(132 days)
No
The summary describes a knee replacement implant made with 3D printing technology and porous coating for bone fixation. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are mechanical and biocompatibility tests, not related to AI/ML performance metrics.
Yes
The device is a component of a total knee replacement system, intended to replace impaired knee function due to conditions like osteoarthritis, directly addressing a medical condition for therapeutic benefit.
No
Explanation: The provided text describes the ATTUNE® Total Knee Replacement System components, which are implants used in surgery to replace parts of the knee joint. There is no mention of the device being used to diagnose conditions or diseases. Its purpose is therapeutic (replacement) rather than diagnostic.
No
The device description clearly states it is a physical implant (tibial base and patella) made of titanium alloy and UHMWPE, intended for surgical implantation in the knee joint. It is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is a total knee replacement system, consisting of implants (femoral, tibial, and patellar components) designed to replace the natural articular surface of the knee joint. These are physical implants surgically placed within the body.
- Intended Use: The intended use is for candidates for total knee replacements with severely painful and/or impaired knee function. This is a surgical intervention, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, detection of biomarkers, or any other activity associated with in vitro diagnostics.
Therefore, this device falls under the category of a medical device (specifically, a prosthetic implant), but not an IVD.
No
The FDA clearance letter explicitly states: "However, your 510(k) submission did not include a PCCP, so FDA is providing this administrative correction." This clearly indicates that the device is not authorized under a PCCP.
Intended Use / Indications for Use
The ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are intended for cementless use within the ATTUNE® Total Knee Replacement System. Porous coated implants may be used with or without cement.
Candidates for total knee replacements with a severely painful and/or impaired knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present).
Product codes
MBH, JWH
Device Description
The ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology are compatible with the ATTUNE Knee System 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 porous coating. The tibial component may be comprised of a metal tibial base with or without porous coating, and a polyethylene insert and locking components, or be an all polyethylene device. The patella component may be of an all polyethylene design or a polyethylene patella with porous metal backing.
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 were performed (per FDA's Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA) to demonstrate substantial equivalence of safety and efficacy with the predicate devices:
-Peg Fatigue Testing for ATTUNE Cementless Patella
-Stryker Peg Fatigue Benchmark Testing for ATTUNE Cementless Patella
-Biocompatibility Evaluation Report (Patella)
-MRI Testing (Tibial Base & Patella)
Clinical testing was not required to demonstrate substantial equivalence.
The subject DePuy ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are substantially equivalent to the predicate device DePuy ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology (K202194).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
FDA inadvertently indicated that the SE determination also included review and clearance of a predetermined change control plan (PCCP). However, your 510(k) submission did not include a PCCP, so FDA is providing this administrative correction.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
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.
June 28, 2024
DePuy Ireland UC % Kathy Boggs Regulatory Affairs Project Leader DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582
Re: K232303
Trade/Device Name: ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP Technology; ATTUNE® Porous Medialized Dome Patella with AFFIXIUM™ 3DP Technology; ATTUNE® Porous Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH, JWH
Dear Kathy Boggs:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on December 11, 2023. Specifically, FDA is updating this SE Letter because FDA inadvertently indicated that the SE determination also included review and clearance of a predetermined change control plan (PCCP). However, your 510(k) submission did not include a PCCP, so FDA is providing this administrative correction. Please see the attached revised clearance letter.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Lixin Liu, OHT6: Office of Orthopedic Devices, 301-796-3480, Lixin.Liu@fda.hhs.gov.
Sincerely,
Lixin Liu -S
Lixin Liu, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
June 28, 2024
DePuy Ireland UC % Kathy Boggs Project Leader Regulatory Affairs DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582
Re: K232303/S001
Trade/Device Name: ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: August 1. 2023 Received: August 1, 2023
Dear Kathy Boggs:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on December 11, 2023.
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/cdrb/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.
2
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.
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 820.70) 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).
3
Sincerely, Lixin Liu -S
Lixin Liu, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known) K232303
Device Name
ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXUM™ 3DP Technology
Indications for Use (Describe)
The ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are intended for cementless use within the ATTUNE® Total Knee Replacement System. Porous coated implants may be used with or without cement.
Candidates for total knee replacements with a severely painful and/or impaired knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present).
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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
510(K) SUMMARY
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| Contact Details | |
|---|---|
| Applicant Name | DePuy Ireland UC |
| Applicant Address | Loughbeg, Ringaskiddy |
| Co. Cork Munster, IRELAND | |
| Applicant Contact Telephone | 574-404-8711 |
| Applicant Contact | Kathy Boggs |
| Applicant Contact Email | Kboggs2@its.jnj.com |
| Correspondent Name | DePuy Orthopaedics, Inc. |
| Correspondent Address | 700 Orthopaedic Drive Warsaw IN 46582 United States |
| Correspondent Contact | |
| Telephone | 574-404-8711 |
| Correspondent Contact | Kathy Boggs |
| Correspondent Contact | |
| Kboggs2@its.jnj.com | |
| Date prepared | December 11, 2023 |
| Device Name | |
| Device Trade Name | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and |
| Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology | |
| Common Name | Total Knee Prosthesis |
| Classification Name | Knee joint patellofemorotibial metal/polymer porous-coated uncemented |
| prosthesis | |
| Knee joint patellofemorotibial polymer/metal/polymer semi-constrained | |
| cemented prosthesis | |
| Regulation Number | 21 CFR 888.3565; 21 CFR 888.3560 |
| Product Code(s) | Primary: MBH |
| Secondary: JWH | |
| Regulatory Class | Class II |
6
| Legally Marketed Predicate Devices | |
|---|---|
| K202194 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized |
| Anatomic Patella with AFFIXIUM™ 3DP Technology | |
| Legally Marketed Reference Devices | |
K132624 Stryker Triathlon Tritanium Metal-Backed Patella
Device Description Summary
The ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology are compatible with the ATTUNE Knee System 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 porous coating. The tibial component may be comprised of a metal tibial base with or without porous coating, and a polyethylene insert and locking components, or be an all polyethylene device. The patella component may be of an all polyethylene design or a polyethylene patella with porous metal backing.
Intended Use/Indications for Use
The ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are intended for cementless use within the ATTUNE® Total Knee Replacement System. Porous coated implants may be used with or without cement.
Candidates for total knee replacement include patients with and/or impaired knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present).
Indications for use Comparison
The indications for use are the same as the predicate device.
Technological Comparison
The DePuy ATTUNE Porous Fixed Bearing (FB) Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are similar to the predicate DePuy ATTUNE Porous Fixed Bearing (FB) Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Technology (K202194) in principle of operation, intended use, classification, design, materials, and fixation.
The ATTUNE Porous FB Tibial Base with AFFIXIUM 3DP Technology is manufactured from Titanium alloy (Ti-6Al-4V), available in sizes 1-10, and intended for cemented use within the ATTUNE Total Knee Replacement System. The bone apposing surfaces are comprised of 3D printed fixation features with a porous and solid geometry that enable biological fixation of the bone. The proximal surface is designed to work with currently available ATTUNE FB tibial inserts.
The ATTUNE Porous Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are manufactured from 3D printed Titanium alloy (Ti-6Al-4V) substrate for the bone opposing surfaces with the articulation surface being produced from AOX ultra high molecular weight polyethylene (UHMWPE). The patellae are available in sizes 32, 35, 38, and 41mm and are intended for cementless or cemented use within the ATTUNE Total Knee Replacement System. The articular surface is designed to work with currently available ATTUNE Femoral Components.
7
Non-Clinical and/or Clinical Tests Summary & Conclusions
The following tests were performed (per FDA's Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA) to demonstrate substantial equivalence of safety and efficacy with the predicate devices: -Peg Fatigue Testing for ATTUNE Cementless Patella
-Stryker Peg Fatigue Benchmark Testing for ATTUNE Cementless Patella
-Biocompatibility Evaluation Report (Patella)
-MRI Testing (Tibial Base & Patella)
Clinical testing was not required to demonstrate substantial equivalence.
The subject DePuy ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are substantially equivalent to the predicate device DePuy ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology (K202194).