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.

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).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the ATTUNE® Revision Cones, specifically addressing the requested information:

Analysis of the Provided Text:

The document is a 510(k) summary for the ATTUNE® Revision Cones. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device with performance-based acceptance criteria against a specific medical outcome. The submission explicitly states that "Clinical testing was not required to demonstrate substantial equivalence."

Therefore, many of the requested points related to clinical performance, ground truth, and human reader studies are not applicable to this 510(k) submission. The "acceptance criteria" here implicitly refer to meeting the requirements for substantial equivalence by demonstrating similar safety and efficacy through non-clinical testing and comparison to an established predicate.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance
Similar Indications for Use	The indications for use are stated as "the same as the predicate device" (ATTUNE® Revision Cones K212746).
Similar Technological Characteristics	The subject device shares "principle of operation, intended use, classification, design, raw material, and fixation" with the predicate (ATTUNE® Revision Cones K212746).
Acceptable Performance in Non-Clinical Testing	Two specific non-clinical tests were performed: * Oxygen Content Study * EOS M290 3D Printer Recycling Study The document concludes that these tests, performed per relevant FDA guidance, "demonstrate substantial equivalence of safety and efficacy with the predicate devices." No specific quantitative performance metrics from these tests are provided in the summary, only the fact that they were conducted and supported substantial equivalence.
Material Equivalence (with noted difference)	The subject device uses Titanium alloy (Ti-6Al-4V) with Grade 5 chemistry (ASTM F-2924), while the predicate uses Grade 23 chemistry (ASTM F-3001) of the same alloy. This difference is acknowledged, and presumably, the non-clinical tests address the potential implications of this change to maintain equivalence.
Manufacturing Process Equivalence	Both the subject and predicate devices utilize "AFFIXIUM™ 3DP Technology printed titanium porous structure for biological fixation," indicating a consistent manufacturing approach for the porous structure.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This is a 510(k) submission based on non-clinical testing for substantial equivalence, not a clinical study involving a "test set" of patients or data in the traditional sense.
The "samples" would refer to the physical devices or materials tested in the Oxygen Content Study and EOS M290 3D Printer Recycling Study. The specific number of samples tested for these non-clinical studies is not provided in this summary.
Data provenance for these engineering tests would typically be from the manufacturer's labs (DePuy Ireland UC). Since clinical data was not required, there is no patient data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As this is a non-clinical submission for substantial equivalence, there was no "ground truth" to be established by experts in the context of clinical diagnosis or outcome. The "truth" here is compliance with engineering standards and demonstration of equivalence through lab testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. As there is no clinical "test set" requiring interpretation or adjudication, this concept does not apply.

5. 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 device is a revision cone for knee replacement surgery, not an AI or imaging diagnostic device. No MRMC study was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical implant, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence rests on:
- Regulatory definitions: Demonstrating that the device meets the criteria set forth in relevant FDA regulations and guidance documents (e.g., 21 CFR 888.3565, and the "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses").
- Engineering standards: The non-clinical tests (Oxygen Content Study, EOS M290 3D Printer Recycling Study) would have a "ground truth" based on established material science and engineering principles, and potentially specified ASTM or ISO standards for material properties and manufacturing processes.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

Summary

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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.

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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 -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

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Indications for Use

Submission Number (if known)

K230295

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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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 Summary21 CFR 807.92(a)(4)

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)

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.