DEPUY LPS DISTAL FEMORAL COMPONENT

K063686 · DePuy Orthopaedics, Inc. · JWH · Dec 20, 2007 · Orthopedic

Device Facts

• Record ID: K063686
• Device Name: DEPUY LPS DISTAL FEMORAL COMPONENT
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Dec 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy LPS is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include: - malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement; - patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement; - revision cases for a failed previous prosthesis requiring extensive resection and replacement; - severe trauma requiring extensive resection and replacement. The LPS is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required. The S-ROM tibial tray and the non-porous coated straight and bowed stems are intended for cemented use only.

Device Story

Modular distal femoral component; replaces distal femur in oncology or end-stage revision cases requiring extensive bone resection. Manufactured from cobalt-chrome-molybdenum alloy; features highly polished mirror finish for articulation with polyethylene tibial plateau/hinge assembly and resurfaced patella. Available in two sizes (X-small low profile, XX-small) in left/right configurations. Used by orthopedic surgeons in clinical/surgical settings. Provides structural replacement for bone loss; restores joint function; enables mobility in patients with severe bone pathology.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Cobalt-chrome-molybdenum alloy construction; modular design; mirror-polished articulating surface. Designed for use with polyethylene tibial/patellar components. Cemented fixation for specific components (S-ROM tibial tray, non-porous stems).

Indications for Use

Indicated for patients requiring extensive resection and replacement of the femur (mid-shaft, proximal, distal, or total) or proximal tibia due to malignant tumors, noninflammatory degenerative joint disease (e.g., avascular necrosis, osteoarthritis), inflammatory joint disease (e.g., rheumatoid arthritis), failed previous prosthesis, severe trauma, or bone loss post-infection.

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

• DePuy LPS (K033959)
• DePuy Orthogenesis LPS System (K003182)
• Noiles Total Knee Prosthesis (K905810)

Submission Summary (Full Text)

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K063686

# Section 5 – 510 (k) Summary

(As required by 21 CFR 807.92(c) and 21 CFR 807.93)

DEC 2 0 2007

| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46582<br>Establishment Registration Number: 1818910 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Rebecca Lennard<br>Regulatory Affairs Associate II<br>Telephone: [phone]<br>Facsimile: [phone]<br>Electronic Mail: [e-mail] |
| ALTERNATE 510(K) CONTACT: | Nancy Friddle<br>Team Leader, Regulatory Affairs<br>Telephone: [phone]<br>Facsimile: [phone]<br>Electronic Mail: [e-mail] |
| DATE PREPARED: | September 14, 2006 |
| PROPRIETARY NAME: | DePuy LPS Distal Femoral Component |
| COMMON NAME: | Distal Femoral Component |
| CLASSIFICATION: | Class II Device per 21 CFR 888.3560: Knee joint<br>patellofemorotibial polymer/metal/polymer semi-<br>constrained cemented prosthesis |
| DEVICE PRODUCT CODE: | 87 JWH |
| SUBSTANTIALLY EQUIVALENT<br>DEVICE: | DePuy LPS, K033959<br>DePuy Orthogenesis LPS System, K003182<br>Noiles Total Knee Prosthesis, K905810 |

:

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## DEVICE DESCRIPTION:

The subject DePuy LPS Distal Femoral Component is a modular component that is designed to replace the distal portion of the femur. Unlike primary knee systems, the LPS System is used when the amount of bone resection and replacement is extreme (e.g. in oncology cases or endstage revision).

The LPS Distal Femoral Component is manufactured from cobalt-chromemolybdenum alloy and is available in two sizes, X-small low profile and XX-small, both in left and right configurations. The surface has a highly polished mirror finish for smooth articulation with the polyethylene component of the tibial plateau/hinge assembly and the resurfaced patella.

#### INTENDED USE AND INDICATIONS FOR USE:

#### Intended Use:

The DePuy LPS is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement.

#### Indications for Use:

The DePuy LPS is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:

- . malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement;
- patient conditions of noninflammatory degenerative joint disease (NIDJD), . e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD). e.g., rheumatoid arthritis, requiring extensive resection and replacement;
- revision cases for a failed previous prosthesis requiring extensive resection . and replacement;
- severe trauma requiring extensive resection and replacement. .

The LPS is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.

The S-ROM tibial tray and the non-porous coated straight and bowed stems are intended for cemented use only.

## BASIS OF SUBSTANTIAL EQUIVALENCE:

The substantial equivalence of the LPS Distal Femoral Component is substantiated by its similarity:

- = in indications for use to the DePuy LPS (K033959 cleared on July 1, 2004)

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- in design, materials, packaging and sterilization to the Orthogenesis LPS י Distal Femoral Replacement System (K003182 cleared on June 27, 2001) and the Noiles Total Knee Prosthesis femoral component (K905810 cleared on June 12, 1991).

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized emblem featuring an abstract representation of a human figure or symbol, composed of three curved lines or strokes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2007

DePuv Orthopaedics, Inc. % Nancy S. Friddle Project Manager, Regulatory 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K063686

Trade/Device Name: DePuy LPS Distal Femoral Component Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: September 25, 2007 Received: September 26, 2007

Dear Ms. Friddle:

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. Iisting 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. Nancy S. Friddle

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 at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Martin H. 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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# Section 4 - Indications for Use Statement

| 510 (k) Number (if known): | K063686 |
|----------------------------|---------|
|----------------------------|---------|

Device Name: DePuy LPS Distal Femoral Component

#### Indications for Use:

The DePuy LPS is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:

- malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, . bone tumors) requiring extensive resection and replacement;
- patient conditions of noninflammatory degenerative joint disease (NIDJD), . e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement:
- revision cases for a failed previous prosthesis requiring extensive resection . and replacement;
- . severe trauma requiring extensive resection and replacement.

The LPS is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.

The S-ROM tibial tray and the non-porous coated straight and bowed stems are intended for cemented use only.

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

(Posted November 13, 2003)

Clarbare Bonem

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est ... allye. and Neurological Devices

510(k) Number K043686

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