(154 days)
No
The document describes a mechanical implant (metaphyseal sleeve) and its compatibility with existing knee replacement systems. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes.
The device, a metaphyseal sleeve, is intended for use in knee joint replacement and oncology cases to fill metaphyseal defects, and it is part of systems (LPS, S-ROM, P.F.C. Sigma) used to treat various medical conditions such as malignant tumors, degenerative and inflammatory joint diseases, and severe trauma, all of which fall under the scope of therapeutic applications.
No
Explanation: The device described is a metaphyseal sleeve, which is a component of knee replacement systems. Its purpose is to fill metaphyseal defects and join other components, not to diagnose medical conditions or provide diagnostic information. The diagnostic indications listed are for the conditions that necessitate the use of the device (malignant tumors, degenerative joint diseases, etc.), not for the device itself to perform a diagnosis.
No
The device description clearly states the device is a "titanium sleeve" and describes its physical characteristics and how it mates with other hardware components. This indicates it is a physical medical device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Description and Intended Use: The description clearly states that the metaphyseal sleeve is a component used in surgical procedures for knee joint replacement and oncology cases. It is a physical implant designed to fill bone defects and connect other prosthetic components.
- Lack of Specimen Handling: There is no mention of the device being used to collect, prepare, or analyze any biological specimens.
- Surgical Application: The intended use and device description focus entirely on its role as a physical implant within the body during surgery.
Therefore, the metaphyseal sleeve falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The metaphyseal sleeve is intended for use in primary and revision knee joint replacement and in oncology cases. The metaphyseal sleeve is used to fill metaphyseal defects in the distal femur and joins a knee femoral component with an intramedullary stem. The sleeve may be used across several product lines: the Limb Preservation System (LPS), the S-ROM system, and the fixed platform portion of the P.F.C. Sigma system. The previously cleared indications for use for these systems:
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 drithritis, 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 metaphyseal sleeve, the distal femoral component, the tibial components, and the nonporous coated straight and bowed stems are intended for cemented use only.
The S-ROM Modular Total Knee System was cleared as the "NOILES Posterior Stabilized Knee."
The NOILES Posterior Stabilized Knee is indicated for use with PMMA bone cement in primary or revised cases in patients:
- who have reached skeletal maturity and .
- for whom the surgeon has decided to resect both cruciate ligaments or whose cruciate . ligaments are absent or incompetent due to the following conditions: rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, and arthritis secondary to a variety of diseases and anomalies, failure of a previous knee reconstruction procedure, trauma.
The P.F.C. Sigma Knee System is indicated for use as a total knee replacement for patients suffering from severe pain and disability due to permanent structural damage in the knee joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, or pseudogout.
This damage may also be a result of trauma or failed prior surgical intervention.
The P.F.C. Sigma Knee System is indicated for use with polymethylmethacrylate (PMMA) bone cement.
Product codes
87 JWH
Device Description
The metaphyseal sleeve is a component to the previously cleared Limb Preservation System (LPS). The titanium sleeve is used to fill metaphyseal defects in the distal femur and joins a knee femoral component with an intramedullary stem. The sleeve is cone-shaped, with an outer stepped anatomical taper to fill the metaphyseal region of the distal femur. All but the final four steps of the sleeve are porous coated. The sleeve ranges in size from 31 to 46mm, as measured at the widest (M/L width) portion of the sleeve.
Through the use of adapters, the sleeve is compatible on its proximal and distal ends with femoral stems and distal femoral components. The femoral stems and distal femoral components are from previously cleared DePuy knee systems such as the Limb Preservation System, the S-ROM® NOILES Total Knee System and the fixed platform of the P.F.C. Σ System.
On the distal end, the sleeves either mate directly with the posts on previously cleared femoral components (e.g., the S-ROM femoral) or, through the use of one of the two wrought cobalt chrome femoral to sleeve adapters, mate with previously cleared femoral components that do not have posts (e.g., the LPS femoral, the P.F.C. Σ TC3 or the P.F.C. Σ PS femoral). These adapters will be available in 3 offsets: +0, +5 and +10 millimeters.
On the proximal side, the sleeves mate with previously cleared stems, either directly (when using an S-ROM stem) or through the use of the titanium LPS P.F.C. Stem to Sleeve Adapter (when using a P.F.C. type fluted or cemented stem).
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, distal and/or total femur, and proximal tibia, distal femur
Indicated Patient Age Range
who have reached skeletal maturity
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
04-02-81
Page 1 of 3
510(k) Summary LPS Metaphyseal Sleeve
A. Contact Person:
JUL 0 9 2004
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:
| Trade Name: | LPS Metaphyseal Sleeve (Limb Preservation System) |
|---|---|
| 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 metaphyseal sleeve is intended for use in primary and revision knee joint replacement and in oncology cases. The metaphyseal sleeve is used to fill metaphyseal defects in the distal femur and joins a knee femoral component with an intramedullary stem. The sleeve may be used across several product lines: the Limb Preservation System (LPS), the S-ROM system, and the fixed platform portion of the P.F.C. Sigma system. The previously cleared indications for use for these systems:
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 drithritis, 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 metaphyseal sleeve, the distal femoral component, the tibial components, and the nonporous coated straight and bowed stems are intended for cemented use only.
1
510(k) Summary (continued) LPS Metaphyseal Sleeve
C. Indications for Use (continued):
The S-ROM Modular Total Knee System was cleared as the "NOILES Posterior Stabilized Knee."
The NOILES Posterior Stabilized Knee is indicated for use with PMMA bone cement in primary or revised cases in patients:
- who have reached skeletal maturity and .
- for whom the surgeon has decided to resect both cruciate ligaments or whose cruciate . ligaments are absent or incompetent due to the following conditions: rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, and arthritis secondary to a variety of diseases and anomalies, failure of a previous knee reconstruction procedure, trauma.
The P.F.C. Sigma Knee System is indicated for use as a total knee replacement for patients suffering from severe pain and disability due to permanent structural damage in the knee joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, or pseudogout.
This damage may also be a result of trauma or failed prior surgical intervention.
The P.F.C. Sigma Knee System is indicated for use with polymethylmethacrylate (PMMA) bone cement.
D. Device Description:
The metaphyseal sleeve is a component to the previously cleared Limb Preservation System (LPS). The titanium sleeve is used to fill metaphyseal defects in the distal femur and joins a knee femoral component with an intramedullary stem. The sleeve is cone-shaped, with an outer stepped anatomical taper to fill the metaphyseal region of the distal femur. All but the final four steps of the sleeve are porous coated. The sleeve ranges in size from 31 to 46mm, as measured at the widest (M/L width) portion of the sleeve.
Through the use of adapters, the sleeve is compatible on its proximal and distal ends with femoral stems and distal femoral components. The femoral stems and distal femoral components are from previously cleared DePuy knee systems such as the Limb Preservation System, the S-ROM® NOILES Total Knee System and the fixed platform of the P.F.C. Σ System.
On the distal end, the sleeves either mate directly with the posts on previously cleared femoral components (e.g., the S-ROM femoral) or, through the use of one of the two wrought cobalt chrome femoral to sleeve adapters, mate with previously cleared femoral components that do not have posts (e.g., the LPS femoral, the P.F.C. Σ TC3 or the P.F.C. Σ PS femoral). These adapters will be available in 3 offsets: +0, +5 and +10 millimeters.
On the proximal side, the sleeves mate with previously cleared stems, either directly (when using an S-ROM stem) or through the use of the titanium LPS P.F.C. Stem to Sleeve Adapter (when using a P.F.C. type fluted or cemented stem).
2
Ko40281
3
510(k) Summary (continued) LPS Metaphyseal Sleeve
E. Substantial Equivalence:
The substantial equivalence of the LPS is substantiated by its similarity:
- in sterilization, packaging and indications for use to the LPS (K003182 cleared on . June 27, 2001).
- in design, materials and indications for use to the femoral sleeve found in the S-. ROM/Noiles PS Total Knee System (K870730 cleared on May 26, 1987).
3
Image /page/3/Picture/2 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 emblem featuring three horizontal lines that curve upwards, resembling an abstract representation of the human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dina L. Weissman, J.D. Legal Consultant, Regulatory Affairs DePuy, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581
JUL 0 9 2004
Re: K040281
Trade/Device Name: LPS Metaphyseal Sleeve Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Code: JWH
Dated: June 1, 2004 Received: June 3, 2004
Dear Ms. Weissman:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your because be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the enorouse) to regists and ment date of the Medical Device Amendments, or to connineres prior to May 20, 1978, ac excordance with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, there covisions 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 If your device is classinod (over as controls. Existing major regulations affecting your device can may or subject to been the deral 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 I that FDA has made a determination that your device complies with other requirements of the Act that 127 Mas Intatutes and regulations administered by other Federal agencies. You must or any I 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
4
Page 2 - Dina L. Weissman, J.D.
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality byections (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) rms letter with and the FDA finding of substantial equivalence of your device to a legally premated predicated 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 If you atem 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 other general mornational 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,
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
5
Indications for Use
K040281 510(k) Number (if known): LPS Metaphyseal Sleeve Device Name:
Indications for Use:
The metaphyseal sleeve is used to fill metaphyseal defects in the distal femur and joins a knee femoral I he netaphysear never is assure them. The metaphyseal sleeve is intended for use in primary and component will and in minuneout and in oncology cases across several product lines: the Limb Preservation It vision alled John ropidounten and the P.F.C. Sigma system. The previously cleared indications for use for these systems 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., 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; -
· corevision 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 metaphyseal sleeve, the distal femoral component, the tibial components, and the non-porous coated straight and bowed stems are intended for cemented use only.
(CONTINUED ON THE NEXT PAGE)
Over-The-Counter Use AND/OR Prescription Use XXXXX (Part 21 CFR 801 Subpart D) (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)
Page 1 of 2 and Neurological Devices
(Posted November 13, 2003)
510(k) Number K040281
6
The S-ROM Modular Total Knee System was cleared as the "NOILES Posterior Stabilized Knee." The NOILES Posterior Stabilized Knee is indicated for use with PMMA bone cement in primary or revised cases in patients:
- who have reached skeletal maturity and .
- for whom the surgeon has decided to resect both cruciate ligaments or whose cruciate ligaments are . absent or incompetent due to the following conditions: rheumatoid arthritis, osteoarthritis, posttraumatic arthritis, and arthritis secondary to a variety of diseases and anomalies, failure of a previous knee reconstruction procedure, trauma.
The P.F.C.® Sigma Knee System is indicated for use as a total knee replacement for patients suffering from severe pain and disability due to permanent structural damage in the knee joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, or pseudogout.
This damage may also be a result of trauma or failed prior surgical intervention.
The P.F.C.® Sigma Knee System is indicated for use with polymethylmethacrylate (PMMA) bone cement.