(73 days)
Not Found
No
The device description and intended use focus on the mechanical components and their function in knee and femoral replacement, with no mention of AI or ML technologies.
No.
A therapeutic device is one that treats a disease or condition. This device is a replacement for bone loss and deformities, not a treatment for a disease.
No
The device is described as an implantable component for knee joint replacement and bone reconstruction, not for diagnosis. While it mentions "Specific diagnostic indications for use," these refer to the medical conditions for which the device is used, not that the device itself performs diagnosis.
No
The device description explicitly states the device is a "modular, porous-coated, cone-shaped component" and "manufactured from titanium alloy," indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The DePuy LPS Diaphyseal and Metaphyseal Sleeves are described as modular, porous-coated components made from titanium alloy. They are designed to be implanted into the body during surgery.
- Intended Use: The intended use is for surgical implantation in primary and revision knee joint replacement to address bone loss and deformity. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The device is a surgical implant used in orthopedic procedures, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The DePuy LPS Diaphyseal and Metaphyseal Sleeves are intended for use in primary and revision knee joint replacement in the treatment of patients presenting bone loss and deformity associated with bone tumors resection, trauma, infection, and difficult revision arthroplasty.
The diaphyseal sleeve is intended to enhance the fit and fill of the diaphyseal femoral canal with distal femoral, proximal femoral, and proximal tibial replacements. The metaphyseal sleeve is intended to enhance the fit and fill of the metaphyseal region of the distal femur with femoral replacements.
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.
The diaphyseal and metaphyseal sleeves are intended for either cemented or cementless applications.
Product codes (comma separated list FDA assigned to the subject device)
87 MBH, JWH
Device Description
The DePuy LPS Diaphyseal Sleeve is a modular, porous-coated, cone-shaped component designed to enhance the fit and fill of the diaphyseal femoral canal with distal femoral, proximal femoral and proximal tibial replacements. The existing LPS Metaphyseal Sleeve (K040281) is a modular, porous-coated, flared component designed for enhanced fit and fill of the metaphyseal region of the distal femur with femoral replacements. Both are manufactured from titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint, mid-shaft portion of the femur, proximal femur, distal femur, total femur, 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
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
0
KO71417 Pose Is
AUG - 2 2007
510 (k) Summary
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46582
Establishment Registration Number: 1818910 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Rhonda Myer
Regulatory Affairs
Telephone: (574) 371-4927
Facsimile: (574) 371-4987
Electronic Mail: Rmyer7@dpyus.jnj.com |
| DATE PREPARED: | May 16, 2007 |
| PROPRIETARY NAME: | LPS Diaphyseal and Metaphyseal Sleeves |
| COMMON NAME: | Diaphyseal and Metaphyseal Sleeve Components |
| CLASSIFICATION: | 888.3565 Knee joint patellofemorotibial
metal/polymer porous-coated uncemented
prosthesis
888.3560 Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained
cemented prosthesis |
| DEVICE PRODUCT CODE: | 87 MBH, JWH |
| SUBSTANTIALLY EQUIVALENT
DEVICES: | DePuy Orthogenesis LPS System, K003182
DePuy LPS Metaphyseal Sleeve, K040281
DePuy Stability Hip Stem with Porocoat®,
K934457 |
DEVICE DESCRIPTION:
The DePuy LPS Diaphyseal Sleeve is a modular, porous-coated, cone-shaped component designed to enhance the fit and fill of the diaphyseal femoral canal with distal femoral, proximal femoral and proximal tibial replacements. The existing LPS Metaphyseal Sleeve (K040281) is a modular, porous-coated, flared component designed for enhanced fit and fill of the metaphyseal region of the distal femur with femoral replacements. Both are manufactured from titanium alloy.
INTENDED USE AND INDICATIONS:
Intended Use:
The DePuy LPS Diaphyseal and Metaphyseal Sleeves are intended for use in primary and revision knee joint replacement in the treatment of patients presenting bone loss and deformity associated with bone tumors resection, trauma, infection, and difficult revision arthroplasty.
1
Indications for Use:
The diaphyseal sleeve is intended to enhance the fit and fill of the diaphyseal femoral canal with distal femoral, proximal femoral, and proximal tibial replacements. The metaphyseal sleeve is intended to enhance the fit and fill of the metaphyseal region of the distal femur with femoral replacements.
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.
The diaphyseal and metaphyseal sleeves are intended for either cemented or cementless applications.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The substantial equivalence of the DePuy LPS Diaphyseal and Metaphyseal Sleeves is shown by the similarity in intended use, indications for use, materials and design to the existing DePuy Orthogenesis LPS, K003182 cleared on June 27, 2001, DePuy LPS Metaphyseal Sleeves, K040281 cleared on July 09, 2004, and DePuy Stability Hip Stem with Porocoat®, K934457.
2
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 representation of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profile graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Orthopaedics, Inc. % Ms. Rhonda Myer Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46582
AUG - 2 2007
Re: K071417
Trade/Device Name: LPS Diaphyseal and Metaphyseal Sleeves Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: July 24, 2007 Received: July 25, 2007
Dear Ms. Myer:
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
3
Page 2 - Ms. Rhonda Myer
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. 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) 276-0120. 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 A. Milliken
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): K071417
Device Name: LPS Diaphyseal and Metaphyseal Sleeves
Indications for Use:
The diaphyseal sleeve is intended to enhance the fit and fill of the diaphyseal femoral canal with distal femoral, proximal femoral, and proximal tibial replacements. The metaphyseal sleeve is intended to enhance the fit and fill of the metaphyseal region of the distal femur with femoral replacements.
The DePuy LPS is intended for use in replacement of the mid-shaft portion of the femur, The Dot af Er B is to it it to the 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. . pations benefitions of teoarthritis, 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.
The porous-coated diaphyseal and metaphyseal sleeves are intended for either cemented or cementless applications.
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 if needed.)
Page 6 of 61
DePuy LPS Additional Information (K071417)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Mark A. Mellerson | Page 1 of 1 | |
|---|---|---|
| (Division Sign-Off) | ||
| Division of General, Restorative, and Neurological Devices | ||
| 510(k) Number | K071417 | 5 |