REVISION PROTHESIS

K110837 · Smith & Nephew, Inc. · JWH · Apr 22, 2011 · Orthopedic

Device Facts

• Record ID: K110837
• Device Name: REVISION PROTHESIS
• Applicant: Smith & Nephew, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Apr 22, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Total knee components are indicated for: 1. Rheumatoid arthritis 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. The posterior-stabilized knee system is 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 Revision Journey BCS STD Inserts are indicated for use with bone cement, and are single use devices.

Device Story

Revision Journey BCS STD Inserts are UHMWPE articular inserts for total knee arthroplasty. Modifications to predicate High Performance Knee include updated tibial baseplate locking mechanism, altered post height, and increased blend radius at post base. Used in primary and revision knee surgery; implanted by orthopedic surgeons in clinical settings. Devices function as part of a semi-constrained cemented prosthesis system to restore joint function in patients with ligamentous instability. Single-use only.

Clinical Evidence

No clinical data was required or provided. Safety and effectiveness supported by bench testing performed in accordance with FDA's Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses (April 1993).

Technological Characteristics

Articular inserts manufactured from UHMWPE. Semi-constrained, cemented, patellofemorotibial prosthesis. Available in left/right configurations, sizes 1-8, thicknesses 9-18mm. Features modified tibial baseplate locking mechanism, adjusted post height, and increased blend radius at post base. Single-use.

Indications for Use

Indicated for patients with rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, degenerative arthritis, or failed previous knee surgeries (osteotomies, unicompartmental, or total knee replacement) requiring primary or revision surgery where anterior/posterior cruciate ligaments are incompetent but collateral ligaments remain intact.

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 (K042515)

Submission Summary (Full Text)

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Summary of Safety and Effectiveness Revision Journey BCS STD Inserts Smith & Nephew, Inc.

K110837

Date of Summary: March 23, 2011

Contact Person and Address Megan Bevill Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116 T [phone]

APR 2 2 2011

Name of Device: Revision Journey BCS STD Inserts

Common Name: Total Knee Prosthesis

Device Classification Name and Reference: 21 CFR 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis

Device Class: Class II

Panel Code: Orthopaedics/87 JWH

## Device Description

Subject of this premarket notification is a review of changes to the High Performance Knee (previously cleared for market via premarket notification K042515) to result in the Revision Journey BCS STD Inserts. The subject devices are articular inserts manufactured from UHMWPE material. The devices will be available in left and right configurations in sizes 1-2, 3-4, 5-6, and 7-8 and thicknesses from 9-18mm.

When compared to the predicate High Performance Knee, the Revisoin Journey BCS STD Inserts have been modified as follows: -

- I Utilization of a modified articular insert-tibial baseplate locking mechanism
- Post Height Changes I
- Increase in the blend radius at the bottom of the post

#### Intended Use

Total knee components are indicated for:

- 1. Rheumatoid arthritis
- 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
- Failed osteotomies, unicompartmental replacement, or total knee replacement. 3.
- 4. The posterior-stabilized knee system is 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 Revision Journey BCS STD Inserts are indicated for use with bone cement, and are single use devices.

### Performance Data

Design verification testing has been performed based on requirements outlined in FDA's Droft Guidance For the Preparation of Premarket Notifications (510(k)s) For Cemented, Semi-Constrained total Knee Prostheses dated April 1993. A review of the testing has demonstrated that there are no new issues related to the J safety or effectiveness of the subject devices.

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Clinical data was not needed to support the safety and effectiveness of the subject device.

# Substantial Equivalence Information

The Revision Journey BCS STD Inserts are substantially equivalent to previously cleared device listed below . Giving consideration to the device modifications described in the Device Description section, no changes have been made to the overall design philosophy, intended use, and material choices when compared to the predicate knee system.

# Table 1: Predicate knee systems

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|------------------------------------------------------------------------------------------------------|-------------------------------------------------|---------------------------------|
| 1 1499 99 11 | 10000000 | 3/14/05 |

# Conclusion

As previously noted, this Special 510(k) Premarket Notification is being submitted to request clearance for the Revision Journey BCS STD Inserts. Based on the similarities to the predicate device and a review of the testing, the devices are substantially equivalent to knee components currently marketed under K042515.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

Smith & Nephew. Inc. % Ms. Megan Bevill Regulatory Affairs Specialist 1450 Brooks Road Memphis. Tennessee 38116

APR 2 2 2011

Re: K110837

Trade/Device Name: Revision Journey BCS STD Inserts Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: March 23, 2011 Received: March 25, 2011

Dear Ms. Bevill:

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 Part 801); medical device reporting (reporting of medical

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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.

AS. 15. R h
for

Mark N. Melkerso 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): _ K \ \ 0837

Device Name: Revision Journey BCS STD Inserts

Total knee components are indicated for:

- Rheumatoid arthritis 1.
- 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
- కి. Failed osteotomies, unicompartmental replacement, or total knee replacement.
- এ. The posterior-stabilized knee system is 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 BCS STD Inserts are indicated for use without bone cement, and are single use devices.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K. B. R. ha for Nixon

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

510(k) Number k110837