(58 days)
No
The device description and performance studies focus on the mechanical properties and materials of the knee implant components. There is no mention of AI, ML, image processing, or data analysis related to patient data or surgical planning.
Yes
The device is described as a "total knee replacement system" intended for patients with a "severely painful and/or severely disabled joint." Its purpose is to replace the natural articular surface of the knee joint, which indicates a direct intervention to treat a medical condition.
No
The device is a total knee replacement system, which is a therapeutic implant, not a diagnostic tool. Its purpose is to replace a diseased or damaged knee joint.
No
The device description clearly outlines physical components (femoral, tibial, and patellar components made of metal and polyethylene) that are implanted in the body. This is a hardware medical device, not software-only.
Based on the provided information, the DePuy Attune Total Knee System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to replace a severely painful and/or disabled knee joint. This is a surgical implant, not a device used to examine specimens derived from the human body.
- Device Description: The device is described as a total knee prosthesis composed of physical components (femoral, tibial, and patellar) designed to replace the natural joint surfaces. This is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. The DePuy Attune Total Knee System is a medical device used for surgical implantation to restore joint function.
N/A
Intended Use / Indications for Use
The DePuy Attune Total Knee System is intended for use as a total knee replacement system. Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, posttraumatic arthritis, rheumatoid arthritis, or a failed previous implant.
Product codes (comma separated list FDA assigned to the subject device)
OIY, JWH
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.
Femoral Components
The ATTUNE CR and PS Femoral Components are a metal femoral knee component intended for cemented use. The Femoral Component may be used with the native patella or a resurfaced patella. The congruency is variable and optimized throughout the range of motion.
Fixed Bearing (FB) Tibial Base
The ATTUNE FB Tibial Base is designed to utilize a central universal locking mechanism intended for cemented use. The tibial base incorporates a stem and keel to provide additional stability and recessed cement pockets for enhanced cement fixation. The tibial base fixation surface is textured.
Fixed Bearing (FB) Tibial Insert
The ATTUNE CR and PS FB Tibial Insert is a polyethylene component. The FB Tibial Inserts are secured to the metal FB Tibial Base.
Patella Components
The ATTUNE Medialized Dome Patella and Medialized Anatomic Patella is a polyethylene component. The patellar components are cemented to the native patella and articulate with the trochlear groove and condyles of the Femoral Component.
The subject Attune medialized dome and medialized anatomic patellae are available in sizes 29, 32, 35, 38, and 41mm. The fixation surface incorporates 3 pegs to provide stability and recessed cement pockets for enhanced cement fixation. The patella components are manufactured from AOX ultra high molecular weight polyethylene conforming to ASTM F648. The articular surface is offset medially proportional to the size of the component.
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
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests and evaluations were performed to determine impact of splitting of the sterilization dose from a single, high doses through a combination of crosslinking and terminal sterilization:
- ISO 14243-2:2016: Wear of total knee-joint prostheses – Part 2: Methods of measurement
- ASTM F1877-05: Standard Practice for Characterization of Particles
- ASTM F277-16: Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
- ASTM F648-21: Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
- . ANSI AAMI ISO 11137-1:2006/(R)2015: Sterilization of health care products – Radiation – Part 1:Requirements for development validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2019)]
- ASTM E2023-11: Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities
- . ASTM F2003-02 (Reapproved 2015): Standard Practice for Accelerated Aging of Ultra-High-Molecular-Weight Polyethylene after Gamma Irradiation in Air
- ASTM D1505-18: Standard Test Method for Density of Plastics by the Density-Gradient Technique
- ASTM F625-10 (Reapproved 2016): Standard Test Method for Measurement of Enthalpy of Fusion Percent Crystallinity and Melting Point of Ultra-High-Molecular-Weight Polyethylene by Means of Differential Scanning Calorimetry
- . ASTM F2102-17: Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
- ASTM F281-19: Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
- ASTM D638-14 Standard Test Method for Tensile Properties of Plastics
No clinical tests were conducted to demonstrate substantial equivalence.
Based on the intended use, indications for use, and technological characteristics supported by performance testing, it can be concluded that the subject DePuy Attune™ Total Knee System are substantially equivalent to the predicate DePuy Attune™ Total Knee System (K103756).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
November 1, 2024
DePuy Orthopedics Inc % Susan Mullane Associate Director, Regulatory Affairs DePuy Ireland UC Loughbeg Ringaskiddy, Cork P43 ED82 Ireland
Re: K242665
Trade/Device Name: DePuv ATTUNE™ Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: OIY, JWH Dated: August 11, 2024 Received: September 4, 2024
Dear Susan Mullane:
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.
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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 (OS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 mediation-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
2
the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/2/Picture/3 description: The image shows the name "Lixin Liu-S" in a simple, sans-serif font. The text is black and appears to be centered on a white background. The letters are evenly spaced and the name is easy to read. The overall impression is clean and professional.
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) K242665
Device Name DePuy ATTUNETM Total Knee System
Indications for Use (Describe)
The DePuy Attune Total Knee System is intended for use as a total knee replacement system. Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, posttraumatic arthritis, rheumatoid arthritis, or a failed previous implant.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CER 801 Subpart C) |
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Image /page/4/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 gray. Below the company name, there is a tagline that reads "THE ORTHOPAEDICS COMPANY OF Johnson & Johnson" in a smaller font size.
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 | +353 21 4914000 |
| Applicant & Correspondent | |
| Contact | Susan Mullane |
| Applicant & Correspondent | |
| Contact Email | smullane@its.jnj.com |
| Correspondent Name | DePuy Orthopaedics, Inc. |
| Correspondent Address | 700 Orthopaedic Drive, |
| Warsaw, IN 46582 | |
| United States | |
| Date prepared | July 30, 2024 |
| Name of device | |
| Trade or proprietary name | DePuy 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) | OIY: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, |
| Polymer + Additive/Metal/Polymer + Additive |
JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented,
Polymer/Metal/Polymer |
| Legally marketed device(s)
to which equivalence is
claimed | Primary Predicate: |
| | K103756 – DePuy Attune Total Knee System |
| | Additional Predicate: |
| | K101433 – DePuy Attune Knee System |
| | Reference Device: |
| | K233980 – DePuy Attune Total Knee System |
| | K201347 - DePuy ATTUNE™ Total 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 Format for Traditional and Abbreviated 510(k)s:
Guidance for Industry and Food and Drug Administration Staff (2019), DePuy
Ireland UC has compiled a Traditional 510(k) Premarket Notification to modify
the existing sterilization dosing method for a subset of the DePuy Knee
portfolio of implants; specifically, components of the additional predicate
ATTUNE Total Knee System (K101433): the Attune Medialized Anatomic and
Medialized Dome Patellar components (K103756). Updates include the
splitting of the sterilization dose from a single, high dose to two doses
through a combination of crosslinking and terminal sterilization. |
| 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. |
| | Femoral Components |
| | The ATTUNE CR and PS Femoral Components are a metal femoral knee |
| | component intended for cemented use. The Femoral Component may be |
| | used with the native patella or a resurfaced patella. The congruency is |
| | variable and optimized throughout the range of motion. |
| | Fixed Bearing (FB) Tibial Base |
| | The ATTUNE FB Tibial Base is designed to utilize a central universal locking |
| | mechanism intended for cemented use. The tibial base incorporates a stem |
| | and keel to provide additional stability and recessed cement pockets for |
| | enhanced cement fixation. The tibial base fixation surface is textured. |
| | Fixed Bearing (FB) Tibial Insert |
| | The ATTUNE CR and PS FB Tibial Insert is a polyethylene component. The FB |
| | Tibial Inserts are secured to the metal FB Tibial Base. |
| | Patella Components
The ATTUNE Medialized Dome Patella and Medialized Anatomic Patella is a
polyethylene component. The patellar components are cemented to the
native patella and articulate with the trochlear groove and condyles of the
Femoral Component. |
| | The subject Attune medialized dome and medialized anatomic patellae are
available in sizes 29, 32, 35, 38, and 41mm. The fixation surface incorporates
3 pegs to provide stability and recessed cement pockets for enhanced cement
fixation. The patella components are manufactured from AOX ultra high
molecular weight polyethylene conforming to ASTM F648. The articular
surface is offset medially proportional to the size of the component. |
| 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 Attune Total Knee System is intended for use as a 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, rheumatoid arthritis, or a failed previous
implant. |
| Substantial equivalence | The splitting of the sterilization dose into two doses (crosslinking of raw
material and terminal sterilization of finished good) does not impact product
intended use, performance, safety, effectiveness, biocompatibility, standards
compliance, or labeling set forth by the predicate device. |
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Image /page/5/Picture/1 description: The image shows the logo for DePuy Synthes, "THE ORTHOPAEDICS COMPANY OF Johnson & Johnson". The logo has a red symbol on the left, followed by the company name in gray. Below the company name is the tagline in smaller letters.
6
Image /page/6/Picture/0 description: The image shows the DePuy Synthes logo. The logo consists of a red abstract symbol on the left, followed by the words "DePuy Synthes" in gray. Below the words, there is a tagline that reads "THE ORTHOPAEDICS COMPANY OF Johnson & Johnson" in a smaller font size. The Johnson & Johnson part of the tagline is in red.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
Below is a summary of the technological characteristics of the subject device compared to the predicate device, as support by performance testing:
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Image /page/7/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, "DePuy Synthes". Below the company name, in smaller red font, is the text "THE ORTHOPAEDICS COMPANY OF Johnson & Johnson".
| Characteristic | Subject Device:
DePuy
Attune™ Total
Knee System
(K242665) | Primary
Predicate:
DePuy
Attune Total
Knee System
(K103756) | Additional
Predicate:
DePuy
Attune
Knee
System
(K101433) | Reference
device:
ATTUNE™
Total
Knee
System
(K233980) | Reference
Device:
DePuy
ATTUNE™
Total Knee
System
(K201347) |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Material | AOX UHMWPE | Same | Same | Same | Same |
| Sizes | 29, 32, 35, 38,
and 41mm | Same | Same | Same | Same |
| Articular
Surface
Offset | Medial | Same | Same | Same | Same |
| Fixation
Surface | Cemented | Same | Same | Same | Same |
| Sterilization
Method | Gamma
Irradiation | Same | Same | Same | Same |
| Sterilization
Dose | First dose: 50-
60kGy
Second dose:
25-40kGy | 75- 90kGy | 75- 90kGy | 75- 90kGy | 75-
90kGy |
| Packaging | Polyurethane
bag,
polyethylene
foam,
inner/outer
PETG trays
sealed with
Tyvek lids,
carton, shrink
wrapped. | Same | Same | Same | Same |
| Shelf Life | 8 years | 5 years | 5 years | 8 years | 8 years |
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Image /page/8/Picture/1 description: The image shows the logo for DePuy Synthes, "THE ORTHOPAEDICS COMPANY of Johnson & Johnson". The logo has a red symbol on the left, followed by the company name in gray. The text below the company name is in a smaller font and is also gray, except for "Johnson & Johnson" which is in red.
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The following tests and evaluations were performed to determine impact of splitting of the sterilization dose from a single, high doses through a combination of crosslinking and terminal sterilization:
- ISO 14243-2:2016: Wear of total knee-joint prostheses – Part 2: Methods of measurement
- ASTM F1877-05: Standard Practice for Characterization of Particles
- ASTM F277-16: Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
- ASTM F648-21: Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
- . ANSI AAMI ISO 11137-1:2006/(R)2015: Sterilization of health care products – Radiation – Part 1:Requirements for development validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2019)]
- ASTM E2023-11: Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities
- . ASTM F2003-02 (Reapproved 2015): Standard Practice for Accelerated Aging of Ultra-High-Molecular-Weight Polyethylene after Gamma Irradiation in Air
- ASTM D1505-18: Standard Test Method for Density of Plastics by the Density-Gradient Technique
- ASTM F625-10 (Reapproved 2016): Standard Test Method for Measurement of Enthalpy of Fusion Percent Crystallinity and Melting Point of Ultra-High-Molecular-Weight Polyethylene by Means of Differential Scanning Calorimetry
- . ASTM F2102-17: Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
- ASTM F281-19: Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
- ASTM D638-14 Standard Test Method for Tensile Properties of Plastics
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
Based on the intended use, indications for use, and technological characteristics supported by performance testing, it can be concluded that the subject DePuy Attune™ Total Knee System are substantially equivalent to the predicate DePuy Attune™ Total Knee System (K103756).