The ATTUNE Revision LPS Insert is intended for use in prosthetic constructs for replacement of distal femur and resurfacing of the proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:

· malignant tumors (e.g., osteosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement;

· patient conditions of non-inflammatory degenerative joint disease (NIDJ), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement;

· revision cases for a failed previous prosthesis requiring extensive resection and replacement;

· severe trauma requiring extensive resection and replacement.

· post-infection bone loss, where the surgeon has elected to excise the bone and replacement is required.

Device Description

The ATTUNE Revision LPS Inserts are designed to replace the tibio-femoral articular surface of the knee joint when used in conjunction with a femoral, tibial, patellar, and other associated prostheses as required. The ATTUNE Revision LPS Insert consists of an AOX™ Antioxidant Polyethylene bearing, AOX Antioxidant Polyethylene bushings, and a forged cobalt chrome molybdenum hinge post.

AI/ML Overview

This document describes the FDA's clearance of the ATTUNE® Revision LPSTM Inserts, a medical device. It does not contain information about an AI/ML-driven device or study results related to AI performance. Therefore, I cannot extract the requested information to describe acceptance criteria and study that proves the device meets the acceptance criteria for an AI/ML-driven device.

The provided text pertains to a knee joint prosthesis and its 510(k) premarket notification to the FDA. The "acceptance criteria" and "study" discussed in this document relate to the mechanical performance, materials, and manufacturing processes of this physical medical device, demonstrating its substantial equivalence to previously cleared predicate devices.

Specifically:

Acceptance Criteria and Device Performance: These are detailed under "Non-Clinical Testing" on page 4. The device performance is deemed acceptable if it meets the requirements of the listed functional verification tests (e.g., A/P Shear Fatigue, Insert Subluxation, Hinge Post Fatigue) and ANSI AAMI ST-72:2011 for bacterial endotoxin testing. The document states that the testing "verified that the implant performance is substantially equivalent to predicate devices for anticipated in-vivo loading."
Sample size for test set and data provenance: Not applicable in the context of AI/ML. The "test set" here refers to the prototypes of the physical device or materials used for mechanical and material testing. The document doesn't specify the exact number of physical units tested but refers to standard engineering tests.
Number of experts and qualifications, adjudication method, MRMC study, standalone performance: These concepts are relevant to the evaluation of AI/ML models, not physical medical devices like a knee implant. Therefore, this information is not present.
Type of ground truth: For this physical device, the "ground truth" is defined by established engineering and biomechanical principles, industry standards (e.g., FDA Guidance, ANSI AAMI ST-72:2011), and comparison to the performance of predicate devices.
Training set sample size and ground truth establishment for training set: Not applicable to a physical device. There's no "training set" in the AI/ML sense. The "training" for such a device would involve its design, manufacturing processes, and quality control, ensuring it meets established specifications.

Summary

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October 8, 2019

Depuy (Ireland) % Soraya Hori Sr. Regulatory Affairs Associate Depuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582

Re: K191779

Trade/Device Name: Attune Revision LPS Inserts Regulation Number: 21 CFR 888.3510 Regulation Name: Knee Joint Femorotibial Metal/Polymer Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KRO Dated: July 1, 2019 Received: July 2, 2019

Dear Soraya Hori:

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 Acting 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) K191779

Device Name ATTUNE® Revision LPSTM Inserts

Indications for Use (Describe)

· malignant tumors (e.g., osteosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement;

· revision cases for a failed previous prosthesis requiring extensive resection and replacement;

· severe trauma requiring extensive resection and replacement.

· post-infection bone loss, where the surgeon has elected to excise the bone and replacement is required.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X | 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 Orthopaedics, Inc.
Address	700 Orthopaedic Drive
	Warsaw, IN 46582
Phone number	574-372-7491
Fax number	574- 371-4987
Establishment RegistrationNumber	1818910
Name of contact person	Soraya L. Hori
Date prepared	July 1, 2019
Name of device
Trade or proprietary name	ATTUNE® Revision LPSTM Inserts
Common or usual name	Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer
Classification name	Knee joint femorotibial metal/polymer constrained cemented prosthesis
Class	II
Classification panel	87 Orthopedics
Regulation	21 CFR 888.3510
Product Code(s)	KRO
Legally marketed device(s)	Primary: LPS Universal Hinge Tibial Inserts, K091453
to which equivalence isclaimed	Secondary: ATTUNE Knee System AOX Tibial Inserts, K101433,K111433, K160700
Device description	The ATTUNE Revision LPS Inserts are designed to replace the tibio-femoral articular surface of the knee joint when used in conjunction witha femoral, tibial, patellar, and other associated prostheses as required.The ATTUNE Revision LPS Insert consists of an AOX™ AntioxidantPolyethylene bearing, AOX Antioxidant Polyethylene bushings, and aforged cobalt chrome molybdenum hinge post.
Intended Use andIndications for use:	The ATTUNE Revision LPS Insert is intended for use in prostheticconstructs for replacement of distal and/or total femur and resurfacing ofthe proximal tibia, especially in cases that require extensive resectionand replacement. Specific diagnostic indications for use include:malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant celltumors, bone tumors) requiring extensive resection andreplacement;patient conditions of non-inflammatory degenerative joint disease(NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory
	joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement;
•	revision cases for a failed previous prosthesis requiring extensive resection and replacement;
•	severe trauma requiring extensive resection and replacement.
•	post-infection bone loss, where the surgeon has elected to excise the bone and replacement is required.

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Summary of Technologies / Substantial Equivalence Discussion:

The subject ATTUNE Revision LPS Insert has the same intended use, indications, manufacturing and sterilization methods as the previously cleared LPS Universal Hinge Tibial Inserts (K091453). The subject ATTUNE Revision LPS Insert has the same intended use, materials, biocompatibility, packaging configurations, and sterilization methods as the previously cleared ATTUNE Knee System AOX Tibial Inserts (K101433, K111433, K160700).

The testing provided below was used to support equivalence to the predicate devices.

Non-ClinicalTesting	Functional testing was conducted in compliance with FDA Guidance, Class II SpecialControls Guidance Document: Knee Joint Patellofemorotibial and FemorotibialMetal/Polymer Porous-Coated Uncemented Prostheses: Guidance for Industry andFDA, to verify that the implant performance is substantially equivalent to predicatedevices for anticipated in-vivo loading with the following tests:• Anterior/Posterior (A/P) Shear Fatigue Verification Test• Insert Subluxation Verification Test• Hinge Post Disassembly Test• Hinge Post Fatigue Verification Test• Hinge Post Assembly Test• Hinge Post Micromotion TestThe subject devices also meet the requirement of:• Bacterial endotoxin testing as specified in ANSI AAMI ST-72:2011.
ClinicalTesting:	Clinical testing was not necessary to determine substantial equivalence between thesubject and predicate devices.
Conclusionsdrawn fromClinical andNon-clinicaldata:	The subject ATTUNE Revision LPS Insert is substantially equivalent to the predicateLPS Universal Hinge Tibial Inserts and ATTUNE Knee System AOX Tibial Insertsregarding intended use, overall indications, design features, materials, sterilization, andmanufacturing.Clinical data and conclusions were not needed for this device.

Non-ClinicalTesting

Functional testing was conducted in compliance with FDA Guidance, Class II SpecialControls Guidance Document: Knee Joint Patellofemorotibial and FemorotibialMetal/Polymer Porous-Coated Uncemented Prostheses: Guidance for Industry andFDA, to verify that the implant performance is substantially equivalent to predicatedevices for anticipated in-vivo loading with the following tests:• Anterior/Posterior (A/P) Shear Fatigue Verification Test• Insert Subluxation Verification Test• Hinge Post Disassembly Test• Hinge Post Fatigue Verification Test• Hinge Post Assembly Test• Hinge Post Micromotion TestThe subject devices also meet the requirement of:• Bacterial endotoxin testing as specified in ANSI AAMI ST-72:2011.

ClinicalTesting:

Clinical testing was not necessary to determine substantial equivalence between thesubject and predicate devices.

Conclusionsdrawn fromClinical andNon-clinicaldata:

The subject ATTUNE Revision LPS Insert is substantially equivalent to the predicateLPS Universal Hinge Tibial Inserts and ATTUNE Knee System AOX Tibial Insertsregarding intended use, overall indications, design features, materials, sterilization, andmanufacturing.Clinical data and conclusions were not needed for this device.

Regulation Number and Section

§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.