(94 days)
No
The device description and performance studies focus on the mechanical and material properties of the implants, with no mention of AI/ML capabilities or data processing.
Yes
The device is a medical implant (total knee replacement system) designed to treat painful and/or disabled joints resulting from various conditions like osteoarthritis, post-traumatic arthritis, and rheumatoid arthritis, which are conditions that require therapeutic intervention.
No
The provided text describes and lists indications for several orthopedic implants for knee and limb replacement surgeries. These devices are surgically implanted to replace damaged or diseased joints or bones, which is a treatment, not a diagnostic process. While diagnostic indications are mentioned for the LPS System, the device itself is the implant used for treatment, not a tool for diagnosis.
No
The device description clearly outlines physical components like femoral, tibial, and patellar implants made of metal and polyethylene, which are hardware. The indications for use also describe surgical procedures involving these physical implants.
Based on the provided information, these devices are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The descriptions clearly state that these are prosthetic implants designed to replace parts of the knee joint or femur and tibia. They are physical devices implanted into the body.
- Intended Use: The intended use is to treat conditions like osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, failed implants, tumors, trauma, and infection by replacing damaged bone and joint structures. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
Therefore, these devices fall under the category of implantable medical devices rather than In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
ATTUNE™ Total Knee System Indications for Use Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.
ATTUNE™ Cementless Knee System Indications for Use The ATTUNE™ Cementless CR and PS Femoral Components are intended for cementless use within the ATTUNE™ Total Knee Replacement System.
Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present).
LPS TM Limb Preservation System 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 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.
Sigma™ High Performance (HP) Partial Knee System Indications for Use The SIGMA™ High Performance Partial Knee System is indicated for single compartmental knee replacement in skeletally mature individuals with osteoarthritis, post-traumatic arthritis of the tibiofemoral surfaces or a history of gout or pseudogout. All components are intended for CEMENTED USE ONLY.
Product codes
KRO, OIY, MBH, JWH, NPJ, HRY, KRR
Device Description
ATTUNE™ Total Knee System: A Total Knee Prosthesis is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design.
ATTUNE™ Cementless Knee System: A Total Knee Prosthesis is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant with or without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design.
LPS™ Limb Preservation System: The DePuy LPSTM Limb Preservation System is designed for the replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia. The DePuy LPS system offers a variety of component options (including, but not limited to, proximal femoral bodies, segmental components, distal femoral components, femoral stems, tibial stems, proximal tibial components, hinged tibial insert bearings, metaphyseal sleeves, and adapters). The components, which can be used in conjunction with certain components from other systems, are for treatment of patients presenting bone loss and deformity associated with bone tumors resection, trauma, infection, and difficult revision arthroplasty. A total femoral replacement is possible in those cases where no part of the femur can be salvaged.
Sigma™ High Performance (HP) Partial Knee System: The DePuy SIGMATM High Performance Partial Knee System is a single compartmental knee prosthesis, composed of individually packaged femoral, and tibial components designed to be used in various combinations to replace the natural articular surfaces of the knee joint. The unicompartmental femoral components are Co-Cr-Mo metal implants. The metal backed tibial components are Co-Cr-Mo with polyethylene inserts. The all-polyethylene unicompartmental tibial component are manufactured from polyethylene. The unicompartmental femoral components are designed for individuals who require a higher than normal degree of flexion (up to 155°).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee Joint, Femur, Tibia
Indicated Patient Age Range
Skeletally mature individuals (for Sigma™ High Performance (HP) Partial Knee System). Younger patients considered for total knee replacement if benefits outweigh risks.
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)
No clinical tests were conducted to demonstrate substantial equivalence. Non-clinical tests were performed to determine Magnetic Resonance (MR) Safety, including:
- ASTM F2503-23 - Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
- ASTM F2182 -19E2 - Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants during Magnetic Resonance
- ASTM F2052-21 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- ASTM F2213-17 - Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
- ASTM F2119-07 - Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
The 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)
K111433, K170806, K140881, K091453, K033959, K003182, K070267, K070849, K061648
Reference Device(s)
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
Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 21, 2024
DePuy Ireland UC % Meagan Robles Regulatory Affairs Project Leader DePuy Synthes Loughbeg Ringaskiddy, Co. Cork Munster Ireland
Re: K233980
Trade/Device Name: ATTUNE Total Knee System. ATTUNE Cementless Knee System. LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System Regulation Number: 21 CFR 888.3510 Regulation Name: Knee Joint Femorotibial Metal/Polymer Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KRO, OIY, MBH, JWH, NPJ, HRY, KRR Dated: December 15, 2023 Received: December 18, 2023
Dear Meagan Robles:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Ouality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Lixin Liu -S
Lixin Liu, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
ATTUNE™ Total Knee System;
ATTUNE™ Cementless Knee System :
LPS™ Limb Preservation System;
Sigma™ High Performance (HP) Partial Knee System
Indications for Use (Describe)
ATTUNE™ Total Knee System Indications for Use
Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.
ATTUNE™ Cementless Knee System Indications for Use
The ATTUNE™ Cementless CR and PS Femoral Components are intended for cementless use within the ATTUNE™ Total Knee Replacement System.
Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present).
LPS TM Limb Preservation System 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 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.
Sigma™ High Performance (HP) Partial Knee System Indications for Use
The SIGMA™ High Performance Partial Knee System is indicated for single compartmental knee replacement in skeletally mature individuals with osteoarthritis, post-traumatic arthritis of the tibiofemoral surfaces or a history of gout or pseudogout. All components are intended for CEMENTED USE ONLY.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/Picture/0 description: The image shows the logo for DePuy Synthes, a company that specializes in orthopedics. The logo features a red graphic element on the left, followed by the company name in gray, with the words "THE ORTHOPAEDICS COMPANY of Johnson & Johnson" in smaller font below. The logo is simple and modern, and the use of red and gray gives it a professional look.
510(K) SUMMARY
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| Contact Details | |
|---|---|
| Applicant Name | DePuy Ireland UC |
| Applicant Address | Loughbeg, Ringaskiddy |
| Co. Cork Munster, IRELAND | |
| Applicant Contact Telephone | 574-400-6438 |
| Applicant Contact | Meagan Robles |
| Applicant Contact Email | Mroble10@its.jnj.com |
| Correspondent Name | DePuy Orthopaedics, Inc. |
| Correspondent Address | 700 Orthopaedic Drive Warsaw IN 46582 United States |
| Correspondent Contact | |
| Telephone | 574-400-6438 |
| Correspondent Contact | Meagan Robles |
| Correspondent Contact | |
| Mroble10@its.jnj.com | |
| Date prepared | December 21, 2023 |
| Name of device | |
| Trade or proprietary name | Attune ™ Total Knee System |
| Common or usual name | Total Knee Replacement Prosthesis |
| Classification name | 21 CFR 888.3560 – Knee joint patellofemorotibial polymer/metal/polymer |
| semi-constrained cemented prosthesis | |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | Class II - 21 CFR 888.3560 |
| Product Code(s) | JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, |
| Polymer/Metal/Polymer | |
| OIY: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, | |
| Polymer + Additive/Metal/Polymer + Additive | |
| Legally marketed device(s) to | |
| which equivalence is claimed | Primary Predicate: K111433 - DePuy Attune ™ Knee System |
| Secondary Predicate: K170806 – ATTUNE Cemented Tibial Base, Fixed | |
| Bearing | |
| Reference Devices: | |
| K232303 - ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome | |
| Patella and Medialized Anatomic Patella with AFFIXIUMTM 3DP | |
| Technology | |
| K212746 & K230295 - ATTUNE Revision Cones | |
| Reason for 510(k) submission | In accordance with Section 510(k) of the Medical Device Amendments of |
| 1976 and Subpart E of Part 807, Title 21 of the Code of Federal Regulations, | |
| and as per the FDA Guidance, Bundling Multiple Devices or Multiple | |
| Indications in a Single Submission: Guidance for Industry and FDA Staff | |
| (June 2007), DePuy Ireland UC has compiled a Bundled Traditional 510(k) | |
| Premarket Notification to modify labeling to include updated MRI | |
| compatibility information for DePuy ATTUNE™ Total Knee System | |
| (K111433, K170806). Updates include modernizing and standardizing the | |
| language of the Instructions for Use (IFU) and labels. | |
| Device description | A Total Knee Prosthesis is composed of individually packaged femoral, tibial |
| and patellar components designed to replace the natural articular surface of the | |
| knee joint. The femoral component is a metal implant without a porous | |
| coating. The tibial component may be an all polyethylene component or | |
| comprised of a metal tibial base without porous coating, and a polyethylene | |
| insert and locking components. The patella component may be of an all | |
| polyethylene design. | |
| Intended use of the device | Total knee arthroplasty is intended to provide increased patient mobility and |
| reduced pain by replacing the damaged knee joint articulation in patients | |
| where there is evidence of sufficient sound bone to seat and support the | |
| components. Total knee replacement may be considered for younger patients | |
| if, in the opinion of the surgeon, an unequivocal indication for total knee | |
| replacement outweighs the risks associated with the age of the patient, and if | |
| limited demands regarding activity and knee joint loading can be assured. | |
| This includes severely disabled patients with multiple joint involvement for | |
| whom a gain in knee mobility may lead to an expectation of significant | |
| improvement in the quality of their lives. | |
| Indications for use | Candidates for total knee replacement include patients with a severely |
| painful and/or severely disabled joint resulting from osteoarthritis, post- | |
| traumatic arthritis, rheumatoid arthritis, or a failed previous implant. | |
| Substantial Equivalence | There are no changes in design, manufacturing, principle of operation, |
| indication, or intended use. The only change is the addition of Magnetic | |
| Resonance (MR) safety information in the Instructions for Use (IFU) and the | |
| update of language in the IFU as discussed in Performance Testing - | |
| Bench. |
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Image /page/5/Picture/0 description: The image shows the logo for DePuy Synthes, a company that specializes in orthopedics. The logo features a red symbol resembling a stylized spine or interconnected network, followed by the company name in gray, sans-serif font. Below the company name, in smaller font, is the tagline "THE ORTHOPAEDICS COMPANY of Johnson & Johnson", with "Johnson & Johnson" written in a distinctive script font.
6
Image /page/6/Picture/1 description: The image shows the logo for DePuy Synthes, a company that specializes in orthopedics and is part of Johnson & Johnson. The logo features a red symbol resembling a stylized bone or joint, followed by the company name in gray, with the tagline "THE ORTHOPAEDICS COMPANY of Johnson & Johnson" underneath. The Johnson & Johnson part of the tagline is in red.
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The following tests were performed (per FDA's Testing and Labeling Medical Devices for Safety in the Magnetic
Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff, October 2023) to determine Magnetic Resonance (MR) Safety:
ASTM F2503-23 - Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
ASTM F2182 -19E2 - Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants during Magnetic Resonance
ASTM F2052-21 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ASTM F2213-17 - Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
ASTM F2119-07 - Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
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
No clinical tests were conducted to demonstrate substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The subject DePuy ATTUNE Total Knee System are substantially equivalent to the predicate ATTUNE Total Knee System (K111433, K170806).
| Contact Details | |
|---|---|
| Applicant Name | DePuy Ireland UC |
| Applicant Address | Loughbeg, Ringaskiddy |
| Co. Cork Munster, IRELAND | |
| Applicant Contact Telephone | 574-400-6438 |
| Applicant Contact | Meagan Robles |
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Image /page/7/Picture/1 description: The image shows the logo for DePuy Synthes, which is the orthopedics company of Johnson & Johnson. The logo features a red symbol on the left, followed by the company name in gray. Below the company name, there is a smaller text indicating that it is the orthopedics company of Johnson & Johnson, with the Johnson & Johnson part in red.
| Applicant Contact Email | Mroble10@its.jnj.com |
|---|---|
| Correspondent Name | DePuy Orthopaedics, Inc. |
| Correspondent Address | 700 Orthopaedic Drive Warsaw IN 46582 United States |
| Correspondent Contact | |
| Telephone | 574-400-6438 |
| Correspondent Contact | Meagan Robles |
| Correspondent Contact | |
| Mroble10@its.jnj.com | |
| Date prepared | December 21, 2023 |
| Name of device | |
| Trade or proprietary name | ATTUNE ™ Cementless Knee System |
| Common or usual name | Total Knee Prosthesis |
| Classification name | 21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous- |
| coated uncemented prosthesis | |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | Class II - 21 CFR 888.3565 |
| Product Code(s) | MBH: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, |
| Uncemented, Porous, Coated, Polymer/Metal/Polymer | |
| JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, | |
| Polymer/Metal/Polymer | |
| Legally marketed device(s) to | |
| which equivalence is claimed | Primary Predicate: K140881 - ATTUNE ™ Knee System- Cementless CR |
| and PS Femoral Components | |
| Reference Devices: | |
| K232303 – ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome | |
| Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP | |
| Technology | |
| K212746 & K230295 - ATTUNE Revision Cones | |
| Reason for 510(k) submission | In accordance with Section 510(k) of the Medical Device Amendments of |
| 1976 and Subpart E of Part 807, Title 21 of the Code of Federal Regulations, | |
| and as per the FDA Guidance, Bundling Multiple Devices or Multiple | |
| Indications in a Single Submission: Guidance for Industry and FDA Staff | |
| (June 2007), DePuy Ireland UC has compiled a Bundled Traditional 510(k) | |
| Premarket Notification to modify labeling to include updated MRI | |
| compatibility information for DePuy, ATTUNE™ Cementless Knee System | |
| (K140881). Updates include modernizing and standardizing the language of | |
| the Instructions for Use (IFU) and labels. | |
| Device description | A Total Knee Prosthesis is composed of individually packaged femoral, tibial |
| and patellar components designed to replace the natural articular surface of the | |
| knee joint. The femoral component is a metal implant with or without a porous | |
| coating. The tibial component may be an all polyethylene component or | |
| comprised of a metal tibial base without porous coating, and a polyethylene | |
| insert and locking components. The patella component may be of an all | |
| polyethylene design. | |
| Intended use of the device | Total knee arthroplasty is intended to provide increased patient mobility and |
| reduced pain by replacing the damaged knee joint articulation in patients where | |
| there is evidence of sufficient sound bone to seat and support the components. | |
| Total knee replacement may be considered for younger patients if, in the | |
| opinion of the surgeon, an unequivocal indication for total knee replacement | |
| outweighs the risks associated with the age of the patient, and if limited | |
| demands regarding activity and knee joint loading can be assured. This includes | |
| severely crippled disabled patients with multiple joint involvement for whom a | |
| gain in knee mobility may lead to an expectation of significant improvement in | |
| the quality of their lives. | |
| Indications for use | The ATTUNE™ Cementless CR and PS Femoral Components are intended |
| for cementless use within the ATTUNE™ Total Knee Replacement System. | |
| Candidates for total knee replacement include patients with a severely | |
| painful and/or severely disabled joint resulting from osteoarthritis, post- | |
| traumatic arthritis, or a failed previous implant (provided that adequate bone | |
| is present). | |
| Substantial Equivalence | There are no changes in design, manufacturing, principle of operation, |
| indication, or intended use. | |
| The only change is the addition of Magnetic Resonance (MR) safety | |
| information in the Instructions for Use (IFU) and the update of language in the | |
| IFU as discussed in Performance Testing - Bench. |
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Image /page/8/Picture/1 description: The image displays the logo for "DePuy Synthes, the orthopedics company of Johnson & Johnson". The logo features a red abstract symbol resembling a stylized spine or interconnected loops on the left. To the right of the symbol, the words "DePuy Synthes" are written in a gray, sans-serif font. Below "DePuy Synthes", the text "THE ORTHOPAEDICS COMPANY of Johnson & Johnson" is written in a smaller font size.
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The following tests were performed (per FDA's Testing and Labeling Medical Devices for Safety in the Magnetic
Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff, October 2023) to determine Magnetic Resonance (MR) Safety:
ASTM F2503-23 - Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
9
Image /page/9/Picture/1 description: The image shows the logo for DePuy Synthes, The Orthopaedics Company of Johnson & Johnson. The logo features a red abstract symbol on the left, followed by the company name in gray, with "DePuy" slightly larger than "Synthes". Below the company name, in smaller gray font, is the text "THE ORTHOPAEDICS COMPANY of", and then "Johnson & Johnson" in red script.
ASTM F2182 -19E2 - Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants during Magnetic Resonance
ASTM F2052-21 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ASTM F2213-17 - Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
ASTM F2119-07 - Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
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
No clinical tests were conducted to demonstrate substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The subject DePuy ATTUNE Cementless Knee System are substantially equivalent to the predicate ATTUNE Knee System - Cementless (K140881).
| Contact Details | |
|---|---|
| Applicant Name | DePuy Ireland UC |
| Applicant Address | Loughbeg, Ringaskiddy |
| Co. Cork Munster, IRELAND | |
| Applicant Contact Telephone | 574-400-6438 |
| Applicant Contact | Meagan Robles |
| Applicant Contact Email | Mroble10@its.jnj.com |
10
Image /page/10/Picture/1 description: The image shows the logo for DePuy Synthes, a company that specializes in orthopedics. The logo features a red symbol on the left, followed by the company name in gray. Below the company name, it says "THE ORTHOPAEDICS COMPANY of Johnson & Johnson" in a smaller font.
| Correspondent Name | DePuy Orthopaedics, Inc. |
|---|---|
| Correspondent Address | 700 Orthopaedic Drive Warsaw IN 46582 United States |
| Correspondent Contact | |
| Telephone | 574-400-6438 |
| Correspondent Contact | Meagan Robles |
| Correspondent Contact | |
| Mroble10@its.jnj.com | |
| Date prepared | December 21, 2023 |
| Name of device | |
| Trade or proprietary name | LPS - Limb Preservation System |
| Common or usual name | Total Femur Replacement Prosthesis |
| Proximal Tibial Replacement Prosthesis | |
| Classification name | 21 CFR 888.3510 - Knee Joint Femorotibial Metal/Polymer Constrained Cemented Prosthesis |
| 21 CFR 888.3560 - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained | |
| cemented prosthesis | |
| 21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented | |
| prosthesis | |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | Class II - 21 CFR 888.3510; 21 CFR 888.3560; 21 CFR 888.3365 |
| Product Code(s) | JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, |
| Polymer/Metal/Polymer | |
| MBH: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, | |
| Uncemented, Porous, Coated, Polymer/Metal/Polymer | |
| KRO: Prosthesis, Knee, Femorotibial, Constrained, Cemented, | |
| Metal/Polymer | |
| Legally marketed device(s) to | |
| which equivalence is claimed | Primary Predicate: K091453 - DePuy LPS Universal Hinge Insert Assembly |
| Secondary Predicates: K033959 – LPS ; K003182 – Orthogenesis LPS | |
| System | |
| Reference Devices: | |
| K232303 - ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome | |
| Patella and Medialized Anatomic Patella with AFFIXIUMTM 3DP | |
| Technology | |
| K212746 & K230295 - ATTUNE Revision Cones | |
| Reason for 510(k) submission | In accordance with Section 510(k) of the Medical Device Amendments of |
| 1976 and Subpart E of Part 807, Title 21 of the Code of Federal Regulations, | |
| and as per the FDA Guidance, Bundling Multiple Devices or Multiple | |
| Indications in a Single Submission: Guidance for Industry and FDA Staff | |
| (June 2007), DePuy Ireland UC has compiled a Bundled Traditional 510(k) | |
| Premarket Notification to modify labeling to modernize and standardize the | |
| language of the Instructions for Use (IFU) and labels with continued use of | |
| "Safety in MRI not evaluated" unknownfor DePuy LPSTM - Limb Preservation | |
| System (K091453, K033959, K003182). | |
| Device description | The DePuy LPSTM Limb Preservation System is designed for the |
| replacement of the mid-shaft portion of the femur, proximal, distal and/or | |
| total femur, and proximal tibia. The DePuy LPS system offers a variety of | |
| component options (including, but not limited to, proximal femoral bodies, | |
| segmental components, distal femoral components, femoral stems, tibial | |
| stems, proximal tibial components, hinged tibial insert bearings, metaphyseal | |
| sleeves, and adapters). The components, which can be used in conjunction | |
| with certain components from other systems, are for treatment of patients | |
| presenting bone loss and deformity associated with bone tumors resection, | |
| trauma, infection, and difficult revision arthroplasty. A total femoral | |
| replacement is possible in those cases where no part of the femur can be | |
| salvaged. | |
| Intended use of the device | 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. | |
| 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 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. | |
| Substantial Equivalence | There are no changes in design, manufacturing, principle of operation, |
| indication, or intended use. | |
| The only change is the addition of Magnetic Resonance (MR) safety | |
| information in the Instructions for Use (IFU) and the update of language in the | |
| IFU as discussed in Performance Testing - Bench. | |
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO |
11
Image /page/11/Picture/0 description: The image is a logo for DePuy Synthes, a company that specializes in orthopedics. The logo features a red graphic to the left of the company name, which is written in gray. Below the company name, in smaller red font, is the text "THE ORTHOPAEDICS COMPANY of Johnson & Johnson."
12
Image /page/12/Picture/0 description: The image shows the logo for DePuy Synthes, a company that specializes in orthopedics and is part of Johnson & Johnson. The logo features a red abstract symbol on the left, followed by the company name "DePuy Synthes" in gray, bold letters. Below the company name, there is a tagline that reads "THE ORTHOPAEDICS COMPANY of Johnson & Johnson" in smaller letters.
THE PREDICATE DEVICE
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The following tests were performed (per FDA's Testing and Labeling Medical Devices for Safety in the Magnetic
Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff, October 2023) to determine Magnetic Resonance (MR) Safety:
ASTM F2503-23 - Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
ASTM F2182 -19E2 - Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants during Magnetic Resonance
ASTM F2052-21 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ASTM F2213-17 - Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
ASTM F2119-07 - Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
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
No clinical tests were conducted to demonstrate substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The subject DePuy LPS Limb Preservation System are substantially equivalent to the predicate LPS Limb Preservation System (K091453, K033959, K003182).
13
Image /page/13/Picture/0 description: The image is a logo for DePuy Synthes, a company that specializes in orthopedics and is part of Johnson & Johnson. The logo features a red abstract symbol on the left, followed by the company name "DePuy Synthes" in gray text. Below the company name, there is a tagline that reads "THE ORTHOPAEDICS COMPANY OF Johnson & Johnson" in smaller font size.
| Contact Details | |
|---|---|
| Applicant Name | DePuy Ireland UC |
| Applicant Address | Loughbeg, Ringaskiddy |
| Co. Cork Munster, IRELAND | |
| Applicant Contact Telephone | 574-400-6438 |
| Applicant Contact | Meagan Robles |
| Applicant Contact Email | Mroble10@its.jnj.com |
| Correspondent Name | DePuy Orthopaedics, Inc. |
| Correspondent Address | 700 Orthopaedic Drive Warsaw IN 46582 United States |
| Correspondent Contact | |
| Telephone | 574-400-6438 |
| Correspondent Contact | Meagan Robles |
| Correspondent Contact | |
| Mroble10@its.jnj.com | |
| Date prepared | December 21, 2023 |
| Name of device | |
| Trade or proprietary name | Sigma High Performance (HP) Partial Knee System |
| Common or usual name | Compartmental Knee Prosthesis System |
| Classification name | 21 CFR 888.3560 – Knee joint patellofemorotibial polymer/metal/polymer |
| semi-constrained cemented prosthesis | |
| 21 CFR 888.3530 - Knee joint femorotibial metal/polymer semi-constrained | |
| cemented prosthesis | |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | Class II - 21 CFR 888.3560; 21 CFR 888.3530 |
| Product Code(s) | NPJ: Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, |
| Cemented, Polymer/Metal/Polymer | |
| HRY: Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, | |
| Metal/Polymer | |
| KRR: Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, | |
| Metal/Polymer | |
| Legally marketed device(s) to | |
| which equivalence is claimed | Primary Predicate: K070267 - Sigma High Performing Unity Knee |
| Resurfacing | |
| Secondary Predicates: K070849 - DePuy GCK Femoral and Tibial | |
| Components: | |
| K061648 - DePuy Graduated Compartmental Knee (GCK) | |
| Reference Devices: | |
| K232303 – ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome | |
| Patella and Medialized Anatomic Patella with AFFIXIUMTM 3DP | |
| Technology | |
| K212746 & K230295 - ATTUNE Revision Cones | |
| Reason for 510(k) submission | In accordance with Section 510(k) of the Medical Device Amendments of |
| 1976 and Subpart E of Part 807, Title 21 of the Code of Federal Regulations, | |
| and as per the FDA Guidance, Bundling Multiple Devices or Multiple | |
| Indications in a Single Submission: Guidance for Industry and FDA Staff | |
| (June 2007), DePuy Ireland UC has compiled a Bundled Traditional 510(k) | |
| Premarket Notification to modify labeling to include updated MRI | |
| compatibility information for SigmaTM High Performance (HP) Partial Knee | |
| System (K070267, K070849, K061648). Updates include modernizing and standardizing the language of the Instructions for Use (IFU) and labels. | |
| Device description | The DePuy SIGMATM High Performance Partial Knee System is a single |
| compartmental knee prosthesis, composed of individually packaged femoral, | |
| and tibial components designed to be used in various combinations to replace | |
| the natural articular surfaces of the knee joint. | |
| The unicompartmental femoral components are Co-Cr-Mo metal implants. | |
| The metal backed tibial components are Co-Cr-Mo with polyethylene inserts. | |
| The all-polyethylene unicompartmental tibial component are manufactured | |
| from polyethylene. | |
| The unicompartmental femoral components are designed for individuals who | |
| require a higher than normal degree of flexion (up to 155°). | |
| Intended use of the device | The DePuy SIGMA High Performance Partial Knee System is intended to |
| provide increased patient mobility and reduced pain by replacing the | |
| articulating elements of a single compartment of a damaged knee joint in | |
| patients where there is evidence of sufficient sound bone to seat and support | |
| the components. | |
| Indications for use | The SIGMA High Performance Partial Knee System is indicated for single |
| compartmental knee replacement in skeletally mature individuals with | |
| osteoarthritis, post-traumatic arthritis of the tibiofemoral surfaces or a | |
| history of gout or pseudogout. All components are intended for | |
| CEMENTED USE ONLY. | |
| Substantial Equivalence | There are no changes in design, manufacturing, principle of operation, |
| indication, or intended use. | |
| The only change is the addition of Magnetic Resonance (MR) safety | |
| information in the Instructions for Use (IFU) and the update of language in | |
| the IFU as discussed in Performance Testing - Bench. |
14
Image /page/14/Picture/1 description: The image shows the logo for DePuy Synthes, "THE ORTHOPAEDICS COMPANY of Johnson & Johnson". The logo features a red symbol on the left, followed by the company name in gray. Below the company name, there is a tagline indicating that DePuy Synthes is the orthopedics company of Johnson & Johnson.
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K233980 Page 12 of 12
Image /page/15/Picture/1 description: The image shows the logo for DePuy Synthes, which is the orthopedics company of Johnson & Johnson. The logo features a red abstract symbol on the left, followed by the company name in gray, and the Johnson & Johnson affiliation in red. The DePuy Synthes logo is a well-known symbol in the medical device industry.
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The following tests were performed (per FDA's Testing and Labeling Medical Devices for Safety in the Magnetic
Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff, October 2023) to determine Magnetic Resonance (MR) Safety:
ASTM F2503-23 - Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
ASTM F2182 -19E2 - Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants during Magnetic Resonance
ASTM F2052-21 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ASTM F2213-17 - Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
ASTM F2119-07 - Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
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
No clinical tests were conducted to demonstrate substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The subject DePuy Sigma High Performance (HP) Partial Knee System are substantially equivalent to the predicate Sigma High Performance Unity Knee System (K070267, K070849, K061648).