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 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.

AI/ML Overview

This document is a 510(k) summary for a medical device called the "DePuy LPS Distal Femoral Component." It describes the device's intended use, indications for use, and establishes its substantial equivalence to previously cleared predicate devices. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through testing.

Therefore, I cannot provide a detailed response to your request, as the information you are asking for (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, etc.) is not present in the provided text.

This 510(k) submission focuses on demonstrating the new device's substantial equivalence to existing devices based on design, materials, packaging, and sterilization, rather than presenting original clinical or performance study data with specific acceptance criteria.

Summary

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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.700 Orthopaedic DriveWarsaw, Indiana 46582Establishment Registration Number: 1818910
510(K) CONTACT:	Rebecca LennardRegulatory Affairs Associate IITelephone: (574) 372-5023Facsimile: (574) 371-4987Electronic Mail: RLennard@dpyus.jnj.com
ALTERNATE 510(K) CONTACT:	Nancy FriddleTeam Leader, Regulatory AffairsTelephone: (574) 371-4923Facsimile: (574) 371-4987Electronic Mail: NFriddle@dpyus.jnj.com
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 jointpatellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
DEVICE PRODUCT CODE:	87 JWH
SUBSTANTIALLY EQUIVALENTDEVICE:	DePuy LPS, K033959DePuy Orthogenesis LPS System, K003182Noiles Total Knee Prosthesis, K905810

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DEVICE DESCRIPTION:

INTENDED USE AND INDICATIONS FOR USE:

Intended Use:

Indications for Use:

. 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 (240) 276-0120. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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
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Device Name: DePuy LPS Distal Femoral Component

Indications for Use:

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

Page 1 of 1

est ... allye. and Neurological Devices

510(k) Number K043686

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
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).(b)
Classification. Class II.