(87 days)
Not Found
No
The document describes a mechanical implant component and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is an implantable component of a limb preservation system used for replacing bone sections in cases like malignant tumors, degenerative joint disease, and severe trauma, all of which fall under therapeutic applications to treat these conditions.
No
Explanation: The device is an implantable component for knee joint replacement, specifically for use in primary and revision knee joint replacement and oncology cases. Its purpose is to replace bone, not to diagnose a condition.
No
The device description clearly states it is a physical component made of cobalt chrome, intended for surgical implantation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the LPS Intercalary component is a physical implant used in surgical procedures for knee joint replacement and oncology cases. It is a component of a larger system designed to replace bone segments.
- Lack of Mention of Biological Samples or Testing: There is no mention of the device interacting with or analyzing biological samples. Its function is mechanical replacement of bone.
Therefore, the 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 Intercalary component is intended for use in primary and revision knee joint replacement and in oncology cases with the Limb Preservation System (LPS). The previously cleared indications for use for this systems are the following:
The Limb Preservation System (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., osteosarcoma, chondrosarcoma, 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, tibial stems, metaphyseal sleeves, 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
Device Description
The intercalary component serves as a segmental component in the previously cleared Limb Preservation System (LPS, K003182). The dovetail intercalary component is a 3piece assembly 55 mm in length. The three pieces are comprised of a male segment, a female segment and a connecting pin. The male-female parts connect as a dovetail connection and locked with a pin screwed through both segments. The dovetail intercalary component is made of cobalt chrome.
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)
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
page 1 of 2
510(k) Summary LPS_Dovetail Intercalary
04/085
A. Contact Person:
Tiffani Rogers Regulatory Affairs TEL: (574) 371-4927, FAX (574) 371-4987, EMAIL TRogers1@dpyus.jnj.com
B. Device Information:
| Trade Name: | LPS (Limb Preservation System) Lower Extremity
Dovetail Intercalary |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Total Knee Prosthesis |
| Classification Name
and Regulatory Class: | Knee joint patellofemorotibial polymer/metal/polymer
semi-constrained cemented prosthesis: Class II per 21
CFR §888.3560 |
| Product Code: | 87 JWH |
C. Indications for Use:
The LPS Intercalary component is intended for use in primary and revision knee joint replacement and in oncology cases with the Limb Preservation System (LPS). The previously cleared indications for use for this systems are the following:
The Limb Preservation System (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., osteosarcoma, chondrosarcoma, 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, tibial stems, metaphyseal sleeves, and the non-porous coated straight and bowed stems are intended for cemented use only.
1
Page 2 of 2
510(k) Summary (continued) LPS Dovetail Intercalary
K0411085
D. Device Description:
The intercalary component serves as a segmental component in the previously cleared Limb Preservation System (LPS, K003182). The dovetail intercalary component is a 3piece assembly 55 mm in length. The three pieces are comprised of a male segment, a female segment and a connecting pin. The male-female parts connect as a dovetail connection and locked with a pin screwed through both segments. The dovetail intercalary component is made of cobalt chrome.
E. Substantial Equivalence:
The substantial equivalence of the LPS Dovetail Intercalary is substantiated by its similarity in sterilization, packaging and indications for use to the LPS (K003182 cleared on June 27, 2001). The design and materials of the LPS Dovetail Intercalary have been modified from the existing LPS Intercalary component cleared in K003182, however DePuy believes this new component is substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes extending from its body.
JUL 222 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tiffani D. Rogers Regulatory Affairs Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K041085
Trade/Device Name: LPS Lower Extremity Dovetail Intercalary Regulation Numbers: 21 CFR 888.3560 Regulation Names: Knee joint, patellofemorotibial, polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II
Product Codes: JWH Dated: April 23, 2004 Received: April 26, 2004
Dear Ms. Rogers:
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. Tiffani D. Rogers
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and A your and 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,
Sincerely yours,
Mark A. Melkersen
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): K041085 Device Name:
Indications for Use:
The LPS Intercalary component is intended for use in primary and revision knee joint replacement and in oncology cases with the Limb Preservation System (LPS). The previously cleared indications for use for this system are the following:
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., osteosarcoma, chondrosarcoma, 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, tibial stems, metaphyseal sleeves, and the non-porous coated straight and bowed stems 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)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| Page | of ______ |
|---|---|
| 510(k) Number | K041085 |