DEPUY ATTUNE TOTAL KNEE SYSTEM

K103756 · DePuy Orthopaedics, Inc. · OIY · Mar 15, 2011 · Orthopedic

Device Facts

• Record ID: K103756
• Device Name: DEPUY ATTUNE TOTAL KNEE SYSTEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: OIY · Orthopedic
• Decision Date: Mar 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Total knee replacement 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. The Attune CR Knee System is intended to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knee flexion. The DePuy Attune™ Total Knee System is intended for cemented use as a total knee replacement system. Candidates for total knee replacement include patients with a severely painful and/ or severely disabled joint resulting from osteoarthritis, posttraumatic arthritis, rheumatoid arthritis, or a failed previous implant.

Device Story

DePuy Attune Total Knee System; medialized dome and medialized anatomic patellae components. Replaces damaged knee joint articulation to improve mobility and reduce pain. Components feature 3-peg fixation surface with recessed cement pockets for cemented implantation. Manufactured from AOX ultra-high molecular weight polyethylene (UHMWPE). Designed to accommodate knee flexion up to 150 degrees. Used by orthopedic surgeons in clinical/surgical settings. Provides stable articular surface offset medially to match patient anatomy. Benefits patients by restoring joint function and alleviating pain associated with arthritis or failed prior implants.

Clinical Evidence

No clinical data provided; substantial equivalence determined via bench testing. Functional testing performed in compliance with FDA guidance for knee joint patellofemorotibial prostheses to verify implant performance via constraint and contact tests.

Technological Characteristics

Materials: AOX UHMWPE (ASTM F648). Fixation: Cemented, 3-peg design with recessed cement pockets. Sizes: 29, 32, 35, 38, 41 mm. Articular surface: Medially offset. Form factor: Patellar component for total knee arthroplasty.

Indications for Use

Indicated for patients with severely painful and/or disabled knee joints due to osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implants, requiring total knee replacement with sufficient bone stock for component seating.

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

• Sigma Patella (K950010)
• PFC Cruciate Retaining Knee System (K961685)
• Attune Modified Dome Patella (K101433)
• Kinemax Plus Patella (K910500)
• Zimmer NexGen CR Knee System (K933785)

Submission Summary (Full Text)

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K103756

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# 510(k) Summary

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# MAR 1 5 2011

| Submitted by: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, IN 46581<br>Phone: [phone]<br>Fax: [phone] |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Nancy Friddle, Project Manager Regulatory Affairs |
| Date Prepared: | December 2, 2010 |
| Proprietary Name: | DePuy Attune™ Total Knee System |
| Common Name: | Total Knee Replacement Prosthesis |
| Classification Name: | 21 CFR 888.3560 Knee joint patellofemorotibial<br>polymer/metal/polymer semi-constrained cemented prosthesis.<br>Class II |
| Product Code: | JWH<br>OIY |
| Predicate Devices: | The DePuy Attune Medialized Dome and Medialized Anatomic<br>Patellae are substantially equivalent to currently marketed devices<br>including:<br>• Sigma Patella (cleared as the Darwin Knee System), K950010<br>• PFC Cruciate Retaining Knee System, Size 1.5, K961685<br>• Attune Modified Dome Patella, K101433<br>• Kinemax Plus Patella, K910500<br>• Zimmer NexGen CR Knee System, K933785 |
| Device Description: | The Attune medialized dome and medialized anatomic patellae are<br>available in sizes 29, 32, 35, 38, and 41mm. The fixation surface<br>incorporates 3 pegs to provide stability and recessed cement pockets<br>for enhanced cement fixation. The patella components are<br>manufactured from AOX ultra high molecular weight polyethylene<br>conforming to ASTM F648. The articular surface is offset medially<br>proportional to the size of the component.<br>The Attune CR Knee System is designed to accommodate knee<br>flexion to 150 degrees in those patients able to attain a high degree<br>of knee flexion. |
| Intended Use: | Total knee replacement is intended to provide increased patient |

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K103756 *2/3

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.

The Attune CR Knee System is intended to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knee flexion.

The DePuy Attune™ Total Knee System is intended for cemented use as a Indications for Use: total knee replacement system.

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

### Technological Characteristics:

As shown in the following table, the technological characteristics of the Attune medialized dome and medialized anatomic patellae are similar to the predicate devices including design and AOX material.

| Characteristic | Attune Medialized<br>Dome and Medialized<br>Anatomic Patella<br>(current submission) | Sigma 3-Peg Oval Patella (K961685, K950010)<br>Attune Modified Dome Patella (K101433)<br>NexGen Patella (K933785)<br>Kinemax Plus Patella (K910500) |
|-----------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | AOX UHMWPE<br>conforming to ASTM<br>F648 | Attune: AOX UHMWPE conforming<br>to ASTM F648 |
| Sizes | 29, 32, 35, 38, 41 mm | Attune: 29, 32, 35, 38, 41mm<br>Sigma: 32 (K961685)<br>35, 38, 41mm (K950010)<br>NexGen: 29, 32, 35, 38, 41mm (standard<br>sizes) |
| Articular Surface<br>Offset | medial | Kinemax: medial |
| Fixation Surface | Cemented | Sigma: Cemented |

Summary of Substantial Equivalence:

As part of the Attune CR total knee replacement system, the DePuy Attune medialized dome and medialized anatomic patellae are

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K103756#3/3

substantially equivalent to currently marketed devices as demonstrated with preclinical data.

#### Non-Clinical Testing:

Functional testing was conducted in compliance with FDA guidance, Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA, to verify that the implant performance would be substantially equivalent to predicate devices for anticipated in vivo loading via constraint and contact tests.

#### Clinical Testing:

None provided as it was not necessary to determine substantial equivalence between the Attune Knee System's medialized dome and medialized anatomic patellae and the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes extending from its back, all enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the border of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DePuy Orthopaedics. Inc. % Ms. Nancy Friddle Project Manager Regulatory Affairs 700 Orthopacdic Drive Warsaw, Indiana 46581

MAR 1 5 2011

Re: K103756

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 Dated: December 22, 2010 Received: December 23, 2010

Dear Ms. Friddle:

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. The general controls provisions of the Act include requirements for annual registration. Iisting 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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Page 2 -- Ms. Nancy Friddle

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Afy B. Rh

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 2. INDICATIONS FOR USE

K103756 510(k) Number (if known): _

Device Name: DePuy Attune™ Medialized Dome and Medialized Anatomic Patellae

Indications for Use:

The DePuy Attune™ Total Knee System is intended for cemented use as a 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, theumatoid arthritis, or a failed previous implant.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

for M. Mulberson

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K103756
510(k) Number