(373 days)
Not Found
No
The document describes a mechanical orthopedic implant (a modular femoral component) and its intended use in surgical procedures. There is no mention of software, algorithms, data processing, or any terms related to AI or ML. The focus is on the material, design, and surgical application of the physical device.
Yes
The device is a prosthesis designed to replace resected portions of bone, used to treat conditions like malignant tumors, degenerative joint disease, and severe trauma, thereby providing therapeutic benefit by restoring function and alleviating symptoms.
No
Explanation: The provided text describes the DePuy LPS as a prosthetic device intended for the replacement of portions of the femur and tibia. It lists "Specific diagnostic indications for use" which refer to the medical conditions that necessitate the replacement, not that the device itself performs diagnostic functions. The device description also focuses on its physical characteristics and purpose as a replacement component. It does not mention any diagnostic capabilities.
No
The device description clearly states it is a modular component manufactured from cobalt-chromemolybdenum alloy, indicating it is a physical implant, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The DePuy LPS is described as a modular component designed to replace portions of the femur and tibia. It is a physical implant used in surgical procedures.
- Intended Use: The intended use clearly states it's for the "replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia." This is a surgical intervention, not a diagnostic test performed on a specimen.
The device is a surgical implant used for treatment, not for diagnosing a condition by analyzing samples outside the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
87 JWH, JWH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, tibia, knee joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Drive
Warsaw, Indiana 46582
Establishment Registration Number: 1818910 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Rebecca Lennard
Regulatory Affairs Associate II
Telephone: (574) 372-5023
Facsimile: (574) 371-4987
Electronic Mail: RLennard@dpyus.jnj.com |
| ALTERNATE 510(K) CONTACT: | Nancy Friddle
Team Leader, Regulatory Affairs
Telephone: (574) 371-4923
Facsimile: (574) 371-4987
Electronic 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 joint
patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis |
| DEVICE PRODUCT CODE: | 87 JWH |
| SUBSTANTIALLY EQUIVALENT
DEVICE: | DePuy LPS, K033959
DePuy Orthogenesis LPS System, K003182
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).
3
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 |
|---|---|
| ---------------------------- | --------- |
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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