SYSTEM

K111711 · Smith & Nephew, Inc. · JWH · Sep 16, 2011 · Orthopedic

Device Facts

• Record ID: K111711
• Device Name: JOURNEY II BCS KNEE SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Sep 16, 2011
• 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. Smith & Nephew, Inc. Journey II BCS Knee components are indicated for use only with cement and are single use devices.

Device Story

Journey II BCS Knee System is a posterior stabilized total knee prosthesis designed to facilitate greater flexion (up to 155°) in patients with appropriate anatomical capability. System comprises femoral components (OXINIUM or cobalt chrome) and articular inserts (cross-linked or conventional UHMWPE). Device is intended for use in primary and revision knee surgery; implanted by orthopedic surgeons in a clinical/OR setting. System utilizes existing cemented tibial tray and patellar components from previous Smith & Nephew systems. Prosthesis replaces damaged joint surfaces to restore function and mobility. Clinical benefit derived from improved range of motion and joint stability in patients with ligamentous deficiency.

Clinical Evidence

Bench testing only. No clinical data was required to support the safety and effectiveness of the subject devices. Mechanical testing included patellofemoral contact area analysis, tibiofemoral contact area analysis, static testing of the tibial insert locking mechanism, patellofemoral resistance to lateral subluxation, and tibiofemoral constraint testing.

Technological Characteristics

Semi-constrained, cemented total knee prosthesis. Materials: OXINIUM, cobalt chrome, cross-linked polyethylene (XLPE), and conventional UHMWPE. Design features posterior stabilized femoral components and articular inserts. Mechanical testing performed per FDA guidance for cemented, semi-constrained total knee prostheses. Single-use device.

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). Designed for patients with incompetent anterior/posterior cruciate ligaments but intact collateral ligaments.

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

• High Performance Knee System (K042515)
• Legion Porous Primary Knee System (K073325)
• XLPE Articular Inserts (K071071)
• Genesis II Total Knee System (K951987)
• Genesis II Posterior Stabilized High Flexion Articular Insert (K032295)
• Journey BCS Knee System (K091014)

Submission Summary (Full Text)

{0}------------------------------------------------

KIIII7II *キりね

# re smith&nephew

| Submitted by: | Smith & Nephew, Inc.<br>Orthopaedic Division<br>1450 East Brooks Road<br>Memphis, Tennessee 38116 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Date of Summary: | June 17, 2011 |
| Contact Person and Address: | Shereen Myers, Senior Regulatory Affairs Specialist<br>T [phone] F [phone] |
| Name of Device: | Smith & Nephew, Inc Journey II BCS 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 Abbreviated Premarket Notification is the Journey II BCS Knee system. The Journey II BCS Knee System is a posterior stabilized total knee system which provides the ability for greater flexion (155°) to those patients who have the anatomical capability to allow a greater flexion range. Components of this premarket notification include:

- Posterior stabilized femoral components which will initially be available in sizes 1-10 in right . and left designs in OXINIUM material.
- Posterior stabilized femoral components which will initially be available in sizes 1-9 in right . and left designs in cobalt chrome material
- Posterior stabilized 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 BCS articular inserts will be offered in 9-21 mm thicknesses and manufactured from cross-linked polyethylene (XLPE) material and conventional non-cross-linked Ultra-High Molecular Weight Polyethylene (UHMWPE) material.

The Journey II BCS Knee system will use existing cemented Journey tibial tray and patellar components currently used with the Journey BCS Knee System (K042515) and may also be used with 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 BCS Knee System is capable of withstanding expected in vivo loading without failure. The following mechanical testing of the Journey II BCS Knee system was performed:

- . Patellofemoral Contact Area Analysis
- Tibiofemoral Contact Area Analysis .
- Static Testing of the Tibial Insert Locking Mechanism

1

{1}------------------------------------------------

K111711 *2/

- 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 safety 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. Smith & Nephew, Inc. Journey II BCS Knee components are indicated for use only with cement and are single use devices.

#### Substantial Equivalence Information

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

| Manufacturer | Description | Submission<br>Number | Clearance<br>Date |
|---------------------|------------------------------------------------------------------|----------------------|-------------------|
| Smith & Nephew, Inc | High Performance Knee System | K042515 | 03/14/2005 |
| Smith & Nephew, Inc | Legion Porous Primary Knee<br>System | K073325 | 12/20/2007 |
| Smith & Nephew, Inc | XLPE Articular Inserts | K071071 | 09/19/2007 |
| Smith & Nephew, Inc | Genesis II Total Knee System | K951987 | 08/22/1995 |
| Smith & Nephew, Inc | Genesis II Posterior Stabilized High<br>Flexion Articular Insert | K032295 | 08/21/2003 |
| Smith & Nephew, Inc | Journey BCS Knee System | K091014 | 09/29/2009 |

#### Table 1: Substantially equivalent predicate devices

#### Conclusion

As previously noted, this Abbreviated 510(k) Premarket Notification is being submitted to request clearance for the Journey II BCS Knee System. 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 systems.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

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

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

SEP 1 6 2011

Re: K111711

Trade/Device Name: Journey II BCS 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: June 17, 2011 Received: June 20, 2011

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 (IMA), 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

{3}------------------------------------------------

## Page 2 - Ms. Shereen Myers

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 331-542 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely vours

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

Enclosure

{4}------------------------------------------------

## Premarket Notification Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Journey II BCS 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. Smith & Nephew, Inc. Journey II BCS Knee components are indicated for use only with cement and are single use devices.

× × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × Prescription Use

AND/OR

(Part 21 CFR 801 Subpart D)

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)

Di

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

510(k) Number L 111711