(413 days)
No
The 510(k) summary describes a mechanical implant (revision cones) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are focused on mechanical and material properties.
No.
The device is a medical implant (revision cone) used in total knee replacement surgery to provide supplemental metaphyseal fixation, rather than directly providing therapy.
No
The device, ATTUNE Revision Cones, is an implantable orthopedic device designed to provide supplemental fixation during total knee replacement surgery. Its function is to replace or augment damaged bone structure, not to diagnose medical conditions or analyze medical data.
No
The device description clearly indicates it is a physical implant (cones) made of porous titanium, intended for surgical implantation in the tibia or femur. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in a revision total knee replacement surgery to address structural damage and bone loss in the proximal tibia or distal femur. This is a surgical intervention performed directly on the patient's body.
- Device Description: The description details the physical components (cones) designed to provide supplemental metaphyseal fixation within the bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as an implant during surgery.
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, osteoarthritis, posttraumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention.
The ATTUNE Revision cone is to be fixated into ether 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 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 Bi-Lobe, and Tibial Tri-Lobe configurations. They are compatible with select, commercially available DePuy Orthopaedics tibial base plates and stemmed femoral components.
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 Femerotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA) to demonstrate substantial equivalence of safety and efficacy with the predicate devices:
Revision Cones:
- Cone tibial fatigue testing per ASTM F1800
- Cone tibial and femoral cement pulloff test
- Biocompatibility testing
- Particulate Analysis
Magnetic Resonance Imaging safety evaluation testing was performed, and the tests evaluated the worst-case components and constructs for magnetically induced force, torque, image artefact and RF heating. The testing concluded that there are no safety issues related to magnetic field interactions under specific conditions identified in the labeling.
The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSI/AAMI ST 72:2019.
Clinical testing was not required 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.
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
§ 888.3565 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
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October 17, 2022
Depuy Ireland UC % Kathy Boggs Senior Regulatory Affairs Specialist DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582
Re: K212746
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: August 27, 2021 Received: August 30, 2021
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, 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
510(k) Number (if known) K212746
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, osteoarthritis, posttraumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention.
The ATTUNE Revision cone is to be fixated into ether 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 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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3
510(K) SUMMARY
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| Submitter Information | |
|---|---|
| Name | DePuy Ireland UC |
| Address | Loughbeg, Ringaskiddy |
| Co. Cork Munster, IRELAND | |
| Phone number | 574-404-8711 |
| Fax number | N/A |
| Establishment Registration | |
| Number | 3015516266 |
| Name of contact person | Kathy Boggs |
| Date prepared | October 14, 2022 |
| Name of device | |
| Trade or proprietary name | ATTUNE® Revision Cones |
| Common or usual 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. | |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.3565 |
| 21 CFR 888.3560 | |
| Product Code(s) | MBH |
| JWH | |
| Legally marketed device(s) to | |
| which equivalence is claimed | Primary Predicate: |
| Stryker Triathlon® Tritanium® Cone Augments (K143393) | |
| Secondary Predicate: | |
| DePuy Universal Gription™ TF Cones & Acetabular Augment System | |
| (K100391) | |
| Reference Devices: | |
| DePuy ATTUNE Revision Knee System (K160700) | |
| DePuy ATTUNE Porous FB Tibial Base, Medialized Dome Patella, and | |
| Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology | |
| (K202194) | |
| Reason for 510(k) submission | Addition of new revision cone devices to the ATTUNE Knee System. |
| 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 Bi-Lobe, and Tibial Tri-Lobe configurations. | |
| They are compatible with select, commercially available DePuy Orthopaedics | |
| tibial base plates and stemmed femoral components. | |
| Intended use of the device | Total Knee Arthroplasty |
| 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, osteoarthritis, | |
| 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 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. |
4
5
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
The DePuy ATTUNE Revision Cones are similar to the predicate Stryker Triathlon Tritanium Cone Augments (K143393) and secondary predicate DePuy Universal Gription TF (Titanium Foam) Cones & Acetabular Augment System (K100391) in principle of operation, intended use, classification, design, material, and fixation.
The ATTUNE Revision Cones are manufactured from Titanium alloy (Ti-6Al-4V), whereas the predicates are manufactured from Commercially Pure Titanium, a difference of which is negligible. The subject device is available in four differently shaped configurations and 4-5 sizes, as identified on labeling. The Stryker predicate is available in three shapes of five sizes each, and the Gription TF predicate in two shapes of four sizes each. The ATTUNE Revision Cones are intended for cementless or cemented use, as are both predicates.
The subject devices and the predicate Stryker Triathlon Tritanium Cone Augments (K143393) both utilize a 3D printed titanium porous structure for biological fixation, while the predicate DePuy Universal Gription TF Cones & Acetabular Augment System (K100391) uses Gription Titanium Foam (TF).
| Characteristics | Subject Device:
DePuy ATTUNE
Revision Cones | Primary Predicate Device:
Stryker Triathlon Tritanium
Cone Augments
K143393 | Secondary Predicate
Device:
DePuy Universal
Gription™ TF Cones &
Acetabular Augment
System
K100391 |
|-----------------|---------------------------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| FDA ProCode | MBH, JWH | MBH, JWH | JWH, KRO |
| Intended Use | Total Knee Arthroplasty | Total Knee Arthroplasty | Total Knee Arthroplasty |
| Material | Titanium Alloy
ASTM F-3001 | CP Titanium
ASTM F-1580, ASTM F-67 | CP Titanium
ASTM F-1580 |
| Fixation | Cementless or Cemented | Cementless or Cemented | Cementless or Cemented |
| Shapes | Symmetric, asymmetric,
femoral | Symmetric, asymmetric,
femoral | Symmetric, femoral |
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PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The following tests were performed (per FDA's Class II Special Controls Guidance Document: Knee Joint Patellofemerotibial and Femerotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA) to demonstrate substantial equivalence of safety and efficacy with the predicate devices:
Revision Cones:
- . Cone tibial fatigue testing per ASTM F1800
- Cone tibial and femoral cement pulloff test ●
- Biocompatibility testing ●
- Particulate Analysis
Magnetic Resonance Imaging safety evaluation testing was performed, and the tests evaluated the worst-case components and constructs for magnetically induced force, torque, image artefact and RF heating. The testing concluded that there are no safety issues related to magnetic field interactions under specific conditions identified in the labeling.
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
Clinical testing was not required to demonstrate substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The subject DePuy ATTUNE Revision Cones are substantially equivalent to the predicate devices; Stryker Triathlon Tritanium Cone Augments and DePuy Universal Gription™ TF Cones & Acetabular Augment System.