DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES

K071417 · DePuy Orthopaedics, Inc. · MBH · Aug 2, 2007 · Orthopedic

Device Facts

• Record ID: K071417
• Device Name: DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: MBH · Orthopedic
• Decision Date: Aug 2, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy LPS Diaphyseal and Metaphyseal Sleeves are intended for use in primary and revision knee joint replacement in the treatment of patients presenting bone loss and deformity associated with bone tumors resection, trauma, infection, and difficult revision arthroplasty. The diaphyseal sleeve is intended to enhance the fit and fill of the diaphyseal femoral canal with distal femoral, proximal femoral, and proximal tibial replacements. The metaphyseal sleeve is intended to enhance the fit and fill of the metaphyseal region of the distal femur with femoral replacements. 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. The diaphyseal and metaphyseal sleeves are intended for either cemented or cementless applications.

Device Story

Modular, porous-coated, cone-shaped (diaphyseal) and flared (metaphyseal) orthopedic components; manufactured from titanium alloy. Designed to enhance fit and fill of femoral/tibial canals during primary or revision knee joint replacement. Used by orthopedic surgeons in clinical settings. Sleeves support cemented or cementless fixation. Provides structural augmentation for bone loss associated with tumors, trauma, or failed implants; improves prosthetic stability and patient outcomes in complex reconstructive surgeries.

Clinical Evidence

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

Technological Characteristics

Modular components; titanium alloy construction; porous-coated surface for biological fixation; cone-shaped (diaphyseal) and flared (metaphyseal) geometries; compatible with cemented or cementless application.

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 bone 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 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

• DePuy Orthogenesis LPS System (K003182)
• DePuy LPS Metaphyseal Sleeve (K040281)
• DePuy Stability Hip Stem with Porocoat® (K934457)

Submission Summary (Full Text)

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KO71417 Pose Is

AUG - 2 2007

## 510 (k) Summary

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

| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46582<br>Establishment Registration Number: 1818910 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Rhonda Myer<br>Regulatory Affairs<br>Telephone: [phone]<br>Facsimile: [phone]<br>Electronic Mail: [e-mail] |
| DATE PREPARED: | May 16, 2007 |
| PROPRIETARY NAME: | LPS Diaphyseal and Metaphyseal Sleeves |
| COMMON NAME: | Diaphyseal and Metaphyseal Sleeve Components |
| CLASSIFICATION: | 888.3565 Knee joint patellofemorotibial<br>metal/polymer porous-coated uncemented<br>prosthesis<br>888.3560 Knee joint patellofemorotibial<br>polymer/metal/polymer semi-constrained<br>cemented prosthesis |
| DEVICE PRODUCT CODE: | 87 MBH, JWH |
| SUBSTANTIALLY EQUIVALENT<br>DEVICES: | DePuy Orthogenesis LPS System, K003182<br>DePuy LPS Metaphyseal Sleeve, K040281<br>DePuy Stability Hip Stem with Porocoat®,<br>K934457 |

### DEVICE DESCRIPTION:

The DePuy LPS Diaphyseal Sleeve is a modular, porous-coated, cone-shaped component designed to enhance the fit and fill of the diaphyseal femoral canal with distal femoral, proximal femoral and proximal tibial replacements. The existing LPS Metaphyseal Sleeve (K040281) is a modular, porous-coated, flared component designed for enhanced fit and fill of the metaphyseal region of the distal femur with femoral replacements. Both are manufactured from titanium alloy.

# INTENDED USE AND INDICATIONS:

#### Intended Use:

The DePuy LPS Diaphyseal and Metaphyseal Sleeves are intended for use in primary and revision knee joint replacement in the treatment of patients presenting bone loss and deformity associated with bone tumors resection, trauma, infection, and difficult revision arthroplasty.

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# Indications for Use:

The diaphyseal sleeve is intended to enhance the fit and fill of the diaphyseal femoral canal with distal femoral, proximal femoral, and proximal tibial replacements. The metaphyseal sleeve is intended to enhance the fit and fill of the metaphyseal region of the distal femur with femoral replacements.

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.

The diaphyseal and metaphyseal sleeves are intended for either cemented or cementless applications.

# BASIS OF SUBSTANTIAL EQUIVALENCE:

The substantial equivalence of the DePuy LPS Diaphyseal and Metaphyseal Sleeves is shown by the similarity in intended use, indications for use, materials and design to the existing DePuy Orthogenesis LPS, K003182 cleared on June 27, 2001, DePuy LPS Metaphyseal Sleeves, K040281 cleared on July 09, 2004, and DePuy Stability Hip Stem with Porocoat®, K934457.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profile graphic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics, Inc. % Ms. Rhonda Myer Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46582

AUG - 2 2007

Re: K071417

> Trade/Device Name: LPS Diaphyseal and Metaphyseal Sleeves Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: July 24, 2007 Received: July 25, 2007

Dear Ms. Myer:

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

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## Page 2 - Ms. Rhonda Myer

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. 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely vours.

Mark A. Milliken

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 Statement

510 (k) Number (if known): K071417

Device Name: LPS Diaphyseal and Metaphyseal Sleeves

#### Indications for Use:

The diaphyseal sleeve is intended to enhance the fit and fill of the diaphyseal femoral canal with distal femoral, proximal femoral, and proximal tibial replacements. The metaphyseal sleeve is intended to enhance the fit and fill of the metaphyseal region of the distal femur with femoral replacements.

The DePuy LPS is intended for use in replacement of the mid-shaft portion of the femur, The Dot af Er B is to it it to the 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. . pations benefitions of teoarthritis, 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.

The porous-coated diaphyseal and metaphyseal sleeves are intended for either cemented or cementless applications.

Prescription Use X (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.)

Page 6 of 61
DePuy LPS Additional Information (K071417)
Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div> <i>Mark A. Mellerson</i> </div> | Page 1 of 1 |
|---------------|------------------------------------------------------------|-------------|
| | (Division Sign-Off) | |
| | Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K071417 | 5 |