(140 days)
No
The document describes a mechanical orthopedic implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is intended for use in replacement of parts of the femur and tibia due to various medical conditions, including malignant tumors, degenerative joint disease, and trauma, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is a knee replacement system intended for surgical implantation, not for diagnosing conditions.
No
The device description clearly indicates it is a physical implant (femoral adaptors, sleeves, stems, tibial tray) used in surgical procedures for bone replacement. There is no mention of software as the primary or sole component.
Based on the provided text, 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 and joint structures due to various conditions like tumors, degenerative diseases, trauma, and infection. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as a component for replacing parts of the femur and tibia, designed to connect other implant components. This aligns with a surgical implant, not a diagnostic device.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Therefore, the DePuy LPS System, including the ATTUNE Revision Sleeve LPS Femoral Adaptors, is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DePuy LPS System is intended for use in replacement of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnost ic indications for use include:
· malignant tumors (e.g., osteosarcomas, ciant 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 System 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 metaphyseal sleeves are intended for either cementless applications.
Product codes (comma separated list FDA assigned to the subject device)
JWH, MBH
Device Description
The ATTUNE® Revision Sleeve LPS™ Femoral Adaptors are designed as a component in the replacement of the natural articular surface of the knee joint or of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia. The ATTUNE Revision Sleeve LPS Femoral Adaptors are to be used to connect an ATTUNE Revision Femoral Sleeve to LPS System Components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, proximal, distal and/or total femur, and proximal tibia, knee joint
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 following tests were performed on the ATTUNE Revision Sleeve LPS Femoral Adaptor to demonstrate substantial equivalence of safety and efficacy with the predicate device:
- . taper connections tension and torsion strength
- biocompatibility testing
Magnetic Resonance Imaging safety evaluation testing was performed, and the tests evaluated the worstcase components and constructs for magnetically induced force, torque, image artifact and RF heating. The testing concluded that there are no safety issues related to magnetic field interactions under specific conditions identified in the labeling.
The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSI/AAMI ST 72:2019.
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.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
DePuy Ireland UC % Soraya Hori Project Leader Regulatory Affairs Depuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582
Re: K202248
Trade/Device Name: Attune Revision® Sleeve LPSTM Femoral Adaptors Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, MBH Dated: November 13, 2020 Received: November 16, 2020
Dear Soraya Hori:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
ATTUNE® Revision Sleeve LPS™Femoral Adaptors
Indications for Use (Describe)
The DePuy LPS System is intended for use in replacement of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnost ic indications for use include:
· malignant tumors (e.g., osteosarcomas, ciant 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 System 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 metaphyseal sleeves are intended for either cementless applications.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Page 1 of 1
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510(K) SUMMARY
(As required by 21 CFR 807.92 and 21 CFR 807.93)
Table 1: 510(K) Summary Submitter Information DePuy Ireland UC Name Loughbeg, Ringaskiddy Address Co. Cork Munster, IRELAND 574-372-7491 Phone number Fax number 574- 371-4987 Establishment Registration 3015516266 Number Name of contact person Soraya L. Hori Date prepared August 7, 2020 Name of device Trade or proprietary name ATTUNE® Revision Sleeve LPS™ Femoral Adaptors Common or usual name Total Knee Replacement Prosthesis Classification name Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis II Class Classification panel 87 Orthopedics Regulation 21 CFR 888.3560, 21 CFR 888.3565 Product Code(s) JWH. MBH Legally marketed device(s) to Primary: K071417 Limb Preservation System Diaphyseal and Metaphyseal which equivalence is claimed Sleeves Reference: K040281 Limb Preservation System Metaphyseal Sleeves The purpose of this submission is for the addition of a new adaptor option to Reason for 510(k) submission the DePuy Knee Revision portfolio. The ATTUNE® Revision Sleeve LPS™ Femoral Adaptors are designed as a Device description component in the replacement of the natural articular surface of the knee joint or of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia. The ATTUNE Revision Sleeve LPS Femoral Adaptors are to be used to connect an ATTUNE Revision Femoral Sleeve to LPS System Components. The DePuy LPS System is intended for use in replacement of the mid-shaft Indications for use 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:
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| | Characteristics | Subject Device:
ATTUNE Revision Sleeve LPS
Femoral Adaptor | Predicate Device:
LPS Femoral To Sleeve Adapter
K071417 (Primary), K040281
(Reference) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell
●
tumors, bone tumors) requiring extensive resection and
replacement; | Indications for Use | The DePuy LPS System 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
| The DePuy LPS System 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 System 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 metaphyseal sleeves are
intended for either cemented or cementless
applications. |
| patient conditions of noninflammatory degenerative joint disease
● | Material | Wrought, low carbon, cobalt chrome
molybdenum alloy | Wrought High-Carbon Co-Cr-Mo Bar or
Wrought, Low Carbon, Cobalt,
Molybdenum Bar |
| (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory
joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive
resection and replacement; | Locking Design/Mating
Design | Taper Lock | Taper Lock |
| revision cases for a failed previous prosthesis requiring extensive
● | Offset height options | +0MM, +5MM, +10MM | +0MM, +5MM, +10MM |
| resection and replacement; | Sterilization Method | Gamma Radiation | Gamma Radiation |
| severe trauma requiring extensive resection and replacement.
●
The LPS System is also intended for use in bone loss post-infection, where | Packaging | Polyurethane protective component
sealed in two Tyvek-lidded PETG blister
trays, packaged with an IFU and label
stock, all contained in a folding carton
with shrink wrap. | Polyurethane protective component sealed
in two Tyvek-lidded PETG blister trays,
packaged with an IFU and label stock, all
contained in a folding carton with shrink
wrap. |
| the surgeon has elected to excise the bone and replacement is required. | Shelf Life | 10 years | 10 years |
| The S-ROM tibial tray and the non-porous coated straight and bowed stems | | | |
| are intended for cemented use only. | | | |
| The porous-coated metaphyseal sleeves are intended for either cemented or | | | |
| cementless applications. | | | |
5
6
The subject device. ATTUNE Revision Sleeve LPS Femoral Adaptor, has the same intended use. indications for use, material, and locking mechanism as the predicate device, LPS Universal Femoral to Sleeve Adapter. The ATTUNE Revision Sleeve LPS Femoral Adaptor is designed to mate with a different femoral sleeve than the LPS Universal Femoral to Sleeve Adapter. The ATTUNE Revision Sleeve LPS Femoral Adaptor was tested for taper connections tension strength. It was found to be equivalent to the LPS Universal Femoral to Sleeve Adaptor.
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The following tests were performed on the ATTUNE Revision Sleeve LPS Femoral Adaptor to demonstrate substantial equivalence of safety and efficacy with the predicate device:
- . taper connections tension and torsion strength
- biocompatibility testing
Magnetic Resonance Imaging safety evaluation testing was performed, and the tests evaluated the worstcase components and constructs for magnetically induced force, torque, image artifact and RF heating. The testing concluded that there are no safety issues related to magnetic field interactions under specific conditions identified in the labeling.
The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSI/AAMI ST 72:2019.
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
Clinical testing was not required to demonstrate substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The subject DePuy ATTUNE Revision Sleeve LPS Femoral Adaptor are substantially equivalent to the predicate LPS Universal Femoral to Sleeve Adapter (K040281, K071417).