ORTHOGENESIS LPS SYSTEM

K003182 · Depuy, Inc. · JWH · Jun 27, 2001 · Orthopedic

Device Facts

• Record ID: K003182
• Device Name: ORTHOGENESIS LPS SYSTEM
• Applicant: Depuy, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Jun 27, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Orthogenesis LPS System is intended for use in replacement of the mid-shaft or intercalary portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and restoration. Specific diagnostic indications for use include: - metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur; - 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 of the proximal and/or distal femur; - patients suffering from severe arthropathy of the hip and/or knee that does not respond to any conservative therapy or better alternative surgical treatment; - revision cases requiring extensive resection(s) and replacements of the proximal, distal or total femur or proximal tibia. The distal femoral and tibial components, tibial stems and non-porous coated femoral stems are intended for cemented use only.

Device Story

Orthogenesis LPS System; modular orthopedic prosthesis for extensive bone resection and reconstruction. Used for total/partial femur and proximal tibia replacement in oncology or end-stage revision cases. Implanted by orthopedic surgeons in surgical settings. Provides structural skeletal support; restores joint function. Distal femoral/tibial components and specific stems require bone cement for fixation. System design facilitates restoration where native bone cannot be salvaged.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and performance standards.

Technological Characteristics

Modular orthopedic prosthesis; metal/polymer construction. Components include femoral and tibial segments. Distal femoral and tibial components, tibial stems, and non-porous coated femoral stems designed for cemented fixation. Sterilization and packaging methods consistent with predicate devices.

Indications for Use

Indicated for patients requiring extensive resection and restoration of the femur (mid-shaft, intercalary, proximal, distal, or total) or proximal tibia due to metastatic bone disease, noninflammatory degenerative joint disease (e.g., avascular necrosis, osteoarthritis), inflammatory joint disease (e.g., rheumatoid arthritis), severe hip/knee arthropathy unresponsive to conservative therapy, or revision surgery.

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

• S-ROM Noiles (K896048, K905810, K924940)
• Sulzer Orthopedics MOST System (K973087)
• Wright Medical Segmented Orthopaedic System (SOS) (K933281)
• Howemedica MRS (K972401, K965164)

Submission Summary (Full Text)

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# ( 003182

# JUN 2 7 2001

## 510(k) Summary Orthogenesis LPS System

DePuy, Inc. 700 Orthopaedic Drive Warsaw, IN 46581

#### A. Contact Person:

Janet G. Johnson, RAC Group Leader, Regulatory Submissions [phone]

#### B. Device Information:

| Proprietary Name: | Orthogenesis LPS System |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Total Femur Replacement Prosthesis<br>Proximal Tibial Replacement Prosthesis |
| Classification Name and<br>Regulatory Class: | Knee joint patellofemorotibial polymer/metal/polymer<br>semi-constrained cemented prosthesis: Class II per 21<br>CFR §888.3560<br>Hip joint metal/polymer semi-constrained cemented<br>prosthesis: Class II per 21 CFR §888.3350<br>Hip joint metal/polymer/metal semi-constrained<br>porous coated uncemented prosthesis: Class II per 21<br>CFR §888.3358 |
| Product Code: | 87 JWH, 87 JDI, 87 LPH |

#### C. Indications for Use:

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

- metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone . tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur:
- 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 of the proximal and/or distal femur;
- patients suffering from severe arthropathy of the hip and/or knee that does not . respond to any conservative therapy or better alternative surgical treatment;
- revision cases requiring extensive resection(s) and replacements of the proximal, . distal or total femur or proximal tibia.

The distal femoral and tibial components, tibial stems and non-porous coated femoral stems are intended for cemented use only.

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#### D. Device Description:

The Orthogenesis LPS components are designed to be implanted for the replacement of the mid-shaft or intercalary portion of the femur, proximal, distal and/or total femur, and mroximal tibia. Unlike primary hip and knee systems, this system is used when the amount of resection and restoration is extreme (e.g. in oncology cases, endstage revision). A total of roovenon and renoration in those cases where no part of the femur can be salvaged.

KOO 3187

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### E. Substantial Equivalence:

The substantial equivalence of the Orthogenesis LPS System is substantiated by its similarity in indications for use, design, materials, sterilization and packaging to the S-ROM Noiles In marea. Ion and Tor assess of 30, K896048, K905810 and K924940), the Sulzer Orthopedics MOST™ System (K973087), Wright Medical Segmented Orthopaedic System (SOS) (K933281) and the Howemedica MRS (K972401 and K965164).

The determination of substantial equivalence for this device was based on a detailed device I he withinmance or esting and conformance with voluntary performance standards.

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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 eagle with three heads, representing the department's mission to protect the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 7 2001

Ms. Janet G. Johnson Group Leader, Regulatory Submissions DePuv Orthopaedics, Inc. P.O. Box 988 700 Orthopedic Drive Warsaw. Indiana 46581

Re: K003182

Trade Name: Orthogenesis LPS System Regulatory Number: 888.3560 and 888.3350 Regulatory Class: II Product Code: JWH and JDI Dated: May 3, 2001 Received: May 4, 2001

#### Dear Ms. Johnson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Ms. Janet G. Johnson

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Memhleeeto fo)

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) Device Name

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### Orthogenesis LPS System

### Indications for Use

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

- metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone . tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur;
- 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 of the proximal and/or distal femur;
- patients suffering from severe arthropathy of the hip and/or knee that does not . respond to any conservative therapy or better alternative surgical treatment;
- revision cases requiring extensive resection(s) and replacements of the proximal, . distal or total femur or proximal tibia.

The distal femoral and tibial components, tibial stems and non-porous coated femoral stems are intended for cemented use only.

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

Bmitchelling for chu

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K003182

Prescription Use (Per 21 CFR §801.109)

OR

Over-the-Counter Use

(Optional Format 1-2-96)

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