(66 days)
No
The document describes a mechanical orthopedic implant system for bone replacement and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No.
The device is an orthopedic implant (prosthesis) designed for structural replacement rather than for direct therapeutic intervention. Its primary function is to replace resected bone sections and provide structural support, which is a restorative/reconstructive function.
No.
The DePuy LPS is a device intended for surgical replacement of bone portions, particularly in cases requiring extensive resection. While its indications are related to conditions that are diagnosed (e.g., malignant tumors, degenerative joint disease), the device itself is a prosthetic implant, not a tool used to diagnose those conditions.
No
The device description clearly describes a physical implantable medical device (proximal tibial component) made of materials like Co-Cr-Mo with features like tapers, stems, and polished surfaces, which are characteristic of hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing bone in the femur and tibia. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a modular component designed to replace a portion of the tibia, focusing on its physical characteristics and how it articulates with other components. This aligns with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information.
- Anatomical Site: The device is used within the body (femur and tibia), which is characteristic of an implant, not an IVD.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (within the body) for structural replacement.
N/A
Intended Use / 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., theumatoid 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 S-ROM Tibial Tray and the non-porous coated straight and bowed stems are intended for cemented use only.
Product codes
KRO
Device Description
The DePuy LPS Proximal Tibial Component is a modular component that is designed to replace the proximal portion of the tibia. 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 distal end of the LPS Proximal Tibial Component has a female Morse-type taper that is designed to accept either a DePuy LPS Segment Component or a tibial stem. The proximal/superior surface is designed with a central stem hole to allow it to accept the stem of the LPS tibial plateau/hinge assembly. The top surface has a highly polished mirror pr nish for smooth articulation with the polyethylene component of the tibial plateau/hinge assembly. The anterior surface has a Porocoat beaded Co-Cr-Mo porous coating.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
510(k) SUMMARY
OC7 1 3 2006
| NAME OF FIRM: | DePuy Orthopaedics Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 Establishment Registration No.: 1818910 |
|---|---|
| 510(K) CONTACT: | Nancy Friddle Team Leader, Regulatory Affairs Tel: (574) 371-4923 Fax: (574) 371-4987 |
| TRADE NAME: | DePuy LPS Proximal Tibial Component |
| COMMON NAME: | Proximal Tibial Replacement |
| CLASSIFICATION: | Knee joint femorotibial metal/polymer constrained cemented prosthesis: Class II per 21 CFR §888.3510 |
| DEVICE PRODUCT CODE: | KRO |
| SUBSTANTIALLY EQUIVALENT DEVICES: | DePuy Orthogenesis LPS Proximal Tibial Replacement System (K011810) |
| DePuy LPS (K033959) |
DEVICE DESCRIPTION:
The DePuy LPS Proximal Tibial Component is a modular component that is designed to replace the proximal portion of the tibia. 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 distal end of the LPS Proximal Tibial Component has a female Morse-type taper that is designed to accept either a DePuy LPS Segment Component or a tibial stem. The proximal/superior surface is designed with a central stem hole to allow it to accept the stem of the LPS tibial plateau/hinge assembly. The top surface has a highly polished mirror pr nish for smooth articulation with the polyethylene component of the tibial plateau/hinge assembly. The anterior surface has a Porocoat beaded Co-Cr-Mo porous coating.
1
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., theumatoid 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 S-ROM Tibial Tray and the non-porous coated straight and bowed stems are intended for cemented use only.
BASIS FOR SUBSTANTIAL EQUIVALENCE:
DePuy believes that this device is substantially equivalent to the Orthogenesis LPS Proximal Tibial Replacement System based on similarities in design and indications and the + revits of physical testing and analysis compared to the predicate devices.
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 stylized eagle with three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 3 2006
DePuy Orthopaedics, Inc. % Ms. Nancy Friddle Team Leader, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46581
Re: K062301
Trade/Device Name: LPS Proximal Tibial Component Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femortibial metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: KRO Dated: October 5, 2006 Received: October 6, 2006
Dear Mr. 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, 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. Nancy 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 Office of Compliance at (240) 276-0210 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K062301
Device Name: DePuy LPS Proximal Tibial Component
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., theumatoid 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 S-ROM Tibial Tray and the non-porous coated straight and bowed stems are intended for cemented use only.
| Prescription Use
(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use
(21 CFR 801 Subpart C) |
| ------------------------------------------------- | --- | -------- | ------------------------------------------------ |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K062301 |
|---|---|
| --------------- | --------- |
| Page 1 of 1 |
|---|
| ------------- |
Page 25