SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM

K093056 · Smith & Nephew, Inc. · NPJ · Dec 15, 2009 · Orthopedic

Device Facts

• Record ID: K093056
• Device Name: SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: NPJ · Orthopedic
• Decision Date: Dec 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smith & Nephew, Inc. Journey Select Knee System is intended to be used for those patients whereby conditions exist that may not be solely addressed by a device that treats a single compartment. The Journey Select Knee System is intended to replace the patellofemoral and either the medial or lateral condyle of the knee joint in patients where there is evidence of sufficient sound bone to seat and support the components. Indications include: - Post-traumatic arthritis; 1. - 2. Degenerative arthritis; and - 3. Failed osteotomies and unicompartmental replacement. These indications will be used for the Journey Select Knee System, whereby a single condyle and patellofemoral regions of the knee have been affected by one or more of these conditions. The implant devices of the Smith & Nephew, Inc. Journey Select Knee System are single use only and are intended for implantation only with bone cement.

Device Story

System of orthopedic knee prosthesis components; combines previously cleared unicompartmental femoral, patellofemoral, and tibial implants. Used to create bicompartmental knee replacement for patients with multi-compartment disease. Implanted by orthopedic surgeons in clinical/surgical settings. Components fixed using bone cement. Provides structural replacement of damaged joint surfaces; restores joint function; alleviates pain associated with arthritis or failed prior surgeries. System allows physician flexibility in selecting component combinations based on patient anatomy and pathology.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical testing results indicate components are equivalent to clinically used devices and capable of withstanding expected in vivo loading.

Technological Characteristics

Knee joint femorotibial metal/polymer non-constrained cemented prosthesis; patellofemoral polymer/metal semi-constrained cemented prosthesis; patellofemoral-tibial polymer/metal/polymer semi-constrained cemented prosthesis. Modular design using previously cleared components. Single-use. Requires bone cement for fixation.

Indications for Use

Indicated for patients requiring replacement of the patellofemoral and either the medial or lateral condyle of the knee joint due to post-traumatic arthritis, degenerative arthritis, or failed osteotomies/unicompartmental replacement. Requires sufficient sound bone for component seating. Contraindicated if condition is treatable by single-compartment device.

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

• Stryker Compartmental Knee System (K052917)
• Stryker Compartmental Knee System Line Extension (K082567)
• DePuy Orthopaedics Graduated Compartmental Knee (GCK) (K061648)
• DePuy GCK Femoral and Tibial Components (K070849)
• DePuy GCK Femoral and Tibial Components (K070267)

Submission Summary (Full Text)

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Summary of Safety and Effectiveness Smith & Nephew, Inc. JOURNEY® Select Knee System

Date of Summary: September 28, 2009

Contact Person and Address Jason Sells Manager, Regulatory Affairs Smith & Nephew. Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116 T [phone]

DEC 1 5 2009

KD9305

Name of Device: Smith & Nephew, Inc. JOURNEY Select Knee System Common Name: Knee Prosthesis Components

Device Classification Name and Reference: 21 CFR 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis; 21 CFR 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis; 21 CFR 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Device Class: Class II Panel Code: Orthopaedics 87/ HSX, KRR, and NPJ

### Device Description

The Smith & Nephew, Inc. Journey Select Knee System is composed of existing unicompartmental femoral components, patellofemoral implant components, and unicompartmental tibial components previously cleared by FDA. These components may be used in various combinations to create a bicompartmental knee replacement prosthesis and allow the physician to choose the most appropriate option to treat the patient.

## Mechanical Testing

A review of the mechanical testing results indicated that the implant components of the Smith & Nephew, Inc. Journey Select Knee System are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure.

#### Intended Use

The Smith & Nephew, Inc. Journey Select Knee System is intended to be used for those patients whereby conditions exist that may not be solely addressed by a device that treats a single compartment. The Journey Select Knee System is intended to replace the patellofemoral and either the medial or lateral condyle of the knee joint in patients where there is evidence of sufficient sound bone to seat and support the components. Indications include:

- Post-traumatic arthritis; 1.
- 2. Degenerative arthritis; and
- 3. Failed osteotomies and unicompartmental replacement.

These indications will be used for the Journey Select Knee System, whereby a single condyle and patellofemoral regions of the knee have been affected by one or more of these conditions. The implant devices of the Smith & Nephew, Inc. Journey Select Knee System are single use only and are intended for implantation only with bone cement.

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# Substantial Equivalence Information

The individual implant devices in the Smith & Nephew, Inc. Journey Select Knee System are existing devices previously cleared by FDA for unicompartmental knee replacement. The Journey Select Knee System is substantially equivalent to the following compartmental knee systems:

K093056

- Howmedica Osteonics Stryker® Compartmental Knee System, K052917 ■
- Howmedica Osteonics Stryker® Compartmental Knee System Line Extension, K082567 I
- 이 DePuy Orthopaedics Graduated Compartmental Knee (GCK), K061648
- DePuy GCK Femoral and Tibial Components, K070849 ■
- DePuy GCK Femoral and Tibial Components, K070267 l

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus. The seal is simple and monochromatic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

DEC 1 5 2009

Smith & Nephew, Inc. % Mr. Jason Sells 1450 Brooks Road Memphis, Tennessee 38116

Re: K093056

Trade/Device Name: Smith & Nephew, Inc. Journey Select Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: NPJ, HSX, KRR Dated: September 28, 2009 Received: September 30, 2009

Dear Mr. Sells:

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.

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

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Page 2 - Mr. Jason Sells

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Omita D

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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## Indications for Use

510(k) Number (if known):

Device Name: Smith & Nephew, Inc. JOURNEY Select Knee System

Indications for Use:

The Smith & Nephew, Inc. Journey Select Knee System is intended to be used for those patients whereby conditions exist that may not be solely addressed by a device that treats a single · compartment. The Journey Select Knee System is intended to replace the patellofemoral and either the medial or lateral condyle of the knee joint in patients where there is evidence of sufficient sound bone to seat and support the components. Indications include

- 1. Post-traumatic arthritis;
- 2. Degenerative arthritis; and
- Failed osteotomies and unicompartmental replacement. 3.

These indications will be used for the Journey Select Knee System, whereby a single condyle and patellofemoral regions of the knee have been affected by one or more of these conditions. The implant devices of the Smith & Nephew, Inc. Journey Select Knee System are single use only and are intended for implantation only with bone cement.

AND/OR Over-The-Counter Use × Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jonuta for mxm
(Division Sign Off)

Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K093056