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.

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.

AI/ML Overview

This document describes a 510(k) premarket notification for the ATTUNE® Revision Cones. It does not involve a device that relies on algorithms, AI, or machine learning, but rather a medical implant. Therefore, the requested information regarding acceptance criteria, study details for AI/algorithm performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance simply isn't applicable to this submission.

The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and non-clinical performance testing for a medical implant, not an AI-driven diagnostic or therapeutic device.

However, I can extract information related to the device's performance and the non-clinical tests conducted to support its substantial equivalence, even if it doesn't align with the typical AI/ML criteria you've provided.

Here's a summary of the non-clinical tests performed, which serve as the "study" proving the device meets its mechanical and material acceptance criteria:

Non-Clinical Performance Data:

Acceptance Criteria / Test	Reported Device Performance	Comments
Cone tibial fatigue testing per ASTM F1800	Performed	Demonstrates durability and resistance to cyclical loading.
Cone tibial and femoral cement pulloff test	Performed	Evaluates the strength of the fixation method with bone cement.
Biocompatibility testing	Performed	Confirms the material's safety for use within the human body.
Particulate Analysis	Performed	Likely assesses wear particles generated from the device, important for long-term implant success.
Magnetic Resonance Imaging (MRI) safety evaluation testing	Performed, concluded no safety issues under specific conditions identified in labeling.	Assesses MRI compatibility, including magnetically induced force, torque, image artifact, and RF heating.
Bacterial Endotoxin Testing per ANSI/AAMI ST 72:2019	Meets the requirement	Ensures the device is free from harmful levels of bacterial endotoxins.

Regarding the specific questions about AI/ML studies:

A table of acceptance criteria and the reported device performance: See table above, adapted for non-AI device.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. These were non-clinical, mechanical/material tests. "Sample size" would refer to the number of devices tested, which is not specified in this summary. Data provenance is not relevant.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for mechanical tests is typically established by engineering specifications and objective measurements, not expert consensus.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Material and mechanical tests have clear pass/fail criteria, not subjective adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical implant, not a diagnostic AI.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device does not involve an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable to an AI context. For the non-clinical tests, the "ground truth" is adherence to industry standards (e.g., ASTM F1800, ANSI/AAMI ST 72:2019) and engineering specifications.
The sample size for the training set: Not applicable. There is no training set for a mechanical implant.
How the ground truth for the training set was established: Not applicable. There is no training set.

In conclusion, this document pertains to the regulatory clearance of a physical medical device (knee revision cones) and not an AI/ML-driven product. Therefore, the specific criteria for AI/ML studies are not met, as they are not relevant to this type of device submission. The "studies" conducted were non-clinical tests demonstrating the physical and material safety and performance of the implant.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K212746

Device Name ATTUNE® Revision Cones

Indications for Use (Describe)

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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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 RegistrationNumber	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 uncementedprosthesis.Knee joint patellofemorotibial polymer/metal/polymer semi-constrainedcemented prosthesis.
Class	II
Classification panel	87 Orthopedics
Regulation	21 CFR 888.356521 CFR 888.3560
Product Code(s)	MBHJWH
Legally marketed device(s) towhich 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, andMedialized 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 fixationwhen necessary to make up for either the proximal tibia or distal femur boneloss. The ATTUNE Revision Cones are available in a variety of sizes ofFemoral, Concentric, Tibial Bi-Lobe, and Tibial Tri-Lobe configurations.They are compatible with select, commercially available DePuy Orthopaedicstibial 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 DePuyRevision Knee Systems in a revision total knee replacement surgery forpatients suffering from severe pain and disability due to permanentstructural damage resulting from rheumatoid arthritis, osteoarthritis,posttraumatic arthritis, collagen disorders, pseudogout, trauma or failedprior surgical intervention.The ATTUNE Revision cone is to be fixated into either the proximal tibiaor distal femur with or without bone cement. After implantation of the cone,the mating compatible tibial or femoral component is affixed into therevision cone using bone cement.THE POROUS TITANIUM ATTUNE REVISION CONES AREINTENDED FOR CEMENTED OR CEMENTLESS USE.

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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 ATTUNERevision Cones	Primary Predicate Device:Stryker Triathlon TritaniumCone AugmentsK143393	Secondary PredicateDevice:DePuy UniversalGription™ TF Cones &Acetabular AugmentSystemK100391
FDA ProCode	MBH, JWH	MBH, JWH	JWH, KRO
Intended Use	Total Knee Arthroplasty	Total Knee Arthroplasty	Total Knee Arthroplasty
Material	Titanium AlloyASTM F-3001	CP TitaniumASTM F-1580, ASTM F-67	CP TitaniumASTM 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.

Regulation Number and Section

§ 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.