ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System

K233980 · Depuy Ireland UC · KRO · Mar 21, 2024 · Orthopedic

Device Facts

• Record ID: K233980
• Device Name: ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System
• Applicant: Depuy Ireland UC
• Product Code: KRO · Orthopedic
• Decision Date: Mar 21, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3510
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Total knee arthroplasty is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely disabled patients with multiple joint involvement for whom a gain in knee mobility may lead to an expectation of significant improvement in the quality of their lives.

Device Story

The ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, and Sigma HP Partial Knee System are orthopedic prostheses designed to replace damaged knee joint articular surfaces. Components include femoral, tibial, and patellar implants made of metal (e.g., Co-Cr-Mo) and/or polyethylene. The devices are used by orthopedic surgeons in clinical settings to restore mobility and reduce pain in patients with severe joint degeneration, trauma, or tumors. This submission updates labeling to include standardized Magnetic Resonance (MR) safety information. The devices are passive implants; they do not utilize software or algorithms. Clinical decision-making is based on surgeon assessment of bone quality and patient condition. Benefits include improved joint function and quality of life.

Clinical Evidence

No clinical tests were conducted to demonstrate substantial equivalence. Bench testing only.

Technological Characteristics

Prosthetic knee components constructed from metal (Co-Cr-Mo) and polyethylene. Passive implants. MR safety testing performed per ASTM F2503-23, F2182-19E2, F2052-21, F2213-17, and F2119-07. Bacterial endotoxin testing per ANSI/AAMI ST 72:2019. No software or electronic components.

Indications for Use

Indicated for patients with severely painful and/or disabled joints resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implants. LPS system also indicated for malignant tumors, noninflammatory/inflammatory degenerative joint disease, revision cases, severe trauma, and bone loss post-infection requiring extensive resection. Sigma HP Partial Knee System indicated for single compartmental replacement in skeletally mature individuals with osteoarthritis, post-traumatic arthritis of tibiofemoral surfaces, or history of gout or pseudogout.

Regulatory Classification

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).

Predicate Devices

• DePuy Attune Knee System (K111433)
• ATTUNE Cemented Tibial Base, Fixed Bearing (K170806)
• ATTUNE Knee System- Cementless CR and PS Femoral Components (K140881)
• DePuy LPS Universal Hinge Insert Assembly (K091453)
• LPS (K033959)
• Orthogenesis LPS System (K003182)
• Sigma High Performing Unity Knee Resurfacing (K070267)
• DePuy GCK Femoral and Tibial Components (K070849)
• DePuy Graduated Compartmental Knee (GCK) (K061648)

Reference Devices

• ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology (K232303)
• ATTUNE Revision Cones (K212746)
• ATTUNE Revision Cones (K230295)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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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, Ringaskiddy<br>Co. Cork Munster, IRELAND |
| Applicant Contact Telephone | 574-400-6438 |
| Applicant Contact | Meagan Robles |
| Applicant Contact Email | [e-mail] |
| Correspondent Name | DePuy Orthopaedics, Inc. |
| Correspondent Address | 700 Orthopaedic Drive Warsaw IN 46582 United States |
| Correspondent Contact<br>Telephone | 574-400-6438 |
| Correspondent Contact | Meagan Robles |
| Correspondent Contact<br>Email | [e-mail] |
| 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/polymer<br>semi-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,<br>Polymer/Metal/Polymer |
| | OIY: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented,<br>Polymer + Additive/Metal/Polymer + Additive |
| Legally marketed device(s) to<br>which equivalence is claimed | Primary Predicate: K111433 - DePuy Attune ™ Knee System<br>Secondary Predicate: K170806 – ATTUNE Cemented Tibial Base, Fixed<br>Bearing<br>Reference Devices: |
| K232303 - ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome<br>Patella and Medialized Anatomic Patella with AFFIXIUMTM 3DP<br>Technology<br>K212746 & K230295 - ATTUNE Revision Cones | |
| Reason for 510(k) submission | In accordance with Section 510(k) of the Medical Device Amendments of<br>1976 and Subpart E of Part 807, Title 21 of the Code of Federal Regulations,<br>and as per the FDA Guidance, Bundling Multiple Devices or Multiple<br>Indications in a Single Submission: Guidance for Industry and FDA Staff<br>(June 2007), DePuy Ireland UC has compiled a Bundled Traditional 510(k)<br>Premarket Notification to modify labeling to include updated MRI<br>compatibility information for DePuy ATTUNE™ Total Knee System<br>(K111433, K170806). Updates include modernizing and standardizing the<br>language of the Instructions for Use (IFU) and labels. |
| Device description | A Total Knee Prosthesis is composed of individually packaged femoral, tibial<br>and patellar components designed to replace the natural articular surface of the<br>knee joint. The femoral component is a metal implant without a porous<br>coating. The tibial component may be an all polyethylene component or<br>comprised of a metal tibial base without porous coating, and a polyethylene<br>insert and locking components. The patella component may be of an all<br>polyethylene design. |
| Intended use of the device | Total knee arthroplasty is intended to provide increased patient mobility and<br>reduced pain by replacing the damaged knee joint articulation in patients<br>where there is evidence of sufficient sound bone to seat and support the<br>components. Total knee replacement may be considered for younger patients<br>if, in the opinion of the surgeon, an unequivocal indication for total knee<br>replacement outweighs the risks associated with the age of the patient, and if<br>limited demands regarding activity and knee joint loading can be assured.<br>This includes severely disabled patients with multiple joint involvement for<br>whom a gain in knee mobility may lead to an expectation of significant<br>improvement in the quality of their lives. |
| Indications for use | Candidates for total knee replacement include patients with a severely<br>painful and/or severely disabled joint resulting from osteoarthritis, post-<br>traumatic arthritis, rheumatoid arthritis, or a failed previous implant. |
| Substantial Equivalence | There are no changes in design, manufacturing, principle of operation,<br>indication, or intended use. The only change is the addition of Magnetic<br>Resonance (MR) safety information in the Instructions for Use (IFU) and the<br>update of language in the IFU as discussed in Performance Testing -<br>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, Ringaskiddy<br>Co. 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 | [e-mail] |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Correspondent Name | DePuy Orthopaedics, Inc. |
| Correspondent Address | 700 Orthopaedic Drive Warsaw IN 46582 United States |
| Correspondent Contact<br>Telephone | 574-400-6438 |
| Correspondent Contact | Meagan Robles |
| Correspondent Contact<br>Email | [e-mail] |
| 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-<br>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,<br>Uncemented, Porous, Coated, Polymer/Metal/Polymer<br>JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented,<br>Polymer/Metal/Polymer |
| Legally marketed device(s) to<br>which equivalence is claimed | Primary Predicate: K140881 - ATTUNE ™ Knee System- Cementless CR<br>and PS Femoral Components<br>Reference Devices:<br>K232303 – ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome<br>Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP<br>Technology<br>K212746 & K230295 - ATTUNE Revision Cones |
| Reason for 510(k) submission | In accordance with Section 510(k) of the Medical Device Amendments of<br>1976 and Subpart E of Part 807, Title 21 of the Code of Federal Regulations,<br>and as per the FDA Guidance, Bundling Multiple Devices or Multiple<br>Indications in a Single Submission: Guidance for Industry and FDA Staff<br>(June 2007), DePuy Ireland UC has compiled a Bundled Traditional 510(k)<br>Premarket Notification to modify labeling to include updated MRI<br>compatibility information for DePuy, ATTUNE™ Cementless Knee System<br>(K140881). Updates include modernizing and standardizing the language of<br>the Instructions for Use (IFU) and labels. |
| Device description | A Total Knee Prosthesis is composed of individually packaged femoral, tibial<br>and patellar components designed to replace the natural articular surface of the<br>knee joint. The femoral component is a metal implant with or without a porous<br>coating. The tibial component may be an all polyethylene component or<br>comprised of a metal tibial base without porous coating, and a polyethylene<br>insert and locking components. The patella component may be of an all<br>polyethylene design. |
| Intended use of the device | Total knee arthroplasty is intended to provide increased patient mobility and<br>reduced pain by replacing the damaged knee joint articulation in patients where<br>there is evidence of sufficient sound bone to seat and support the components.<br>Total knee replacement may be considered for younger patients if, in the<br>opinion of the surgeon, an unequivocal indication for total knee replacement<br>outweighs the risks associated with the age of the patient, and if limited<br>demands regarding activity and knee joint loading can be assured. This includes<br>severely crippled disabled patients with multiple joint involvement for whom a<br>gain in knee mobility may lead to an expectation of significant improvement in<br>the quality of their lives. |
| Indications for use | The ATTUNE™ Cementless CR and PS Femoral Components are intended<br>for cementless use within the ATTUNE™ Total Knee Replacement System.<br>Candidates for total knee replacement include patients with a severely<br>painful and/or severely disabled joint resulting from osteoarthritis, post-<br>traumatic arthritis, or a failed previous implant (provided that adequate bone<br>is present). |
| Substantial Equivalence | There are no changes in design, manufacturing, principle of operation,<br>indication, or intended use.<br>The only change is the addition of Magnetic Resonance (MR) safety<br>information in the Instructions for Use (IFU) and the update of language in the<br>IFU 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, Ringaskiddy<br>Co. Cork Munster, IRELAND |
| Applicant Contact Telephone | 574-400-6438 |
| Applicant Contact | Meagan Robles |
| Applicant Contact Email | [e-mail] |

{10}------------------------------------------------

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 Contact<br>Telephone | 574-400-6438 |
| Correspondent Contact | Meagan Robles |
| Correspondent Contact<br>Email | [e-mail] |
| 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 Prosthesis<br>21 CFR 888.3560 - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained<br>cemented prosthesis<br>21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented<br>prosthesis |
| 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,<br>Polymer/Metal/Polymer |
| | MBH: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained,<br>Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| | KRO: Prosthesis, Knee, Femorotibial, Constrained, Cemented,<br>Metal/Polymer…