LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTS

K112941 · Smith & Nephew, Inc. · JWH · Dec 20, 2011 · Orthopedic

Device Facts

• Record ID: K112941
• Device Name: LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTS
• Applicant: Smith & Nephew, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Dec 20, 2011
• 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. Posterior stabilized knee systems are 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. Smith & Nephew, Inc. Legion Narrow Oxinium CR and PS Femoral Components are indicated for single use only and for use only with bone cement.

Device Story

Legion Narrow Oxinium CR and PS Femoral Components are orthopedic implants for total knee replacement. Manufactured from oxidized zirconium alloy (Oxinium). Designed for primary or revision surgery to restore joint function in patients with arthritis or failed prior knee procedures. Implants are used by orthopedic surgeons in a clinical/hospital setting. The device replaces the femoral surface of the knee joint, articulating with a polyethylene insert and metal tibial base. The surgeon selects the appropriate size and configuration (CR or PS) based on patient anatomy and ligamentous stability. The device is fixed using bone cement. Benefits include restoration of knee joint mechanics and reduction of pain associated with degenerative or inflammatory joint disease.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including tibiofemoral constraint testing (A/P draw, M/L shear, and rotary laxity), tibiofemoral contact area testing, and patellofemoral subluxation resistance testing compared to predicate devices.

Technological Characteristics

Implantable femoral components manufactured from oxidized zirconium alloy (Oxinium). Designed as semi-constrained, cemented, patellofemoral-tibial prostheses. Available in multiple sizes and configurations (CR and PS). Mechanical design features include specific geometry for narrow anatomy. No software or electronic components.

Indications for Use

Indicated for patients requiring primary or revision total knee arthroplasty due to rheumatoid, post-traumatic, or degenerative arthritis, or failed previous procedures (osteotomy, unicompartmental, or total knee replacement). Posterior stabilized systems indicated when anterior/posterior cruciate ligaments are incompetent and collateral ligaments are intact. For single use only; must be used with bone cement.

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 Total Knee System (K951987)
• Genesis II and Profix Zirconium Femoral Components (K962557)
• Legion Primary Knee System (K093746)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness Legion Narrow Oxinium CR and PS Femoral Components and Device Specific Instruments

| Submitted By: | Smith & Nephew, Inc.<br>Orthopaedics<br>1450 Brooks Road<br>Memphis, TN 38116 |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Date: | October 3, 2011 |
| Contact Person: | David Henley, Regulatory Affairs Project Manager<br>Tel: [phone] Fax: [phone] |
| Proprietary Name: | Legion Narrow Oxinium CR and PS Femoral<br>Components and Instruments |
| Common Name: | Total Knee Prosthesis |
| Classification Name and Reference: | 21 CFR 888.3560, Knee joint patellofemorotibial<br>polymer/metal/polymer semi-constrained cemented<br>prosthesis |
| Device Class | Class II |
| Device Product Code and Panel Code: | JWH / Orthopedics / 87 |

### Device Description:

The implant devices described in this premarket notification are comprised of Legion Narrow Oxinium Cruciate Retaining (CR) and Posterior Stabilized (PS) Femoral Components. All described implant components are manufactured from oxidized zirconium alloy material (trade name: Oxinium). The subject devices are available in the following configurations and sizes:

| Device Type | Hand | Available Sizes |
|---------------------------------------------|-------|-----------------|
| Legion Narrow Oxinium CR Femoral Components | Left | 3, 4, 5 and 6 |
| Legion Narrow Oxinium CR Femoral Components | Right | 3, 4, 5 and 6 |
| Legion Narrow Oxinium PS Femoral Components | Left | 3, 4, 5 and 6 |
| Legion Narrow Oxinium PS Femoral Components | Right | 3, 4, 5 and 6 |

Device specific instruments are also described in this premarket notification in select sections and exhibits.

#### Intended Use:

Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, or degenerative arthritis; 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 incompetent and the collateral ligaments remain intact.

Smith & Nephew, Inc. Legion Narrow Oxinium CR and PS Femoral Components are indicated for single use only and for use only with bone cement.

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#### Technological Characteristics:

Components comprising Legion Narrow Oxinium CR and PS Femoral Components are verv similar to the legally marketed devices listed below. When compared to the predicates, the proposed devices share very similar or identical Indications for Use, intended use, are manufactured from similar or identical materials, and incorporate very similar technological design characteristics.

#### Substantial Equivalence Information:

When compared to the implant and device specific instrument predicate devices listed below. substantial equivalence is based on similarities with regard to overall indications for use, material composition, and technological design characteristics.

- · Genesis II Total Knee System K951987
- · Genesis II and Profix Zirconium Femoral Components K962557
- · Legion Primary Knee System K093746

### Preclinical Testing:

To further support a determination of substantial equivalence, various types of pre-clinical testing were conducted on the subject, implantable devices in comparison against one or more of the previously cleared predicate devices described above. The specific types of pre-clinical testing included:

- · Tibiofemoral Constraint Testing of femorals against interfacing polyethylene articular insert components seated in appropriate metal tibial bases in A/P Draw, M/L Shear and rotary laxity (R/L)
- · Tibiofemoral Contact Area Testing of femorals against interfacing polyethylene articular insert components seated in appropriate metal tibial bases
- Patellofemoral Subluxation Testing of the femoral to determine the amount of resistance to lateral subluxation of the patellofemoral interface

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

DEC 2 0 2011

Smith & Nephew, Inc. Orthopaedics Division % Mr. David Henley Regulatory Affairs Project Manager 7135 Goodlet Farms Parkway Cordova, Tennessee 38016

Re: K112941

Trade/Device Name: Legion Narrow Oxinium Cruciate Retaining (CR) and Posterior Stabilized (PS) Femoral Components and Device Specific Instruments 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: October 3, 2011 Received: October 4, 2011

Dear Mr. Henley:

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.

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#### Page 2 - Mr. David Henley

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 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.

Erine Keith

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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## Premarket Notification

# Indications for Use Statement

510(k) Number (if known): _ K || 29 H |

Device Name: Legion Narrow Oxinium C/R and P/S Femoral Components

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. Posterior stabilized knee systems are 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.

Smith & Nephew, Inc. Legion Narrow Oxinium C/R and P/S Femoral Components are indicated for use only with cement and are single use only devices.

x Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (Part 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)

for Mark Melkerson

(Division Sign-Off) (Division Sign-On), Orthopedic, Division of Restorative Devices

K112941

510(k) Number .