DePuy ATTUNE™ Total Knee System

K201347 · DePuy Orthopaedics, Inc. · OIY · Jun 18, 2020 · Orthopedic

Device Facts

• Record ID: K201347
• Device Name: DePuy ATTUNE™ Total Knee System
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: OIY · Orthopedic
• Decision Date: Jun 18, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy Attune Total Knee System is intended for cemented and noncemented use as a total knee replacement system.

Device Story

Total knee replacement system comprising polyethylene tibial inserts and patella components; mates with existing cemented/noncemented femoral and tibial base components. Used by orthopedic surgeons in clinical settings to replace damaged knee joints. Device restores joint function and reduces pain for patients with severe arthritis or failed prior implants. This submission specifically extends the shelf life of AOX polyethylene components from 5 to 8 years; no changes to design, materials, or principle of operation.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including Material Oxidation Index/Resistance Testing (ASTM F2102-17, ASTM F2003) and Wear Testing with Particle Analysis (ISO 14243-2, ISO 14243-3, ASTM F1877-05).

Technological Characteristics

Components manufactured from AOX ultra-high molecular weight polyethylene. Fixed bearing tibial inserts (CR and PS) and patella components. Gamma irradiated. Shelf life extended to 8 years. No changes to materials, sterilization, or design.

Indications for Use

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

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• DePuy ATTUNE Knee System (K101433)
• DePuy ATTUNE PS Knee System (K111433)
• DePuy ATTUNE Medialized Dome and Anatomic Patellae Components (K103756)
• ATTUNE Total Knee System – Cementless CR & PS Femoral Components (K140881)

Submission Summary (Full Text)

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June 18, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right, there is a blue square with the letters "FDA" in white. Next to the square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

Mary Wood Regulatory Affairs Associate DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw. Indiana 46582

Re: K201347

Trade/Device Name: DePuy ATTUNE™ Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: OIY, JWH, MBH Dated: May 13, 2020 Received: May 21, 2020

Dear Mary Wood:

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.

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

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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 (OS) 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 mediation-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).

Sincerely,

**Ting Song -S**

Ting Song, Ph.D., R.A.C. 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) K201347

Device Name ATTUNE Total Knee System

#### Indications for Use (Describe)

The DePuv Attune Total Knee System is intended for cemented use as a total knee replacement system.

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

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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K201347
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# 5. 510k Summary

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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, Indiana 46582 |
| Phone number | 812-219-1298 |
| Fax number | N/A |
| Establishment Registration # | 1818910 |
| Name of contact person | Mary Wood |
| Date prepared | May 8, 2020 |
| Name of device | |
| Trade or proprietary name | ATTUNE™ Total Knee System |
| Common or usual name | Total Knee Arthroplasty Prosthesis |
| Classification name | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained<br>cemented prosthesis |
| | Knee joint patellofemorotibial metal/polymer porous-coated<br>uncemented prosthesis. |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.3560 |
| | 21 CFR 888.3565 |
| Product Code(s) | OIY, JWH, MBH |
| Legally marketed device(s) to which<br>equivalence is claimed | Primary Predicate:<br>DePuy ATTUNE Knee System, K101433 |
| | Reference Predicates:<br>DePuy ATTUNE PS Knee System, K111433 |
| | DePuy ATTUNE Medialized Dome and Anatomic Patellae<br>Components, K103756 |
| | ATTUNE Total Knee System – Cementless CR & PS Femoral<br>Components, K140881 |
| Reason for 510(k)<br>submission | The purpose of this submission is to extend the current approved shelf<br>life of 5 years to 8 years. |
| Device description | The subject device is a polyethylene tibial inserts and patella component<br>made from AOX Polyethylene that mates with existing cemented and<br>noncemented femoral and tibial base components |
| Intended use of the device | The DePuy Attune Total Knee System is intended for cemented and noncemented use as a total knee replacement 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. |

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#### Summary of Technologies/ Substantial Equivalence Discussion

The purpose of this submission is to propose a change in shelf life from 5 years for the ATTUNE AOX Fixed Bearing Tibial Inserts for both CR (Cruciate Retaining) and PS (Posterior Stabilized) as well as the Medialized Dome and Anatomic Patellae components

There are no other modifications associated with the currently marketed products. The intended use, product design, principle of operation and materials are not impacted by this change.

| Non-Clinical Testing: | The following testing was conducted (in compliance with FDA Guidance<br>Class II Special Controls Guidance Document: Knee Joint<br>Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated<br>Uncemented Prostheses: Guidance for Industry and FDA) to demonstrate<br>substantial equivalence of safety and efficacy with the predicate devices:<br>Material Oxidation Index/Resistance Testing (ASTM F2102-17 ASTM F2003) Wear Testing with Particle Analysis (ISO 14243-2, ISO 14243-3 ASTM F1877-05) |
|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Testing: | Clinical testing was not necessary to determine substantial equivalence<br>between the ATTUNE Polyethylene Fixed Bearing Tibia Inserts and<br>Patella components and the predicate devices. |
| Conclusions drawn from<br>non-clinical and clinical<br>data | The subject ATTUNE Polyethylene Fixed Bearing Tibia Inserts and Patella<br>components with 8 year shelf life are substantially equivalent to the<br>predicate ATTUNE Polyethylene Fixed Bearing Tibia Inserts and Patella<br>components with 5 year shelf life. |

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

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Note: There have been no modifications made to the intended use, design, biocompatibility, materials, sterilization or packaging of the existing DePuy ATTUNE Knee System.

The only modification being sought via this Special 510(k) submission is a change in the shelf life of the ATTUNE C/R Fixed Bearing Insert, ATTUNE P/S Fixed Bearing Insert and the ATTUNE Medialized Dome and Anatomic Patellae components which are made from AOX Polyethylene that is gamma irradiated.

The ATTUNE Knee System is not an invitro-diagnostic device.

# Submission Purpose

The purpose of this submission is to propose a change in shelf life from 5 years to 8 years for the ATTUNE AOX Fixed Bearing Tibial Inserts for both CR (Cruciate Retaining) and PS (Posterior Stabilized) as well as the Medialized Dome and Anatomic Patellae components. A complete list of the affected devices is provided as Exhibit A. The change will require an update to the shelf life indicated on the Labeling. Draft labeling is provided as Exhibit B.

There are no other modifications associated with the currently marketed product predicate ATTUNE Total Knee System. The intended use, product design, principle of operation and materials are not impacted by this change.

## Device Description

The ATTUNE CR Fixed Bearing Tibial inserts are available in sizes 1-10 and in thicknesses of 5, 6, 7, 8, 10, 12, 14, 16, and 18mm. They are manufactured from AOX ultra high molecular weight polyethylene.

The ATTUNE PS Fixed Bearing Tibial Inserts are available in sizes 1-10 and in thicknesses of 5, 6, 7, 8, 10, 12, 14, 16, 18, 20, and 22mm. They are manufactured from AOX ultra high molecular weight polyethylene.

The ATTUNE Medialized Dome and Medialized Anatomic Patellae are available in sizes 29, 32, 35, 38. and 41mm. They are manufactured from AOX ultra high molecular weight polyethylene.

The proposed change to the shelf life of the subject AOX components will have no impact to the predicate, ATTUNE Knee System (K101433, K111433, K103756, K140881) which are intended for both cemented and noncemented use.

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## Materials

The subject ATTUNE Fixed Bearing Tibial Inserts and Patellae components are manufactured from AOX Polyethylene. This change proposes a shelf life change from 5 to 8 years; no material or sterilization changes are proposed.

### Design

No design changes are proposed for this submission. The change is to extend the shelf life of the existing ATTUNE AOX Fixed Bearing Tibial Inserts and Patellae components from 5 years to 8 years.