(36 days)
Not Found
No
The document describes a mechanical implant (revision cones for knee replacement) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are mechanical tests, not algorithm validation.
No.
The device is an implantable component for total knee replacement surgery, designed to provide supplemental metaphyseal fixation; it does not directly treat or prevent a disease but rather replaces damaged anatomical structures.
No
The device, ATTUNE Revision Cones, is an orthopedic implant for total knee replacement, designed to provide supplemental metaphyseal fixation and address bone loss. It is a treatment device, not a diagnostic one.
No
The device description clearly states the device is manufactured from Titanium alloy and is a physical implant (revision cones) used in knee replacement surgery. It is a hardware device, not software.
Based on the provided information, 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 and Intended Use: The ATTUNE Revision Cones are described as implants used in revision total knee replacement surgery. They are physical components designed to be surgically implanted into the patient's bone (proximal tibia or distal femur) to provide structural support and fixation.
- Lack of Biological Sample Testing: The documentation does not mention any testing of biological samples or analysis of bodily fluids or tissues.
- Focus on Mechanical Function: The device description and performance studies focus on the mechanical properties, fixation, and compatibility of the implant with other knee replacement components.
Therefore, the ATTUNE Revision Cones are a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ATTUNE Revision Cones are intended for use with the DePuy Revision Knee Systems in a revision total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, posttraumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention.
The ATTUNE Revision cone is to be fixated into either the proximal tibia or distal femur with or without bone cement. After implantation of the mating compatible tibial or femoral component is affixed into the revision cone using bone cement.
THE POROUS TITANIUM ATTUNE REVISION CONES ARE INTENDED FOR CEMENTED OR CEMENTLESS USE.
Product codes (comma separated list FDA assigned to the subject device)
MBH, JWH
Device Description
The ATTUNE® Revision Cones provide supplemental metaphyseal fixation when necessary to make up for either the proximal tibia or distal femur bone loss. The ATTUNE Revision Cones are available in a variety of sizes of Femoral, Concentric, Tibial Tri-Lobe configurations. They are compatible with select, commercially available DePuy Orthopaedics tibial base plates and stemmed femoral components. The ATTUNE Revision Cones are manufactured from Titanium alloy (Ti-6Al-4V).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal tibia or distal femur
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:
Oxygen Content Study EOS M290 3D Printer Recycling Study
Clinical testing was not required to demonstrate substantial equivalence.
The subject DePuy ATTUNE Revision Cones are substantially equivalent to the predicate device; DePuy ATTUNE Revision Cones.
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.
Not Found
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
§ 888.3565 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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
March 10, 2023
DePuy Ireland UC Kathy Boggs Project Leader Regulatory Affairs Loughbeg, Ringaskiddy Co. Cork Munster, IRELAND
Re: K230295
Trade/Device Name: ATTUNE® Revision Cones 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: February 2, 2023 Received: February 2, 2023
Dear Kathy Boggs:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ting Song -S
Ting Song, 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
2
Indications for Use
Submission Number (if known)
Device Name
ATTUNE® Revision Cones
Indications for Use (Describe)
The ATTUNE Revision Cones are intended for use with the DePuy Revision Knee Systems in a revision total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, posttraumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention.
The ATTUNE Revision cone is to be fixated into either the proximal tibia or distal femur with or without bone cement. After implantation of the mating compatible tibial or femoral component is affixed into the revision cone using bone cement.
THE POROUS TITANIUM ATTUNE REVISION CONES ARE INTENDED FOR CEMENTED OR CEMENTLESS USE.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K230295 Page 1 of 2
| 510(k) Summary | Prepared on: 2023-02-02 | ||
|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | ||
| 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 | ||
| Device Name | 21 CFR 807.92(a)(2) | ||
| Device Trade Name | ATTUNE® Revision Cones | ||
| Common Name | Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. | ||
| Classification Name | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | ||
| Regulation Number | 888.3565; 888.3560 | ||
| Product Code | MBH; JWH | ||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| K212746 | DePuy ATTUNE® Revision Cones | MBH, JWH | |
| K14:3:993 | Stryker Triathlon® Tritanium® Cone Augments | MBH, JWH | |
| K202194 | DePuy ATTUNE® Porous FB Tibial Base, Medialized Dome Pate | MBH, JWH | |
| Device Description Summary | |||
| 21 CFR 807.92(a)(4) |
The ATTUNE® Revision Cones provide supplemental metaphyseal fixation when necessary to make up for either the proximal tibia or distal femur bone loss. The ATTUNE Revision Cones are available in a variety of sizes of Femoral, Concentric, Tibial Tri-Lobe configurations. They are compatible with select, commercially available DePuy Orthopaedics tibial base plates and stemmed femoral components. The ATTUNE Revision Cones are manufactured from Titanium alloy (Ti-6Al-4V),
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The ATTUNE Revision Cones are intended for use with the Systems in a revision total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from the materitis, posttraumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention.
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K230295 Page 2 of 2
The ATTUNE Revision cone is to be fixated into either the proximal tibia or distal femur with or without bone cement. After implantation of the cone, the mating compatible tibial or femoral component is affixed into the revision cone using bone cement.
THE POROUS TITANIUM ATTUNE REVISION CONES ARE INTENDED FOR CEMENTED OR CEMENTLESS USE.
Indications for Use Comparison
The indications for use are the same as the predicate device.
Technological Comparison
The subject DePuy ATTUNE Revision Cones are the predicate DePuy ATTUNE Revision Cones (K212746) in principle of operation, intended use, classification, design, raw material, and fixation. The only difference between that the subject device is output material grade 5 chemistry (ASTM F-2924), whereas the predicate device is output material grade 23 chemistry (ASTM F-3001).
The subject ATTUNE Revision Cones and predicate ATTUNE Revision Cones are both manufactured from Titanium alloy (Ti-6A!-4V). The subject device is available in four differently shaped configurations and 4-5 sizes, as identified on labeling. These are identical to the shape and size configurations for the predicate ATTUNE Revision Cones are intended for cementless or cemented use, as is the predicate.
The subject devices and the predicate DePuy ATTUNE Revision Cones (K212746) both utilize AFFIXIUM™ 3DP Technology printed titanium porous structure for biological fixation.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
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:
Oxygen Content Study EOS M290 3D Printer Recycling Study
Clinical testing was not required to demonstrate substantial equivalence.
The subject DePuy ATTUNE Revision Cones are substantially equivalent to the predicate device; DePuy ATTUNE Revision Cones.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)