(90 days)
No
The document describes a total knee replacement system, which is a physical implant. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The description explicitly states that the devices are types of "Total Knee Prosthesis" and are used "to replace the natural articular surface of the knee joint" for patients suffering from "severe pain and disability due to permanent structural damage" from various conditions. This indicates that their intended purpose is to treat or alleviate a medical condition by restoring a damaged anatomical part.
No
Explanation: The provided text describes various total knee replacement systems, which are prosthetic devices used to replace damaged knee joints. These devices are used for treatment and are not described as performing any diagnostic functions such as detecting, analyzing, or predicting a medical condition or disease.
No
The device description clearly states that the devices are composed of physical components such as femoral, tibial, and patellar implants, as well as modular stems, sleeves, and augments. These are hardware components, not software.
Based on the provided information, none of these devices are IVDs (In Vitro Diagnostics).
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The descriptions and intended uses clearly state that these devices are implants designed to replace or augment parts of the knee joint during surgery. They are physical components inserted into the body.
- Lack of Specimen Analysis: There is no mention of these devices being used to analyze biological specimens. Their function is mechanical and structural within the body.
Therefore, these devices fall under the category of implantable medical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
ATTUNE™ Revision Knee System
Candidates for total knee replacement include patients with
· A severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, or rheumatod arthritis
- · Moderate valgus, varus, or flexion deformities
- · Avascular necrosis of the femoral condyle
- · A previous unsuccessful knee replacement, osteotomy, or other knee procedure
ATTUNE Revision Knee System implants are designed for use in total knee arthroplasty for patients with:
- · Absence or loss of both cruciate ligaments
- · Moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgment of the surgeon
- · Bone loss that requires supplemental fixation in the clinical judgment of the surgeon
The porous-coated metaphyseal sleeves are intended for either cementless applications.
ANY NON POROUS-COATED COMPONENTS ARE INTENDED FOR CEMENTED USE ONLY.
DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves
The DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem components are intended for use with the PFC, PFC Sigma, Sigma TC3 Revision Knee, or S-ROM knee prosthesis in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. These devices are for cemented use only.
The DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem components are also intended for use with the DePuy LPS prosthesis for replacement of the mid-shaft portion of the femur, proximal, distal femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include: Malignant tumors (e.g., osteosarcomas, gian cell tumors, bone tumors) requiring extensive resection and replacement; patient conditions of noninflammatory degenerative join disease (NIDD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis, requiring extensive resection and replacement; revision for failed previous prosthesis cases requiring extensive resection and replacement. The LPS prosthesis is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.
The Universal Stem and the Universal Metaphyseal Sleeve components are intended for cemented use only.
DePuy Sigma PS Femoral Components and DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components
Candidates for total knee replacement include patients with a severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.
Total knee replacement may be considered for younger patients if, in 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 patients with multiple joint involvement for whom a gain in knee mobility may lead to significant improvement in the quality of their lives.
THE SIGMA C/R POROCOAT® FEMORAL COMPONENTS ARE INTENDED FOR CEMENTED OR CEMENTLESS USE AS THE FEMORAL COMPONENT OF A TOTAL KNEE REPLACEMENT SYSTEM.
THE SIGMA PS FEMORAL COMPONENTS ARE INTENDED FOR CEMENTED USE AS THE FEMORAL COMPONENTS OF A TOTAL KNEE REPLACEMENT SYSTEM.
S-ROM™ NOILES™ Rotating Hinge Knee
The S-ROM NOILES Rotating Hinge Knee is indicated in cases for cement use in patients who have reached skeletal maturity and for whom the surgeon has decided to resect both cruciate ligaments due to the following conditions:
- Severe instability, gross deformity and/or bone loss.
- Failure of a previous knee reconstruction procedure.
- Trauma or tumor resection.
- Absent or markedly insufficient collateral ligaments.
DePuy P.F.C.™ SIGMA™ Total Knee Prosthesis and DePuy SIGMA™ Total Knee Prosthesis
The DePuy SIGMA™ and P.F.C.™SIGMA™ Total Knee Prosthesis are intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention.
The DePuy SIGMA™ and P.F.C.™SIGMA™ Total Knee Prosthesis are intended for cement use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH, MBH
Device Description
ATTUNE™ Revision 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 consists of a metal tibial base without porous coating, and a locking polyethylene insert. Some metal components have modular stems, porous and non porous-coated sleeves and/or modular augments. The patella component is an all polyethylene design Total knee arthroplasty may include supplemental fixation through stems, sleeves, and/or modular augments where bone loss requires said fixation in the opinion of the surgeon. Total knee arthroplasty may also include more constrained bearing surfaces where necessary to provide stability where musculoligamentous supporting structures are insufficient.
DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves: A Total Knee Prosthesis System 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 tray with or without porous coating, and a polyethylene insert and locking components. Some metal components have modular stems, sleeves and/or modular wedges. The patella component may be of an all polyethylene design or may be a metal backed polyethylene component. The wobble bit is an instrument used to aid implant assembly.
DePuy Sigma PS Femoral Components and DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components: A SIGMA™ Total Knee System 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 tray with or without porous coating, and a polyethylene insert and locking components. Some metal components have modular stems, sleeves and/or modular wedges or augments. The patella component is an all polyethylene design.
S-ROM™ NOILES™ Rotating Hinge Knee System: The S-ROM NOILES Rotating Hinge Knee System is a tricompartmental total knee replacement for both primary and revision cases. The S-ROM NOILES Rotating Hinge Knee System includes the femoral component with hinge pin, the tibial plateau assembly, and the distal femoral augmentation blocks. Replacement bumpers for the femoral component assembly and replacement hinge bearings for the tibial plateau assembly are also available.
DePuy P.F.C.™ SIGMA™ Total Knee Prosthesis and DePuy SIGMA™ Total Knee Prosthesis: The DePuy SIGMA™ and P.F.C.™ SIGMA® Total Knee Prosthesis is a total knee prosthesis composed of individually packaged femoral, tibial base, tibial insert and patellar components designed to replace the natural articular surface of the knee joint or after a failed previous implant. Some femoral and tibial components can be used with modular stems, porous and non-porous coated sleeves and/or modular augments when supplemental fixation is required in the judgement of the surgeon. The natural patella may or may not be resurfaced.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
Indicated Patient Age Range
Candidates for total knee replacement may include younger patients if the surgeon determines that the indication outweighs the risks and limited demands can be assured.
ATTUNE Revision Knee System: Not Specified
DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem Components: Not Specified
S-ROM™ NOILES™ Rotating Hinge Knee: Skeletally mature patients
DePuy Sigma PS Femoral Components and DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components: Not Specified
DePuy P.F.C.™ SIGMA™ Total Knee Prosthesis and DePuy SIGMA™ Total Knee Prosthesis: Not Specified
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 (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.
No clinical tests were conducted to demonstrate substantial equivalence.
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.
ATTUNE™ Revision Knee System: K160700
DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves: K063633
DePuy Sigma PS Femoral Components: K073529
DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components: K062654
S-ROM™ NOILES™ Rotating Hinge Knee System: K896048, K936037, K924940, K905810, K870730
DePuy P.F.C.™ SIGMA™ Total Knee Prosthesis: K060515, K984158, K971189, K971652, K963117, K961685, K950010, K952830, K943462, K923807, K884796, K882234
DePuy SIGMA™ Total Knee Prosthesis: K040166, K033272, K032151
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.
ATTUNE™ Revision Knee System: K232303, K212746 & K230295, K233980
DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves: K232303, K212746 & K230295, K233980
DePuy Sigma PS Femoral Components and DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components: K232303, K212746 & K230295, K233980
S-ROM™ NOILES™ Rotating Hinge Knee System: K232303, K212746 & K230295, K233980
DePuy P.F.C.™ SIGMA™ Total Knee Prosthesis and DePuy SIGMA™ Total Knee Prosthesis: K232303, K212746 & K230295, K233980
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, 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.
July 11, 2024
DePuy Ireland UC Meagan Robles Regulatory Affairs Project Leader Loughbeg Ringaskiddy, Co. Cork Munster Ireland
Re: K241000
Trade/Device Name: ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM™ NOILESTM Rotating Hinge Knee System; DePuy P.F.C. TM SIGMATM Total Knee Prosthesis; DePuy SIGMA™ Total Knee Prosthesis; 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: April 11, 2024 Received: April 12, 2024
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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 Quality System (QS) 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,
Image /page/2/Picture/3 description: The image shows the name "Lixin Liu-S" in a simple, sans-serif font. The text is black against a white background. There is a faint, light blue watermark behind the text, adding a subtle visual element to the composition. The overall design is clean and straightforward, focusing on the clarity and legibility of the name.
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
510(k) Number (if known) K241000
Device Name
ATTUNE Revision Knee System: DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM NOILES Rotating Hinge Knee System;DePuy P.F.C. SIGMA Total Knee Prosthesis;DePuy SIGMA TM Total Knee Prosthesis
Indications for Use (Describe)
ATTUNE™ Revision Knee System
Candidates for total knee replacement include patients with
· A severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, or rheumatod arthritis
- · Moderate valgus, varus, or flexion deformities
- · Avascular necrosis of the femoral condyle
- · A previous unsuccessful knee replacement, osteotomy, or other knee procedure
ATTUNE Revision Knee System implants are designed for use in total knee arthroplasty for patients with:
- · Absence or loss of both cruciate ligaments
· Moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgment of the surgeon
• Bone loss that requires supplemental fixation in the clinical judgment of the surgeon
The porous-coated metaphyseal sleeves are intended for either cementless applications.
ANY NON POROUS-COATED COMPONENTS ARE INTENDED FOR CEMENTED USE ONLY.
DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves The DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem components are intended for use with the PFC, PFC Sigma, Sigma TC3 Revision Knee, or S-ROM knee prosthesis in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. These devices are for cemented use only.
The DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem components are also intended for use with the DePuy LPS prosthesis for replacement of the mid-shaft portion of the femur, proximal, distal femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include: Malignant tumors (e.g., osteosarcomas, gian cell tumors, bone tumors) requiring extensive resection and replacement; patient conditions of noninflammatory degenerative join disease (NIDD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis, requiring extensive resection and replacement; revision for failed previous prosthesis cases requiring extensive resection and replacement. The LPS prosthesis is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.
The Universal Stem and the Universal Metaphyseal Sleeve components are intended for cemented use only.
DePuy Sigma PS Femoral Components and DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components Candidates for total knee replacement include patients with a severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.
Total knee replacement may be considered for younger patients if, in the surgeon, an unequivocal indication for total knee replacement outweighs the risks associated with the age of the patient, and if limited demands
4
regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom a gain in knee mobility may lead to significant improvement in the quality of their lives.
THE SIGMA C/R POROCOAT® FEMORAL COMPONENTS ARE INTENDED FOR CEMENTED OR CEMENTLESS USE AS THE FEMORAL COMPONENT OF A TOTAL KNEE REPLACEMENT SYSTEM.
THE SIGMA PS FEMORAL COMPONENTS ARE INTENDED FOR CEMENTED USE AS THE FEMORAL COMPONENTS OF A TOTAL KNEE REPLACEMENT SYSTEM.
S-ROM™ NOILESTM Rotating Hinge Knee
The S-ROM NOILES Rotating Hinge Knee is indicated in cases for cement use in patients who have reached skeletal maturity and for whom the surgeon has decided to resect both cruciate ligaments due to the following conditions:
-
- Severe instability, gross deformity and/or bone loss.
-
- Failure of a previous knee reconstruction procedure.
-
- Trauma or tumor resection.
-
- Absent or markedly insufficient collateral ligaments.
DePuy P.F.C. TM SIGMA™ Total Knee Prosthesis and DePuy SIGMA™ Total Knee Prosthesis The DePuy SIGMA™ and P.F.C. ™SIGMA™ Total Knee Prosthesis are intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention.
The DePuy SIGMA™ and P.F.C. ™SIGMA™ Total Knee Prosthesis are intended for cement use only.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
Image /page/5/Picture/1 description: The image is a logo for DePuy Synthes, a company that specializes in orthopedics. The logo features a red abstract 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.
Bundled Traditional 510(k)
ATTUNE™ Revision Knee System, DePuy Knee Prosthesis System- Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves, DePuy Sigma PS Femoral Components. DePuy Sigma Cruciate Retaining (C/A) Porcorati Femoral Components.
DePuy Stemperat Femorat Femoral Femoral Components.
Provinsion
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 & Correspondent | |
| Contact Telephone | 574-400-6438 |
| Applicant & Correspondent | |
| Contact | Meagan Robles |
| Applicant & Correspondent | |
| Contact Email | Mroble10@its.jnj.com |
| Correspondent Name | DePuy Orthopaedics, Inc. |
| Correspondent Address | 700 Orthopaedic Drive Warsaw IN 46582 United States |
| Date prepared | April 11th, 2024 |
| Name of device | |
| Trade or proprietary name | ATTUNE TM Revision 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 | |
| 21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous- | |
| coated uncemented prosthesis | |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | Class II - 21 CFR 888.3560, 21 CFR 888.3565 |
| 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 | |
| Legally marketed device(s) to | |
| which equivalence is claimed | Primary Predicate: |
| K160700 – ATTUNE TM Revision Knee 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 | |
| K233980- ATTUNE Total Knee System, ATTUNE Knee System Cementless, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System | |
| 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 ATTUNETM Revision Knee System (K160700). 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 consists of a metal tibial base without porous coating, and a locking polyethylene insert. Some metal components have modular stems, porous and non porous-coated sleeves and/or modular augments. The patella component is an all polyethylene design |
| Total knee arthroplasty may include supplemental fixation through stems, sleeves, and/or modular augments where bone loss requires said fixation in the opinion of the surgeon. Total knee arthroplasty may also include more constrained bearing surfaces where necessary to provide stability where musculoligamentous supporting structures are insufficient. | |
| Intended use of the device | Total knee arthroplasty is a total joint replacement surgery designed 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. |
| 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, or rheumatoid arthritis Moderate valgus, varus, or flexion deformities Avascular necrosis of the femoral condyle A previous unsuccessful knee replacement, osteotomy, or other knee procedure ATTUNE Revision Knee System implants are designed for use in total knee arthroplasty for patients with: Absence or loss of both cruciate ligaments Moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgment of the surgeon Bone loss that requires supplemental fixation in the clinical judgment of the surgeon The porous-coated metaphyseal sleeves are intended for either cemented or cementless applications. ANY NON POROUS-COATED 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. |
6
K241000 (Page 2 of 17)
Image /page/6/Picture/1 description: The image is a 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" in smaller gray font, followed by "of Johnson & Johnson" in red font.
7
K241000 (Page 3 of 17)
Image /page/7/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 abstract symbol resembling a stylized spine or interconnected network. Next to the symbol, the company name "DePuy Synthes" is written in gray, with "DePuy" being larger and bolder than "Synthes". Below the company name, there is a smaller line of text that reads "THE ORTHOPAEDICS COMPANY of Johnson & Johnson".
Bundled Traditional 510(k) M Revision Knee System. DePuy Knee Prosthesis System- Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves. DePuv Sigma PS Femoral Components. DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components, S-ROM TM OILES Rotating Hinge Knee System. DePuv P.F.C.1 M SigmaTM Knee System. SigmaTM Knee System
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
8
Image /page/8/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 spine or interconnected network on the left. To the right of the symbol, the company name "DePuy Synthes" is displayed in a bold, gray font. Below the company name, there is a tagline that reads "THE ORTHOPAEDICS COMPANY of Johnson & Johnson" in a smaller font size.
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 Revision Knee System are substantially equivalent to the predicate ATTUNE Revision Knee System (K160700).
| Contact Details | |
|---|---|
| Applicant Name | DePuy Ireland UC |
| Applicant Address | Loughbeg, Ringaskiddy |
| Co. Cork Munster, IRELAND | |
| Applicant & Correspondent | |
| Contact Telephone | 574-400-6438 |
| Applicant & Correspondent | |
| Contact | Meagan Robles |
| Applicant & Correspondent | |
| Contact Email | Mroble10@its.jnj.com |
| Correspondent Name | DePuy Orthopaedics, Inc. |
| Correspondent Address | 700 Orthopaedic Drive Warsaw IN 46582 United States |
| Date prepared | April 11th, 2024 |
| Name of device | |
| Trade or proprietary name | DePuy Knee Prosthesis System Universal Stem Extensions and Universal |
| Femoral Metaphyseal Sleeves | |
| Common or usual name | Tricompartmental Knee 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 | |
| Legally marketed device(s) to | |
| which equivalence is claimed | Primary Predicate: K063633 - DePuy Knee Prosthesis System Universal |
| Stem Extensions and Universal Femoral Metaphyseal Sleeves | |
| 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 | |
| K233980- ATTUNE Total Knee System, ATTUNE Knee System | |
| Cementless, LPS Limb Preservation System, Sigma High Performance (HP) | |
| Partial Knee System | |
| 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 Knee Prosthesis System Universal Stem | |
| Extensions and Universal Femoral Metaphyseal Sleeves (K063633). Updates | |
| include modernizing and standardizing the language of the Instructions for Use | |
| (IFU) and labels. | |
| Device description | A Total Knee Prosthesis System 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 tray with or without | |
| porous coating, and a polyethylene insert and locking components. Some | |
| metal components have modular stems, sleeves and/or modular wedges. The | |
| patella component may be of an all polyethylene design or may be a metal | |
| backed polyethylene component. The wobble bit is an instrument used to aid | |
| implant assembly. | |
| 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. | |
| Indications for use | The DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem |
| components are intended for use with the PFC, PFC Sigma, Sigma TC3 | |
| Revision Knee, or S-ROM knee prosthesis in total knee replacement surgery | |
| for patients suffering from severe pain and disability due to permanent | |
| structural damage resulting from rheumatoid arthritis, osteoarthritis, post- | |
| traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior | |
| surgical intervention. These devices are for cemented use only. |
The DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem
components are also intended for use with the DePuy LPS prosthesis for
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, gian cell tumors,
bone tumors) requiring extensive resection and replacement; patient
conditions of noninflammatory degenerative join disease (NIDJD), e.g.
avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g.
rheumatoid arthritis, requiring extensive resection and replacement; revision
for failed previous prosthesis cases requiring extensive resection and
replacement. The LPS prosthesis is also intended for use in bone loss post-
infection, where the surgeon has elected to excise the bone and replacement
is required.
The Universal Stem and the Universal Metaphyseal Sleeve 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. |
9
Image /page/9/Picture/0 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 text. Below the company name, there is a tagline that reads "THE ORTHOPAEDICS COMPANY of Johnson & Johnson" in smaller text.
Bundled Traditional 510(k)
ATTUNE™ Revision Knee System, DePuy Knee Prosthesis System- Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves, Simorsia Stein Latensianing Chiners Strenoral Compral Comprehensiscensions
Simbersia Steraining Priy Sema PS Femoral Compositem Sistems
DePuy Sigma Cruciate Recaramia TMLES R
Г
10
Image /page/10/Picture/0 description: The image shows the logo for DePuy Synthes, which is the orthopaedics company of Johnson & Johnson. The logo features a red abstract symbol on the left, followed by the company name in gray text. Below the company name, there is a tagline indicating that it is the orthopaedics company of Johnson & Johnson.
Bundled Traditional 510(k) ATTUNETM Revision Knee System, DePuy Knee Prosthesis System- Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves, DePuy Sigma PS Femoral Components. DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components, S-ROM TM NOILES Rotating Hinge Knee System. DePuy P.F.C.TM SigmaTM Knee System. Sigma™ Knee System
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
11
Image /page/11/Picture/1 description: The image shows the logo for DePuy Synthes, which is 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 font, it says "THE ORTHOPAEDICS COMPANY OF" followed by the Johnson & Johnson logo in red.
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 DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves are substantially equivalent to the predicate DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves (K063633).
| Contact Details | |
|---|---|
| Applicant Name | DePuy Ireland UC |
| Applicant Address | Loughbeg, Ringaskiddy |
| Co. Cork Munster, IRELAND | |
| Applicant & Correspondent | |
| Contact Telephone | 574-400-6438 |
| Applicant & Correspondent | |
| Contact | Meagan Robles |
| Applicant & Correspondent | |
| Contact Email | Mroble10@its.jnj.com |
| Correspondent Name | DePuy Orthopaedics, Inc. |
| Correspondent Address | 700 Orthopaedic Drive Warsaw IN 46582 United States |
| Date prepared | April 11th, 2024 |
| Name of device | |
| Trade or proprietary name | DePuy Sigma PS Femoral Components |
| DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components | |
| Common or usual name | Total Knee System |
| Classification name | 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 888.3560; 21 CFR 888.3565 |
| 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 | |
| Legally marketed device(s) to | |
| which equivalence is claimed | Primary Predicate for DePuy Sigma PS Femoral Components: |
| K073529 – DePuy Sigma PS Femoral Components | |
| Primary Predicate for DePuy Sigma Cruciate Retaining (C/R) Porocoat | |
| Femoral Components: | |
| K062654 - DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral | |
| Components | |
| 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 | |
| K233980- ATTUNE Total Knee System, ATTUNE Knee System | |
| Cementless, LPS Limb Preservation System, Sigma High Performance (HP) | |
| Partial Knee System | |
| 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 Sigma PS Femoral Components | |
| (K073529) and DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral | |
| Components (K062654). | |
| therefore, have been combined within the same Instructions for Use (IFU). | |
| Additional, updates include modernizing and standardizing the language of the | |
| IFU and labels. | |
| Device description | A SIGMA™ |
| Total Knee System 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 tray with or without | |
| porous coating, and a polyethylene insert and locking components. Some | |
| metal components have modular stems, sleeves and/or modular wedges or | |
| augments. The patella component is 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. | |
| 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. | |
| 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 patients with multiple joint involvement for | |
| whom a gain in knee mobility may lead to significant improvement in the | |
| quality of their lives. | |
| THE SIGMA C/R POROCOAT® FEMORAL COMPONENTS ARE | |
| INTENDED FOR CEMENTED OR CEMENTLESS USE AS THE | |
| FEMORAL COMPONENT OF A TOTAL KNEE REPLACEMENT | |
| SYSTEM. | |
| THE SIGMA PS FEMORAL COMPONENTS ARE INTENDED FOR | |
| CEMENTED USE AS THE FEMORAL COMPONENTS OF A TOTAL | |
| KNEE REPLACEMENT SYSTEM. | |
| Substantial Equivalence | There are no changes in design, manufacturing, principle of operation, |
| indication, or intended use. |
12
Image /page/12/Picture/1 description: The image shows the DePuy Synthes logo. The logo features a red abstract symbol on the left, followed by the company name "DePuy Synthes" in a bold, sans-serif font. Below the company name, there is a tagline that reads "THE ORTHOPAEDICS COMPANY of Johnson & Johnson" in a smaller font size.
13
Image /page/13/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 spine or interconnected network on the left. To the right of the symbol, the words "DePuy Synthes" are written in a clear, sans-serif font. Below the company name, there is a tagline that reads "THE ORTHOPAEDICS COMPANY of Johnson & Johnson."
14
Image /page/14/Picture/0 description: The image shows the DePuy Synthes logo. The logo features a red abstract symbol on the left, followed by the text "DePuy Synthes" in gray. Below the text, there is a smaller line of text that reads "THE ORTHOPAEDICS COMPANY OF Johnson&Johnson" in a smaller font size, with "Johnson&Johnson" in red.
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 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 PS Femoral Components and DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components are substantially equivalent to the predicate DePuy Sigma PS Femoral Components (K073529) and DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components (K062654).
15
Image /page/15/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 spine or interconnected network on the left. To the right of the symbol, the company name "DePuy Synthes" is written in a bold, sans-serif font. Below the company name, there is a tagline that reads "THE ORTHOPAEDICS COMPANY of Johnson & Johnson" in a smaller font size.
T
| Contact Details | |
|---|---|
| Applicant Name | DePuy Ireland UC |
| Applicant Address | Loughbeg, Ringaskiddy |
| Co. Cork Munster, IRELAND | |
| Applicant & Correspondent Contact Telephone | 574-400-6438 |
| Applicant & Correspondent Contact | Meagan Robles |
| Applicant & Correspondent Contact Email | Mroble10@its.jnj.com |
| Correspondent Name | DePuy Orthopaedics, Inc. |
| Correspondent Address | 700 Orthopaedic Drive Warsaw IN 46582 United States |
| Date prepared | April 11th, 2024 |
| Name of device | |
| Trade or proprietary name | S-ROMTM NOILESTM Rotating Hinge Knee System |
| Common or usual name | Tricompartmental Knee System |
| 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 | |
| Legally marketed device(s) to | |
| which equivalence is claimed | Primary Predicate: K896048- S-ROM/Noiles Mark 3 |
| Secondary Predicates: | |
| K936037 - S-ROM NOILES Cruciate Retaining Knee | |
| K924940- Femoral & Tibial Augment Block, | |
| K905810- NoilesTM Total Knee Prosthesis, Modification, | |
| K870730- Noiles Total Knee Prosthesis |
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
K233980- ATTUNE Total Knee System, ATTUNE Knee System
Cementless, LPS Limb Preservation System, Sigma High Performance (HP)
Partial Knee System | |
| 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 S-ROMTM NOILESTTM Rotating Hinge
Knee System (K936037, K924940, K905810, K896048, K870730). Updates
include modernizing and standardizing the language of the Instructions for Use
(IFU) and labels. |
| Device description | The S-ROM NOILES Rotating Hinge Knee System is a tricompartmental
total knee replacement for both primary and revision cases. The S-ROM
NOILES Rotating Hinge Knee System includes the femoral component with
hinge pin, the tibial plateau assembly, and the distal femoral augmentation
blocks. Replacement bumpers for the femoral component assembly and
replacement hinge bearings for the tibial plateau assembly are also available. |
| Intended use of the device | The S-ROM NOILES Rotating Knee Hinge System is intended to provide a
functional articulating knee joint in skeletally mature patients with a severely
painful knee and impaired knee function and/or after a failed previous
implant. |
| Indications for use | The S-ROM NOILES Rotating Hinge Knee is indicated in cases for cement
use in patients who have reached skeletal maturity and for whom the
surgeon has decided to resect both cruciate ligaments due to the following
conditions:
- Severe instability, gross deformity and/or bone loss.
- Failure of a previous knee reconstruction procedure.
- Trauma or tumor resection.
- Absent or markedly insufficient collateral ligaments. |
| Substantial Equivalence | There are no changes in design, manufacturing, principle of operation,
indication, or intended use. |
16
K241000 (Page 12 of 17)
Image /page/16/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 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 font size.
17
Image /page/17/Picture/1 description: The image shows the logo for DePuy Synthes, a company that specializes in orthopedics. The logo features a red abstract symbol on the left, followed by the company name in gray, "DePuy Synthes". Below the company name, in smaller font, it says "THE ORTHOPAEDICS COMPANY of Johnson & Johnson".
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 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 S-ROM NOILES Rotating Hinge Knee are substantially equivalent to the predicate DePuy S-ROM™ NOILES™ Rotating Hinge Knee System (K896048, K936037, K924940, K905810, K870730).
| Contact Details | |
|---|---|
| Applicant Name | DePuy Ireland UC |
| Applicant Address | Loughbeg, Ringaskiddy |
| Co. Cork Munster, IRELAND |
18
Image /page/18/Picture/0 description: The image shows the logo for DePuy Synthes, a company that specializes in orthopedics. The logo features a red abstract symbol on the left, followed by the company name in gray, "DePuy Synthes". Below the company name, in smaller red font, is the tagline "THE ORTHOPAEDICS COMPANY of Johnson & Johnson".
Bundled Traditional 510(k)
ATTUNE™ Revision Knee System, DePuy Knee Prosthesis System- Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves, Simorsia Stein Latensianing Chiners Strenoral Compral Comprehensiscensions
Simbersia Steraining Priy Sema PS Femoral Compositem Sistems
DePuy Sigma Cruciate Recaramia TMLES R
| Applicant & Correspondent
| Contact Telephone | 574-400-6438 |
|---|---|
| Applicant & Correspondent | |
| Contact | Meagan Robles |
| Applicant & Correspondent | |
| Contact Email | Mroble10@its.jnj.com |
| Correspondent Name | DePuy Orthopaedics, Inc. |
| Correspondent Address | 700 Orthopaedic Drive Warsaw IN 46582 United States |
| Date prepared | April 11th, 2024 |
| Name of device | |
| Trade or proprietary name | DePuy P.F.C. TM SIGMATM Total Knee Prosthesis |
| DePuy SIGMATM Total Knee Prosthesis | |
| Common or usual name | Tricompartmental Knee 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 | |
| Legally marketed device(s) to | |
| which equivalence is claimed | DePuy P.F.C. TM SIGMATM Total Knee Prosthesis |
| Primary Predicate for DePuy P.F.C. TM SIGMATM Total Knee | |
| Prosthesis: | |
| K060515- DePuy P.F.C. SIGMA Knee Prosthesis | |
| Secondary Predicates for DePuy P.F.C. TM SIGMATM Total Knee | |
| System: | |
| K984158- DePuy P.F.C. Modular Plus Offset Tibial Trays, | |
| K971189- DePuy P.F.C. TM SIGMATM Knee System (SIZE 1.5) , | |
| K971652- PFC Sigma Knee System Inset Patella | |
| K963117- P.F.C. Sigma Knee System (Stabilized Plus) | |
| K950010- Darwin Knee System (Cruciate Substituting) Porous coated and | |
| Non-Porous Coated | |
| K952830- Darwin Knee System | |
| K943462- Darwin Knee System | |
| K923807- P.F.C. Modular Total Knee System, Modular Plus | |
| K884796- P.F.C. Modular Knee | |
| K882234- Johnson & Johnson Modular Total Knee Prosthesis | |
| DePuy Sigma Total Knee Prosthesis | |
| Primary Predicate for DePuy Sigma Total Knee Prosthesis: | |
| K040166 - DePuy Sigma XLK Tibial Inserts | |
| Secondary Predicates for DePuy Sigma Total Knee Prosthesis: | |
| K033272 - DePuy Sigma Tibial Inserts | |
| K032151 -DePuy Sigma Co-Cr Tibial Trays | |
| 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 | |
| K233980- ATTUNE Total Knee System, ATTUNE Knee System | |
| Cementless, LPS Limb Preservation System, Sigma High Performance (HP) | |
| Partial Knee System | |
| 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 P.F.C. ™ SIGMA™ Total Knee | |
| Prosthesis (K060515, K984158, K971189, K971652, K963117, K961685, | |
| K950010, K952830, K943462, K923807, K884796, K882234) and DePuy | |
| SIGMA™ Total Knee Prosthesis (K040166, K033272, K032151). Updates | |
| include modernizing and standardizing the language of the Instructions for Use | |
| (IFU) and labels. |
19
Image /page/19/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 tagline that identifies DePuy Synthes as the orthopedics company of Johnson & Johnson. The logo is clean and professional, and it is likely used on the company's website, marketing materials, and products.
20
Image /page/20/Picture/0 description: The image is a logo for DePuy Synthes, a company that specializes in orthopedics. The logo features a red abstract symbol on the left, followed by the company name in gray, "DePuy Synthes". Below the company name, in smaller gray text, it says "THE ORTHOPAEDICS COMPANY OF", followed by the Johnson & Johnson logo in red.
| Device description | The DePuy SIGMA™ and P.F.C.™ SIGMA® Total Knee Prosthesis is a total
knee prosthesis composed of individually packaged femoral, tibial base, tibial
insert and patellar components designed to replace the natural articular surface
of the knee joint or after a failed previous implant. Some femoral and tibial
components can be used with modular stems, porous and non-porous coated
sleeves and/or modular augments when supplemental fixation is required in
the judgement of the surgeon. The natural patella may or may not be
resurfaced. |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use of the device | The DePuy SIGMA and P.F.C SIGMA Total Knee Prosthesis is intended to
replace articulating elements of a damaged knee joint where there is evidence
of sufficient sound bone to seat and support the components. |
| Indications for use | The DePuy SIGMA™ and P.F.C.™SIGMA™ Total Knee Prosthesis are
intended for use in total knee replacement surgery for patients suffering from
severe pain and disability due to permanent structural damage resulting from
rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen
disorders, pseudogout, trauma or failed prior surgical intervention.
The DePuy SIGMA™ and P.F.C.™SIGMA™ Total Knee Prosthesis are
intended for cement 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. |
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:
21
Image /page/21/Picture/1 description: The image shows the logo for DePuy Synthes, which is 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 font, it says "THE ORTHOPAEDICS COMPANY OF" followed by the Johnson & Johnson logo in red.
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 P.F.C. ™ SIGMA™ Total Knee Prosthesis and DePuy SIGMA™ Total Knee Prosthesis are substantially equivalent to the predicate DePuy P.F.C. TM SIGMATM Total Knee Prosthesis (K060515, K984158, K971189, K971652, K963117, K961685, K950010, K952830, K943462, K923807, K884796, K882234) and DePuy SIGMA™ Total Knee Prosthesis (K040166, K033272, K032151).