Not Found
No
The summary describes a modular prosthetic system for bone replacement and does not mention any AI/ML capabilities or related data/performance metrics.
No
The device is described as an orthopedic implant for replacement of bone, not for therapy.
No
The device description clearly states "The LPS components are designed for the replacement of the mid-shaft portion of the femur..." and the intended use lists conditions requiring "extensive resection and replacement," indicating it is a prosthetic device for treatment, not diagnosis. The "diagnostic indications for use" section refers to the conditions for which the device is used, not that the device itself performs diagnosis.
No
The device description clearly indicates it is a system of physical components (implants) for bone replacement, 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 for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this device is a prosthesis intended for the replacement of bone portions (femur and tibia) in cases requiring extensive resection. It is a surgical implant used directly within the body.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens or providing diagnostic information based on such analysis. Its function is structural replacement.
Therefore, this device falls under the category of a surgical implant or prosthesis, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The 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 distal femoral component, the tibial components, 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, 87 JDI
Device Description
The LPS components are designed for the replacement of the mid-shaft portion of the femur. proximal, distal and/or total femur, and proximal 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 femoral replacement is possible in those cases where no part of the femur can be salvaged.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia
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)
The determination of substantial equivalence for this device was based on a detailed device description and conformance with voluntary performance standards.
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
K033959 (pg 1 of.
510(k) Summary LPS
DePuy, Inc. 700 Orthopaedic Drive Warsaw, IN 46581
JUL 0 1 2004
A. Contact Person: Dina L. Weissman, J.D. Legal Consultant, Regulatory Affairs TEL: (574) 371-4905, FAX (574) 371-4987, EMAIL dweissma@dpyus.jnj.com
B. Device Information:
| Proprietary Name: | LPS |
|---|---|
| Common Name: | Total Knee Prosthesis |
| Femoral Stem Prosthesis | |
| Classification Name | |
| and Regulatory Class: | Knee joint patellofemorotibial polymer/metal/polymer |
| semi-constrained cemented prosthesis: Class II per | |
| 21 CFR §888.3560 | |
| Hip joint metal/polymer semi-constrained cemented | |
| prosthesis: Class II per 21 CFR §888.3350 | |
| Product Code: | 87 JWH, 87 JDI |
C. Indications for Use (changes are in bold from those cleared in K003182):
The 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 distal femoral component, the tibial components, and the non-porous coated straight and bowed stems are intended for cemented use only.
1
K033959 (fig 2 of 2)
510(k) Summary (continued)
LPS
D. Device Description (unchanged from that cleared in K003182):
The LPS components are designed for the replacement of the mid-shaft portion of the femur. proximal, distal and/or total femur, and proximal 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 femoral replacement is possible in those cases where no part of the femur can be salvaged.
E. Substantial Equivalence (same device as that cleared in K003182, only the material has changed to cobalt chrome):
The substantial equivalence of the LPS is substantiated by its similarity:
- . in design, sterilization and packaging to the LPS (K003182 cleared on June 27, 2001).
- . in materials to the S-ROM Noiles Rotating Hinge Knee (K870730 cleared on May 26, 1987).
- . in indications for use to the Howmedica Global Modular Replacement System (GMRS) (K023087 cleared on December 16, 2002).
The determination of substantial equivalence for this device was based on a detailed device description and conformance with voluntary performance standards.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines that form the shape of a person's head and torso.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 01 2004
Ms. Dina L. Weissman, J.D. Legal Consultant, Regulatory Affairs DePuy, Inc. 700 Orthopaedic Drive Warsaw. Indiana 46581
Re: K033959
Trade/Device Name: LPS Regulation Number: 21 CFR 888.3560, 21 CFR 888.3350 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Hip joint metal/polymer semi-constrained cemented prosthesis
Regulatory Class: II Product Code: JWH, JDI Dated: April 20, 2004 Received: April 21, 2004
Dear Ms. Weissman:
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 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.
3
Page 2 - Ms. Dina L. Weissman, J.D.
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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam. C. Provost
for
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
4
Indications for Use
510(k) Number (if known): K033959 rbs Device Name:
Indications for Use: (changes from those cleared in K003182 are in bold)
ions for Use: (Changes from those crearce in 1500 roid-shaft portion of the femur.
The LPS is intended for use in replacement of the mid-shaft on eases that The LPS is intended for use in replacement cimal tibia, especially in cases that
proximal, distal and/or total femur, and proximal andications a proximal, distal and of total lemar, and promise with diagnostic indications for use include:
- malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, . malignant tumors (e.g.), tensive resection and replacement;
- bone tunnols) requiring extensive its station in the soint disease (NIDJD), . patient conditions of nominflammatory adgenerals is in the placement e.g., avascular necrosis; osteour.in Mo, testensive resection and replacement;
- e.g., theumalord artifitis, requiring careering extensive resection . and replacement;
- and replacement,
severe trauma requiring extensive resection and replacement. .
The LPS is also intended for use in bone loss post-infection, where the I he LT S is also intended for the bone and replacement is required.
The distal femoral component, the tibial components, and the non-porous coated I ne distan temoral comps are intended for cemented use only.
| 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of 1
(Posted November) 9,000)Jumber________________________________________________________________________________________________________________________________________________