ATTUNE™ Total Knee System Indications for Use
Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

ATTUNE™ Cementless Knee System Indications for Use
The ATTUNE™ Cementless CR and PS Femoral Components are intended for cementless use within the ATTUNE™ Total Knee Replacement System.
Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present).

LPS TM Limb Preservation System Indications for Use
The DePuy LPS System is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:

· malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement;
· patient conditions of noninflammatory 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.
The LPS System is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.
The S-ROM tibial tray and the non-porous coated straight and bowed stems are intended for cemented use only.
The porous-coated metaphyseal sleeves are intended for either cemented or cementless applications.

Sigma™ High Performance (HP) Partial Knee System Indications for Use
The SIGMA™ High Performance Partial Knee System is indicated for single compartmental knee replacement in skeletally mature individuals with osteoarthritis, post-traumatic arthritis of the tibiofemoral surfaces or a history of gout or pseudogout. All components are intended for CEMENTED USE ONLY.

Device Description

ATTUNE™ Total Knee System: A Total Knee Prosthesis is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design.

ATTUNE™ Cementless Knee System: A Total Knee Prosthesis is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant with or without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design.

LPS - Limb Preservation System: The DePuy LPSTM Limb Preservation System is designed for the replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia. The DePuy LPS system offers a variety of component options (including, but not limited to, proximal femoral bodies, segmental components, distal femoral components, femoral stems, tibial stems, proximal tibial components, hinged tibial insert bearings, metaphyseal sleeves, and adapters). The components, which can be used in conjunction with certain components from other systems, are for treatment of patients presenting bone loss and deformity associated with bone tumors resection, trauma, infection, and difficult revision arthroplasty. A total femoral replacement is possible in those cases where no part of the femur can be salvaged.

Sigma High Performance (HP) Partial Knee System: The DePuy SIGMATM High Performance Partial Knee System is a single compartmental knee prosthesis, composed of individually packaged femoral, and tibial components designed to be used in various combinations to replace the natural articular surfaces of the knee joint. The unicompartmental femoral components are Co-Cr-Mo metal implants. The metal backed tibial components are Co-Cr-Mo with polyethylene inserts. The all-polyethylene unicompartmental tibial component are manufactured from polyethylene. The unicompartmental femoral components are designed for individuals who require a higher than normal degree of flexion (up to 155°).

AI/ML Overview

This document (K233980) is a 510(k) premarket notification for several DePuy knee systems. It primarily focuses on adding updated MRI compatibility information and standardizing language in the Instructions for Use (IFU) and labels. The core claim for substantial equivalence relies on non-clinical performance data related to MRI safety and bacterial endotoxin testing, rather than a clinical study of device performance in a human-in-the-loop or standalone AI context.

Therefore, the requested information regarding acceptance criteria, study design for device performance, sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided from this document as it pertains to a different type of device (knee implants) and regulatory submission (510(k) for labeling changes related to MRI safety, not an AI/software as a medical device performance study).

However, I can extract the acceptance criteria for the non-clinical performance tests that were conducted, and the reported performance as implied by the conclusion of substantial equivalence.

Here's what can be extracted and what cannot:

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

For MRI safety, the acceptance criteria are implicit in meeting the standards listed. The reported "performance" is that the devices meet these standards, thus proving MRI safety.

Acceptance Criteria (Implicit)	Reported Device Performance (Implied)
Conformance to ASTM F2503-23 (Standard practice for marking medical devices for safety in MR environment)	Met
Conformance to ASTM F2182-19E2 (Measurement of Radio Frequency Induced Heating On or Near Passive Implants during MR)	Met
Conformance to ASTM F2052-21 (Measurement of Magnetically Induced Displacement Force on Medical Devices in the MR Environment)	Met
Conformance to ASTM F2213-17 (Measurement of Magnetically Induced Torque on Medical Devices in the MR Environment)	Met
Conformance to ASTM F2119-07 (Evaluation of MR Image Artifacts from Passive Implants)	Met
Conformance to ANSI/AAMI ST 72:2019 (Bacterial Endotoxin Testing)	Met

2. Sample sizes used for the test set and the data provenance

Sample Size: Not applicable in the context of clinical or AI performance. The "test set" here would refer to the physical devices tested for MRI compatibility and bacterial endotoxin. The document does not specify the number of individual devices subjected to these non-clinical tests.
Data Provenance: Not applicable for a typical AI/software study. The "data" here are the results from physical and chemical testing of the devices.

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

This is not applicable as there is no "ground truth" established by experts in the context of an AI or diagnostic device study. The ground truth for these tests is defined by the physical properties measured according to established ASTM and ANSI standards.

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

This is not applicable as this is not an image-based or diagnostic AI study requiring human adjudication.

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

No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical tests were conducted to demonstrate substantial equivalence." (pages 6, 9, 12, 15)

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

This is not applicable as the device is a knee implant, not an algorithm or software. The "performance" assessment is of the physical and material properties of the implant itself in relation to MRI safety.

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

The "ground truth" for the non-clinical tests is established by the physical and chemical properties measured according to the specified ASTM and ANSI international standards for MRI compatibility and bacterial endotoxin levels.

8. The sample size for the training set

Not applicable. There is no AI model or training set involved in this regulatory submission.

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

Not applicable. There is no AI model or training set involved in this regulatory submission.

In summary: This FDA 510(k) submission for DePuy knee systems is related to changes in labeling for MRI compatibility, not an AI/software/diagnostic device. The "study" described focuses on non-clinical bench testing to demonstrate MRI safety and bacterial endotoxin compliance, adhering to recognized industry standards, rather than clinical performance or AI algorithm validation.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 21, 2024

DePuy Ireland UC % Meagan Robles Regulatory Affairs Project Leader DePuy Synthes Loughbeg Ringaskiddy, Co. Cork Munster Ireland

Re: K233980

Trade/Device Name: ATTUNE Total Knee System. ATTUNE Cementless Knee System. LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System Regulation Number: 21 CFR 888.3510 Regulation Name: Knee Joint Femorotibial Metal/Polymer Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KRO, OIY, MBH, JWH, NPJ, HRY, KRR Dated: December 15, 2023 Received: December 18, 2023

Dear Meagan Robles:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Ouality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Lixin Liu -S

Lixin Liu, 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)

K233980

Device Name

ATTUNE™ Total Knee System;

ATTUNE™ Cementless Knee System :

LPS™ Limb Preservation System;

Sigma™ High Performance (HP) Partial Knee System

Indications for Use (Describe)

ATTUNE™ Total Knee System Indications for Use

Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

ATTUNE™ Cementless Knee System Indications for Use

The ATTUNE™ Cementless CR and PS Femoral Components are intended for cementless use within the ATTUNE™ Total Knee Replacement System.

Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present).

LPS TM Limb Preservation System Indications for Use

The DePuy LPS System is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:

· malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement;
· patient conditions of noninflammatory 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.

The LPS System is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.

The S-ROM tibial tray and the non-porous coated straight and bowed stems are intended for cemented use only.

The porous-coated metaphyseal sleeves are intended for either cemented or cementless applications.

Sigma™ High Performance (HP) Partial Knee System Indications for Use

The SIGMA™ High Performance Partial Knee System is indicated for single compartmental knee replacement in skeletally mature individuals with osteoarthritis, post-traumatic arthritis of the tibiofemoral surfaces or a history of gout or pseudogout. All components are intended for CEMENTED USE ONLY.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/4/Picture/0 description: The image shows the logo for DePuy Synthes, a company that specializes in orthopedics. The logo features a red graphic element on the left, followed by the company name in gray, with the words "THE ORTHOPAEDICS COMPANY of Johnson & Johnson" in smaller font below. The logo is simple and modern, and the use of red and gray gives it a professional look.

510(K) SUMMARY

(As required by 21 CFR 807.92 and 21 CFR 807.93)

Contact Details
Applicant Name	DePuy Ireland UC
Applicant Address	Loughbeg, RingaskiddyCo. Cork Munster, IRELAND
Applicant Contact Telephone	574-400-6438
Applicant Contact	Meagan Robles
Applicant Contact Email	Mroble10@its.jnj.com
Correspondent Name	DePuy Orthopaedics, Inc.
Correspondent Address	700 Orthopaedic Drive Warsaw IN 46582 United States
Correspondent ContactTelephone	574-400-6438
Correspondent Contact	Meagan Robles
Correspondent ContactEmail	Mroble10@its.jnj.com
Date prepared	December 21, 2023
Name of device
Trade or proprietary name	Attune ™ Total Knee System
Common or usual name	Total Knee Replacement Prosthesis
Classification name	21 CFR 888.3560 – Knee joint patellofemorotibial polymer/metal/polymersemi-constrained cemented prosthesis
Class	II
Classification panel	87 Orthopedics
Regulation	Class II - 21 CFR 888.3560
Product Code(s)	JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented,Polymer/Metal/Polymer
	OIY: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented,Polymer + Additive/Metal/Polymer + Additive
Legally marketed device(s) towhich equivalence is claimed	Primary Predicate: K111433 - DePuy Attune ™ Knee SystemSecondary Predicate: K170806 – ATTUNE Cemented Tibial Base, FixedBearingReference Devices:
K232303 - ATTUNE Porous Fixed Bearing Tibial Base, Medialized DomePatella and Medialized Anatomic Patella with AFFIXIUMTM 3DPTechnologyK212746 & K230295 - ATTUNE Revision Cones
Reason for 510(k) submission	In accordance with Section 510(k) of the Medical Device Amendments of1976 and Subpart E of Part 807, Title 21 of the Code of Federal Regulations,and as per the FDA Guidance, Bundling Multiple Devices or MultipleIndications in a Single Submission: Guidance for Industry and FDA Staff(June 2007), DePuy Ireland UC has compiled a Bundled Traditional 510(k)Premarket Notification to modify labeling to include updated MRIcompatibility information for DePuy ATTUNE™ Total Knee System(K111433, K170806). Updates include modernizing and standardizing thelanguage of the Instructions for Use (IFU) and labels.
Device description	A Total Knee Prosthesis is composed of individually packaged femoral, tibialand patellar components designed to replace the natural articular surface of theknee joint. The femoral component is a metal implant without a porouscoating. The tibial component may be an all polyethylene component orcomprised of a metal tibial base without porous coating, and a polyethyleneinsert and locking components. The patella component may be of an allpolyethylene design.
Intended use of the device	Total knee arthroplasty is intended to provide increased patient mobility andreduced pain by replacing the damaged knee joint articulation in patientswhere there is evidence of sufficient sound bone to seat and support thecomponents. Total knee replacement may be considered for younger patientsif, in the opinion of the surgeon, an unequivocal indication for total kneereplacement outweighs the risks associated with the age of the patient, and iflimited demands regarding activity and knee joint loading can be assured.This includes severely disabled patients with multiple joint involvement forwhom a gain in knee mobility may lead to an expectation of significantimprovement in the quality of their lives.
Indications for use	Candidates for total knee replacement include patients with a severelypainful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.
Substantial Equivalence	There are no changes in design, manufacturing, principle of operation,indication, or intended use. The only change is the addition of MagneticResonance (MR) safety information in the Instructions for Use (IFU) and theupdate of language in the IFU as discussed in Performance Testing -Bench.

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Image /page/5/Picture/0 description: The image shows the logo for DePuy Synthes, a company that specializes in orthopedics. The logo features a red symbol resembling a stylized spine or interconnected network, followed by the company name in gray, sans-serif font. Below the company name, in smaller font, is the tagline "THE ORTHOPAEDICS COMPANY of Johnson & Johnson", with "Johnson & Johnson" written in a distinctive script font.

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Image /page/6/Picture/1 description: The image shows the logo for DePuy Synthes, a company that specializes in orthopedics and is part of Johnson & Johnson. The logo features a red symbol resembling a stylized bone or joint, followed by the company name in gray, with the tagline "THE ORTHOPAEDICS COMPANY of Johnson & Johnson" underneath. The Johnson & Johnson part of the tagline is in red.

SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

PERFORMANCE DATA

SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The following tests were performed (per FDA's Testing and Labeling Medical Devices for Safety in the Magnetic

Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff, October 2023) to determine Magnetic Resonance (MR) Safety:

ASTM F2503-23 - Standard practice for marking medical devices and other items for safety in the magnetic resonance environment

ASTM F2182 -19E2 - Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants during Magnetic Resonance

ASTM F2052-21 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment

ASTM F2213-17 - Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment

ASTM F2119-07 - Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants

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

No clinical tests were conducted to demonstrate substantial equivalence.

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The subject DePuy ATTUNE Total Knee System are substantially equivalent to the predicate ATTUNE Total Knee System (K111433, K170806).

Contact Details
Applicant Name	DePuy Ireland UC
Applicant Address	Loughbeg, RingaskiddyCo. Cork Munster, IRELAND
Applicant Contact Telephone	574-400-6438
Applicant Contact	Meagan Robles

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Image /page/7/Picture/1 description: The image shows the logo for DePuy Synthes, which is the orthopedics company of Johnson & Johnson. The logo features a red symbol on the left, followed by the company name in gray. Below the company name, there is a smaller text indicating that it is the orthopedics company of Johnson & Johnson, with the Johnson & Johnson part in red.

Applicant Contact Email	Mroble10@its.jnj.com
Correspondent Name	DePuy Orthopaedics, Inc.
Correspondent Address	700 Orthopaedic Drive Warsaw IN 46582 United States
Correspondent ContactTelephone	574-400-6438
Correspondent Contact	Meagan Robles
Correspondent ContactEmail	Mroble10@its.jnj.com
Date prepared	December 21, 2023
Name of device
Trade or proprietary name	ATTUNE ™ Cementless Knee System
Common or usual name	Total Knee Prosthesis
Classification name	21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis
Class	II
Classification panel	87 Orthopedics
Regulation	Class II - 21 CFR 888.3565
Product Code(s)	MBH: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained,Uncemented, Porous, Coated, Polymer/Metal/PolymerJWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented,Polymer/Metal/Polymer
Legally marketed device(s) towhich equivalence is claimed	Primary Predicate: K140881 - ATTUNE ™ Knee System- Cementless CRand PS Femoral ComponentsReference Devices:K232303 – ATTUNE Porous Fixed Bearing Tibial Base, Medialized DomePatella and Medialized Anatomic Patella with AFFIXIUM™ 3DPTechnologyK212746 & K230295 - ATTUNE Revision Cones
Reason for 510(k) submission	In accordance with Section 510(k) of the Medical Device Amendments of1976 and Subpart E of Part 807, Title 21 of the Code of Federal Regulations,and as per the FDA Guidance, Bundling Multiple Devices or MultipleIndications in a Single Submission: Guidance for Industry and FDA Staff(June 2007), DePuy Ireland UC has compiled a Bundled Traditional 510(k)Premarket Notification to modify labeling to include updated MRIcompatibility information for DePuy, ATTUNE™ Cementless Knee System(K140881). Updates include modernizing and standardizing the language ofthe Instructions for Use (IFU) and labels.
Device description	A Total Knee Prosthesis is composed of individually packaged femoral, tibialand patellar components designed to replace the natural articular surface of theknee joint. The femoral component is a metal implant with or without a porouscoating. The tibial component may be an all polyethylene component orcomprised of a metal tibial base without porous coating, and a polyethyleneinsert and locking components. The patella component may be of an allpolyethylene design.
Intended use of the device	Total knee arthroplasty is intended to provide increased patient mobility andreduced pain by replacing the damaged knee joint articulation in patients wherethere is evidence of sufficient sound bone to seat and support the components.Total knee replacement may be considered for younger patients if, in theopinion of the surgeon, an unequivocal indication for total knee replacementoutweighs the risks associated with the age of the patient, and if limiteddemands regarding activity and knee joint loading can be assured. This includesseverely crippled disabled patients with multiple joint involvement for whom again in knee mobility may lead to an expectation of significant improvement inthe quality of their lives.
Indications for use	The ATTUNE™ Cementless CR and PS Femoral Components are intendedfor cementless use within the ATTUNE™ Total Knee Replacement System.Candidates for total knee replacement include patients with a severelypainful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate boneis present).
Substantial Equivalence	There are no changes in design, manufacturing, principle of operation,indication, or intended use.The only change is the addition of Magnetic Resonance (MR) safetyinformation in the Instructions for Use (IFU) and the update of language in theIFU as discussed in Performance Testing - Bench.

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Image /page/8/Picture/1 description: The image displays the logo for "DePuy Synthes, the orthopedics company of Johnson & Johnson". The logo features a red abstract symbol resembling a stylized spine or interconnected loops on the left. To the right of the symbol, the words "DePuy Synthes" are written in a gray, sans-serif font. Below "DePuy Synthes", the text "THE ORTHOPAEDICS COMPANY of Johnson & Johnson" is written in a smaller font size.

SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

PERFORMANCE DATA

SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The following tests were performed (per FDA's Testing and Labeling Medical Devices for Safety in the Magnetic

Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff, October 2023) to determine Magnetic Resonance (MR) Safety:

ASTM F2503-23 - Standard practice for marking medical devices and other items for safety in the magnetic resonance environment

{9}------------------------------------------------

Image /page/9/Picture/1 description: The image shows the logo for DePuy Synthes, The Orthopaedics Company of Johnson & Johnson. The logo features a red abstract symbol on the left, followed by the company name in gray, with "DePuy" slightly larger than "Synthes". Below the company name, in smaller gray font, is the text "THE ORTHOPAEDICS COMPANY of", and then "Johnson & Johnson" in red script.

ASTM F2182 -19E2 - Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants during Magnetic Resonance

ASTM F2052-21 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment

ASTM F2213-17 - Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment

ASTM F2119-07 - Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants

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

No clinical tests were conducted to demonstrate substantial equivalence.

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The subject DePuy ATTUNE Cementless Knee System are substantially equivalent to the predicate ATTUNE Knee System - Cementless (K140881).

Contact Details
Applicant Name	DePuy Ireland UC
Applicant Address	Loughbeg, RingaskiddyCo. Cork Munster, IRELAND
Applicant Contact Telephone	574-400-6438
Applicant Contact	Meagan Robles
Applicant Contact Email	Mroble10@its.jnj.com

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Image /page/10/Picture/1 description: The image shows the logo for DePuy Synthes, a company that specializes in orthopedics. The logo features a red symbol on the left, followed by the company name in gray. Below the company name, it says "THE ORTHOPAEDICS COMPANY of Johnson & Johnson" in a smaller font.

Correspondent Name	DePuy Orthopaedics, Inc.
Correspondent Address	700 Orthopaedic Drive Warsaw IN 46582 United States
Correspondent ContactTelephone	574-400-6438
Correspondent Contact	Meagan Robles
Correspondent ContactEmail	Mroble10@its.jnj.com
Date prepared	December 21, 2023
Name of device
Trade or proprietary name	LPS - Limb Preservation System
Common or usual name	Total Femur Replacement Prosthesis
	Proximal Tibial Replacement Prosthesis
Classification name	21 CFR 888.3510 - Knee Joint Femorotibial Metal/Polymer Constrained Cemented Prosthesis21 CFR 888.3560 - Knee joint patellofemorotibial polymer/metal/polymer semi-constrainedcemented prosthesis21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncementedprosthesis
Class	II
Classification panel	87 Orthopedics
Regulation	Class II - 21 CFR 888.3510; 21 CFR 888.3560; 21 CFR 888.3365
Product Code(s)	JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented,Polymer/Metal/Polymer
	MBH: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained,Uncemented, Porous, Coated, Polymer/Metal/Polymer
	KRO: Prosthesis, Knee, Femorotibial, Constrained, Cemented,Metal/Polymer
Legally marketed device(s) towhich equivalence is claimed	Primary Predicate: K091453 - DePuy LPS Universal Hinge Insert AssemblySecondary Predicates: K033959 – LPS ; K003182 – Orthogenesis LPSSystemReference Devices:K232303 - ATTUNE Porous Fixed Bearing Tibial Base, Medialized DomePatella and Medialized Anatomic Patella with AFFIXIUMTM 3DPTechnologyK212746 & K230295 - ATTUNE Revision Cones
Reason for 510(k) submission	In accordance with Section 510(k) of the Medical Device Amendments of1976 and Subpart E of Part 807, Title 21 of the Code of Federal Regulations,and as per the FDA Guidance, Bundling Multiple Devices or Multiple
	Indications in a Single Submission: Guidance for Industry and FDA Staff(June 2007), DePuy Ireland UC has compiled a Bundled Traditional 510(k)Premarket Notification to modify labeling to modernize and standardize thelanguage of the Instructions for Use (IFU) and labels with continued use of"Safety in MRI not evaluated" unknownfor DePuy LPSTM - Limb PreservationSystem (K091453, K033959, K003182).
Device description	The DePuy LPSTM Limb Preservation System is designed for thereplacement of the mid-shaft portion of the femur, proximal, distal and/ortotal femur, and proximal tibia. The DePuy LPS system offers a variety ofcomponent options (including, but not limited to, proximal femoral bodies,segmental components, distal femoral components, femoral stems, tibialstems, proximal tibial components, hinged tibial insert bearings, metaphysealsleeves, and adapters). The components, which can be used in conjunctionwith certain components from other systems, are for treatment of patientspresenting bone loss and deformity associated with bone tumors resection,trauma, infection, and difficult revision arthroplasty. A total femoralreplacement is possible in those cases where no part of the femur can besalvaged.
Intended use of the device	The DePuy LPS System is intended for use in replacement of the mid-shaftportion of the femur, proximal, distal and/or total femur, and proximal tibia,especially in cases that require extensive resection and replacement.
Indications for use	The DePuy LPS System is intended for use in replacement of the mid-shaftportion of the femur, proximal, distal and/or total femur, and proximal tibia,especially in cases that require extensive resection and replacement.Specific diagnostic indications for use include:malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant celltumors, bone tumors) requiring extensive resection and replacement; patient conditions of noninflammatory degenerative joint disease(NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory jointdisease (IJD), e.g., rheumatoid arthritis, requiring extensive resection andreplacement; revision cases for a failed previous prosthesis requiring extensiveresection and replacement; severe trauma requiring extensive resection and replacement. The LPS System is also intended for use in bone loss post-infection, wherethe surgeon has elected to excise the bone and replacement is required.
	The S-ROM tibial tray and the non-porous coated straight and bowed stemsare intended for cemented use only.
	The porous-coated metaphyseal sleeves are intended for either cemented orcementless applications.
Substantial Equivalence	There are no changes in design, manufacturing, principle of operation,indication, or intended use.
	The only change is the addition of Magnetic Resonance (MR) safetyinformation in the Instructions for Use (IFU) and the update of language in theIFU as discussed in Performance Testing - Bench.
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO

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Image /page/11/Picture/0 description: The image is a logo for DePuy Synthes, a company that specializes in orthopedics. The logo features a red graphic to the left of the company name, which is written in gray. Below the company name, in smaller red font, is the text "THE ORTHOPAEDICS COMPANY of Johnson & Johnson."

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Image /page/12/Picture/0 description: The image shows the logo for DePuy Synthes, a company that specializes in orthopedics and is part of Johnson & Johnson. The logo features a red abstract symbol on the left, followed by the company name "DePuy Synthes" in gray, bold letters. Below the company name, there is a tagline that reads "THE ORTHOPAEDICS COMPANY of Johnson & Johnson" in smaller letters.

THE PREDICATE DEVICE