JOURNEY CR KNEE SYSTEM

K101499 · Smith & Nephew, Inc. · JWH · Aug 26, 2010 · Orthopedic

Device Facts

• Record ID: K101499
• Device Name: JOURNEY CR KNEE SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Aug 26, 2010
• 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. Smith & Nephew, Inc. Journey CR Knee System components are indicated for use only with cement and are single use devices.

Device Story

Journey CR Knee System is a cruciate-retaining total knee prosthesis designed to facilitate greater flexion range in patients with appropriate anatomical capability. System comprises femoral components (OXINIUM or cobalt-chrome) and UHMWPE articular inserts. Device is implanted by orthopedic surgeons in a clinical/hospital setting. It utilizes existing cemented tibial tray and patellar components from the Journey BCS or Genesis II systems. Mechanical performance is verified through bench testing, including femoral lug torque/push-out, tibial insert locking mechanism, and tibiofemoral/patellofemoral contact area analysis. Output is a restored knee joint function; clinical decision-making relies on surgeon assessment of patient anatomy and pathology. Benefits include potential for increased range of motion compared to standard designs.

Clinical Evidence

No clinical data was required or provided. Safety and effectiveness were established through mechanical bench testing, including removal torque, push-out and torque to failure of femoral lugs, static testing of the tibial insert locking mechanism, tibiofemoral contact area analysis, tibiofemoral constraint testing, patellofemoral contact area analysis, and patellofemoral lateral subluxation testing.

Technological Characteristics

Semi-constrained, cemented total knee prosthesis. Materials: OXINIUM or cobalt-chrome femoral components; UHMWPE articular inserts. Design features cruciate-retaining geometry for increased flexion. Mechanical testing performed per 1993 FDA Draft Guidance for Cemented, Semi-Constrained Total Knee Prostheses. No software or electronic components.

Indications for Use

Indicated for patients requiring total knee arthroplasty due to rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, degenerative arthritis, or failed previous surgeries (osteotomies, unicompartmental, or total knee replacement). 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

• Genesis II Knee System (K951987)
• Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components (K023211)
• Genesis II Deep Flexion Cruciate Retaining Articular Insert (K041825)
• Triathlon Cruciate Retaining (CR) Total Knee (K040267)
• High Performance Knee (Journey BCS Knee System) (K042515)
• Sigma Cruciate Retaining (C/R) Porocoat Femoral Components (K062654)

Submission Summary (Full Text)

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K101499 (1 of 2)

# . We are smith&nephew

| Submitted by: | Smith & Nephew, Inc.<br>Orthopaedic Division<br>1450 East Brooks Road<br>Memphis, Tennessee 38116 | AUG 2 6 2010 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------|
| Date of Summary: | August 25, 2010 | |
| Contact Person and Address: | Shereen Myers, Regulatory Affairs Specialist<br>T [phone] F [phone] | |
| Name of Device: | Smith & Nephew, Inc. Journey CR 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 510(k) premarket notification is the Journey. CR Knee System. The subject device is a cruciate retaining (CR) total knee system which is designed to provide the potential ability for greater flexion to those patients who have the anatomic capability to allow a greater flexion range. Components of this premarket notification include the following components:

- Cruciate retaining femoral components available in sizes 1-10 in right and left designs in . OXINIUM material.
- Cruciate retaining femoral components available in sizes 1-9 in right and left designs in cobalt � chrome material
- Cruciate retaining articular inserts available in sizes 1-2, 3-4, 5-6, and 7-8 in right and left . designs. Journey CR articular inserts will be offered in 9-21mm thicknesses (9, 10, 11, 13, 15, 18, 21) and manufactured from UHMWPE.

The Journey CR 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 CR Knee System is capable of withstanding expected in vivo loading without failure. The following mechanical testing of the Journey CR Knee system was performed:

- Mechanical testing, removal torque, push-out and torque to failure of the Journey CR femoral . lugs
- Static testing of the Journey CR tibial insert locking mechanism .
- Tibiofemoral contact area analysis .

Confidential

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- Tibiofemoral constraint testing
- Patellofemoral contact area analysis
- Patellofemoral lateral subluxation

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; osteoarthrilis; failed osteotomies, unicompartmental replacement, or total knee replacement.

Smith & Nephew, Inc. Journey CR Knee System components are indicated for use only with cement and are single use devices.

#### Substantial Equivalence Information

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

| Manufacturer | Description | Submission<br>Number | Clearance Date |
|----------------------------|-------------------------------------------------------------------------------------|----------------------|----------------|
| Smith & Nephew, Inc. | Genesis II Knee System | K951987 | 8/22/1995 |
| Zimmer | Nexgen Complete Knee Solution<br>Cruciate Retaining (CR)-Flex<br>Femoral Components | K023211 | 10/17/2002 |
| Smith & Nephew, Inc. | Genesis II Deep Flexion Cruciate<br>Retaining Articular Insert | K041825 | 7/6/2004 |
| Howmedica, Inc | Triathlon Cruciate Retaining (CR)<br>Total Knee | K040267 | 5/5/2004 |
| Smith & Nephew | High Performance Knee¹ | K042515 | 3/14/2005 |
| DePuy Orthopaedics<br>Inc. | Sigma Cruciate Retaining (C/R)<br>Porocoat® Femoral Components | K062654 | 9/29/2006 |

#### Conclusion

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

l The High Performance Knee System cleared via K042515 is now marketed by Smith & Nephew as the Journey BCS Knee System.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

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

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

AUG 2 6 2010

Re: K101499

Trade Name: Journey CR Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained

cemented prosthesis

Regulatory Class: II Product Code: JWH Dated: May 27, 2010 Received: June 12, 2010

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 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/ucm1158001.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 3 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Proc 807.97). For questions regarding the reporting of adverse events under the MDR regultivn (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,

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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# K111499

## Premarket Notification Indications for Use Statement

510(k) Number (if known): K101499

Device Name: Journey 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.

Smith & Nephew, Inc. Journey CR Knee System components are indicated for use only with cement and are single use devices.

Prescription Use _ X (Part 21 CFR 801.109)

AND/OR

Over-the-Counter Use (Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Onita for mxm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101499

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