DEPUY STTUNE (TM) PS KNEE SYSTEM

K111433 · DePuy Orthopaedics, Inc. · OIY · Aug 30, 2011 · Orthopedic

Device Facts

• Record ID: K111433
• Device Name: DEPUY STTUNE (TM) PS KNEE SYSTEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: OIY · Orthopedic
• Decision Date: Aug 30, 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 PS Total Knee is intended to accommodate knee flexion to 145 degrees in those patients able to attain a high degree of knee flexion.

Device Story

DePuy Attune PS Knee System is a total knee replacement prosthesis consisting of posterior stabilized (PS) femoral components and PS fixed bearing tibial inserts. Femoral components feature asymmetric trochlear grooves, textured fixation surfaces, and two lugs for cement fixation. Tibial inserts utilize multi-radii topography to balance anterior constraint and posterior rollback. Components are implanted by orthopedic surgeons in a clinical setting to replace damaged knee joints, aiming to restore mobility and reduce pain. The system accommodates up to 145 degrees of knee flexion. The device is intended for cemented use.

Clinical Evidence

No clinical data provided; substantial equivalence determined via bench testing in compliance with FDA guidance for knee joint prostheses.

Technological Characteristics

Femoral components: Cast Co-Cr-Mo alloy (ASTM F75). Tibial inserts: AOX ultra-high molecular weight polyethylene (ASTM F648). Design features: Asymmetric trochlear groove, textured fixation surface, recessed cement pockets. Fixation: Cemented. Sizes: 1-10 (femoral and tibial).

Indications for Use

Indicated for cemented total knee replacement in patients with severely painful and/or disabled joints due to osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implants.

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

• Attune Knee System (K101433)
• Sigma Tibial Inserts (K033272)
• Sigma XLK Tibial Inserts (K040166)
• Sigma PS Femoral Components (K073529)
• Zimmer NexGen LPS Femoral Components / Articular Surfaces (K960279)

Reference Devices

• Attune FB tibial bases (K101433)
• Attune patellae (K103756)

Submission Summary (Full Text)

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K111M33 #'/4

AUG 3 0 2011

### Summary of Safety and Effectiveness Attune Total Knee System – PS Femoral Components and PS Fixed Bearing Inserts DePuy Orthopaedics

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| 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: | May 16, 2011 |
| Proprietary Name: | DePuy Attune™ 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 PS Femoral Components and PS Fixed Bearing<br>Inserts, which are part of the DePuy Attune Knee System, are<br>substantially equivalent to currently marketed devices including:<br>• Attune Knee System, K101433<br>• Sigma Tibial Inserts, K033272<br>• Sigma XLK Tibial Inserts, K040166<br>• Sigma PS Femoral Components, K073529<br>• Zimmer NexGen LPS Femoral Components / Articular<br>Surfaces, K960279 |
| Device Description: | The Attune™ posterior stabilized (PS) femoral components have an<br>asymmetric trochlear groove and are available in sizes 1-10 in right<br>and left options. Sizes 3-6 are available in standard and narrow<br>options. The fixation surface is textured. It incorporates two lugs<br>(pegs) to provide additional stability and recessed cement pockets for<br>enhanced cement fixation. The Attune femoral components are<br>manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. |
| | The Attune PS fixed bearing tibial insert is designed with a<br>topography that, in the sagittal view, consists of multiple radii. The<br>sagittal anterior radii are relatively conforming to the femoral<br>component to aid in anterior constraint while the posterior radius is<br>less conforming to allow rollback. The Attune PS fixed bearing tibial<br>inserts are available in sizes 1-10 and in thicknesses of 5, 6, 7, 8, 10,<br>12, 14, 16, 18, 20, and 22mm. The inserts are manufactured from<br>AOX ultra high molecular weight polyethylene conforming to ASTM<br>F648. |
| | The Attune PS femoral components and PS fixed bearing inserts are<br>compatible with the Attune FB tibial bases (K101433) and patellae<br>(K103756). |
| | The Attune PS Total Knee is designed to accommodate knee flexion<br>to 145 degrees in those patients able to attain a high degree of knee<br>flexion. |
| Intended Use: | Total knee replacement is intended to provide increased patient<br>mobility and reduced pain by replacing the damaged knee joint<br>articulation in patients where there is evidence of sufficient sound<br>bone to seat and support the components. |
| | The Attune PS Total Knee is intended to accommodate knee flexion<br>to 145 degrees in those patients able to attain a high degree of knee<br>flexion. |
| Indications for Use: | As part of the DePuy Attune Knee System, the DePuy Attune PS<br>femoral components and tibial inserts are intended for cemented use<br>as a total knee replacement system.<br><br>Candidates for total knee replacement include patients with a severely<br>painful and/or severely disabled joint resulting from osteoarthritis,<br>post-traumatic arthritis, rheumatoid arthritis, or a failed previous<br>implant. |
| Technological<br>Characteristics: | As shown in the following tables, the technological characteristics of<br>the Attune PS femoral components and tibial inserts are similar to<br>the predicate devices including design and material. |

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K1114.33 *2/4

| Characteristic | Attune PS Femoral<br>Component | Attune CR Femoral<br>Component (K101433) |
|----------------|-----------------------------------------------|-----------------------------------------------|
| Material | Cast Co-Cr-Mo alloy<br>conforming to ASTM F75 | Cast Co-Cr-Mo alloy<br>conforming to ASTM F75 |

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| Characteristic | Attune PS Femoral<br>Component | Attune CR Femoral<br>Component (K101433) |
|---------------------|-------------------------------------------|-------------------------------------------|
| Sizes | Sizes 1 to 10 standard, Left<br>and Right | Sizes 1 to 10 standard, Left<br>and Right |
| | Sizes 3-6 narrow, Left and<br>Right | Sizes 3-6 narrow, Left and<br>Right |
| | Proportional Sizing | Proportional Sizing |
| Fixation<br>Surface | Cemented | Cemented |

| Characteristic | Attune PS Fixed Bearing<br>Tibial Inserts | Attune CR Fixed Bearing<br>Tibial Inserts (K101433) and<br>Sigma Tibial Inserts<br>(K033272) |
|----------------|----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | AOX UHMWPE conforming<br>to ASTM F648 | Attune CR: AOX UHMWPE<br>conforming to ASTM F648 |
| Sizes | Proportional sizing<br>PS inserts, sizes 1 to 10<br>Actual thicknesses 5, 6, 7, 8,<br>10, 12, 14, 16, 18, 20, and<br>22mm. | Attune CR:<br>Proportional sizing<br>CR inserts, sizes 1 to 10<br>Actual thicknesses 5, 6, 7, 8,<br>10, 12, 14, 16, and 18mm.<br><br>Sigma Stabilized:<br>Constant sizing<br>Stabilized inserts, sizes 1.5 to 6<br>Composite thicknesses 8, 10,<br>12.5, 15, 17.5, 20, 22.5 and<br>25mm. |

Summary of Substantial Equivalence:

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The DePuy Attune Total Knee System is substantially equivalent to currently marketed devices as demonstrated with preclinical data.

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K111433*4/4

### 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 various constraint, contact, wear, and fatigue tests.

#### Clinical Testing:

None provided as it was not necessary to determine substantial equivalence between the Attune Knee System's PS femoral and PS fixed bearing insert components and the predicate devices.

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

DePuy Orthopaedics, Inc. % Ms. Nancy Friddle 700 Orthopaedic Drive Warsaw, Indiana 46581

AUG 3 0 2011

Re: K111433 Trade/Device Name: DePuy Attune™ PS Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: OIY, JWH Dated: August 10, 2011 Received: August 11, 2011

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, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Ms. Nancy Friddle

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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

urs,
For Pati

Der

Cli

B.N

Mark N. Melkerso 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

KU11433 510(k) Number (if known): _

Device Name: DePuy Attune™ PS Knee System

Indications for Use:

The DePuy Attune™ 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 osteo.arthritis, post-traumatic arthritis, rheumatoid 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.Mellerson

(Division Sign-Oft) (Division Sign-on) )
Division of Surgical, Orthopedic, Division of Surgices

510(k) Number K111433.