LEGION POROUS PRIMARY

K073325 · Smith & Nephew, Inc. · MBH · Dec 20, 2007 · Orthopedic

Device Facts

• Record ID: K073325
• Device Name: LEGION POROUS PRIMARY
• Applicant: Smith & Nephew, Inc.
• Product Code: MBH · Orthopedic
• Decision Date: Dec 20, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Total Knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; 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 absent or incompetent and the collateral ligaments remain intact. Smith & Nephew Legion Porous Primary femoral components are indicated for use without bone cement and are single use devices.

Device Story

Legion Porous Primary femoral component; uncemented knee prosthesis; cruciate retaining (C/R) or posterior stabilizing (P/S) designs. Manufactured from Cobalt Chrome alloy; features porous-coated titanium bead layer for bone ingrowth. Available in sizes 1-8; right and left configurations. Used by orthopedic surgeons in clinical settings for total knee arthroplasty. Device provides structural replacement for damaged knee joints; eliminates need for bone cement; promotes biological fixation via porous coating. Benefits include restoration of joint function and mobility in patients with degenerative or inflammatory arthritis.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Material: Cobalt Chrome alloy; porous coating: titanium bead layer conforming to ASTM F67. Design: Cruciate retaining (C/R) and posterior stabilizing (P/S) femoral components. Sizes: 1-8. Application: Uncemented (press-fit).

Indications for Use

Indicated for patients with rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis requiring total knee replacement; suitable for primary and revision surgery where cruciate ligaments are absent/incompetent and collateral ligaments remain intact. Intended for older patients with compatible age, weight, and activity levels. Contraindicated for use with bone cement.

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

• Genesis II Knee System (cemented use)
• Genesis II Knee System (uncemented use)

Submission Summary (Full Text)

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K073325

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# Smith & Nephew, Inc. Summary of Safety and Effectiveness Legion Porous Primary Femoral Component

Date of Summary: 11/19/2007

Contact Person and Address Rishi Sinha Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Reconstruction 1450 Brooks Road Memphis, TN 38116 [phone]

Name of Device: Legion Porous Primary Common Name: Knee Prosthesis

DEC 2 0 2007

## Device Description

Subject of this premarket notification are the Legion Porous Primary femoral components, which are intended for uncemented applications. The Legion Porous Primary femoral components are offered in cruciate retaining (C/R) and posterior stabilizing (P/S) designs, both manufactured from Cobalt Chrome alloy material. The femoral components are available in sizes 1 through 8 in right and left configurations. The femoral components will porous coated using a -45/+60 titanjum bead layer conforming to ASTM F67.

## Device Classification

21 CFR 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis - Class II

### Indications for Use

Total Knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; 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 absent or incompetent and the collateral ligaments remain intact. Smith & Nephew Legion Porous Primary femoral components are indicated for use without bone cement and are single use devices.

### Substantial Equivalence Information

The overall design of the Legion Porous Primary Femoral Component is based on the existing Genesis II Knee System femoral components cleared under the premarket notifications listed below:

| The new to the control of the may be and the comments of the many of the more of the comments of the comments of the comments of the comments of the comments of the comments<br>SUCH PRODUCTION OF DESCRIPTION OF HONOR CONSULTION OF<br>1. BEAT PARTY CLASS PLAN BARRETT PRODUCT OF CLASS OF COLLECTION COLLECTION COLLEGE<br>C REAL TACK THAMPECIAL CARRE, LAND AS BE<br> | 1237 18484452521 1358 11111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111<br>A | was to the loss of the first |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| tenesis II Knee System (cemented lise) | | |
| Genesis II Knee System (uncemented use) | | |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Inc. % Ms. Rishi Sinha Regulatory Affairs Specialist Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116

DEC 2 0 2007

K073325 Re:

> Trade/Device Name: Legion Porous Primary Femoral Component Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH Dated: November 26, 2007 Received: November 27, 2007

Dear Ms. Sinha:

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 such 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); 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.

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Page 2 - Ms. Rishi Sinha

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological 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 Primary Femoral Component

Indications for Use:

Total Knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; 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 absent or incompetent and the collateral ligaments remain intact. Smith & Nephew Legion Porous Primary femoral components are indicated for use without bone cement and are single use devices.

Prescription Use (Part 21 CFR 801 Subpart D)

×

AND/OR

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)

Darbarc Buchup

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Division of General, Restorative. and Neurological Devices

**510(k) Number** k073325