LEGION POROUS + HA TIBIAL BASEPLATES

K100897 · Smith & Nephew, Inc. · MBH · May 13, 2010 · Orthopedic

Device Facts

• Record ID: K100897
• Device Name: LEGION POROUS + HA TIBIAL BASEPLATES
• Applicant: Smith & Nephew, Inc.
• Product Code: MBH · Orthopedic
• Decision Date: May 13, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3565
• 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 in older patients whose age, weight, and activity levels are compatible with an adequate long-term result. 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 Legion Porous + HA Tibial Baseplates are indicated for use without bone cement, and are single use devices.

Device Story

Legion Porous + HA Tibial Baseplate is an uncemented orthopedic implant for total knee arthroplasty. Device serves as a tibial component in primary or revision knee replacement. Manufactured from Ti-6Al-4V alloy; features porous coating of CP Ti beads and hydroxyapatite (HA) coating for bone integration. Modified from Profix Porous Tibial Baseplates (K030623) by incorporating Genesis II style periphery, profile, and locking detail, plus increased baseplate thickness. Implanted by orthopedic surgeons in clinical/OR settings. Provides mechanical stability for knee joint reconstruction; intended to restore joint function and alleviate pain in patients with degenerative or inflammatory joint disease. Single-use device.

Clinical Evidence

Bench testing only. No clinical data required or provided to support safety and effectiveness. Verification testing performed per FDA Class 2 Special Controls Guidance Document for Knee Joint Patellofemoratibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses.

Technological Characteristics

Material: Ti-6Al-4V alloy. Surface: Porous coating of CP Ti beads with HA coating. Configuration: Left and right, sizes 2-8. Design: Genesis II style periphery, profile, and locking detail. Uncemented fixation. Single-use. No software or electronic components.

Indications for Use

Indicated for patients with rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis requiring primary or revision knee surgery, specifically those with incompetent anterior/posterior cruciate ligaments and intact collateral ligaments. Suitable for older patients with compatible age, weight, and activity levels.

Regulatory Classification

Identification

A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.

Predicate Devices

• Profix Total Knee System (K030623)
• Genesis II Porous + HA Knee System (K032683)

Submission Summary (Full Text)

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K(∞89 7

Summary of Safety and Effectiveness LEGION Porous + HA Tibial Baseplates Smith & Nephew, Inc.

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

Date of Summary: April 14, 2010

MAY 1 3 2010

Name of Device: Legion Porous + HA Tibial Baseplate Common Name: Total Knee Prosthesis Device Classification Name and Reference: 21 CFR 888.3565 Knee joint patellofemorotibial metal/polymer porous coated uncemented prosthesis Device Class: Class II Panel Code: Orthopaedics/87 MBH

#### Device Description

Subject of this premarket notification is a review of changes to the Profix Porous Tibial Baseplates (previously cleared for market via premarket notification K030623) to result in the Legion Porous + HA Tibial Baseplates. The subject devices are uncemented tibial baseplates manufactured from Ti-6Al-4V material and feature a porous coating of CP Ti beads and an HA coating. The devices will be available in left and right configurations in sizes 2 through 8.

When compared to the predicate Profix Porous Tibial Baseplates, the Legion Porous + HA Tibial Baseplates have been modified as follows:

- 0 Utilization of the Genesis II style periphery, profile, and locking detail
- . Addition of HA coating
- 트 Increase in thickness of baseplate

#### Intended Use

Total knee components are indicated for:

- 1. Rheumatoid arthritis
- 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.
- 3. 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 Legion Porous + HA Tibial Baseplates are indicated for use without bone cement, and are single use devices.

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# Summary of Safety and Effectiveness LEGION Porous + HA Tibial Baseplates Smith & Nephew, Inc.

## Performance Data

Design verification testing has been performed based on requirements outlined in FDA's Class 2 Special Controls Guidance Document Knee Joint Patellofemoratibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and Staff, dated January 16, 2003 and Draft Guidance Document for Testing Non-Articulating, "Mechanically Locked", Modular Implant Components dated May 1, 1995. A review of the testing has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices.

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

# Substantial Equivalence Information

The Legion Porous + HA Tibial Baseplates are substantially equivalent to previously cleared devices 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 systems.

| Description | 510(k) | Clearance Date |
|------------------------------------|---------|----------------|
| Profix Total Knee System | K030623 | 5/22/03 |
| Genesis II Porous + HA Knee System | K032683 | 10/15/03 |

#### Table 1. Predicate knee systems

### Conclusion

As previously noted, this Special 510(k) Premarket Notification is being submitted to request clearance for the Legion Porous + HA Tibial Baseplates. Based on the similarities to the predicate devices and a review of the testing, the devices are substantially equivalent to knee components currently marketed under K030623 and K032683.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.

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

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

MAY 1 3 2010

Re: K100897

Trade/Device Name: Legion Porous + HA Tibial Baseplates Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous coated uncemented prosthesis Regulatory Class: II Product Code: MBH Dated: April 14, 2010 Received: April 15, 2010

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

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## Page 2 - Ms. Megan Bevill

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,

Barbara Buechner

Mark N. Melke 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: Legion Porous + HA Tibial Baseplate

Total knee components are indicated for:

- ﺒﺴﺘ Rheumatoid arthritis
- 2. Post-traumatic arthrilis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
- 3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
- The posterior-stabilized knee system is designed for use in patients in primary and revision 4. surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

The Legion Porous + HA Tibial Baseplates 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 Cl

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Omitted for nxm
(Claim Signed)

Division of Surgical and Restorative Devices

510(k) Number K100897