(312 days)
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, rheumatoid arthritis, or a failed previous implant (provided that adequate bone is present).
The ATTUNE Cementless cruciate retaining (CR) and posterior stabilized (PS) femoral components have an asymmetric trochlear groove and are available in sizes 1-10 in right and left options. Sizes 3-6 are available in standard and narrow options. The fixation surface is porous coated with Porocoat. The porous coated fixation surface comprises: the bone cut surfaces of the anterior flange, anterior chamfer, distal surface, posterior chamfer, posterior condylar resection, as well as the lugs for additional stability. The fixation of the femoral component to the femoral bone is achieved by biologic fixation via ingrowth into the Porocoat porous coating. The ATTUNE femoral components are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. The ATTUNE Cementless CR Femoral Components are compatible with the ATTUNE CR Fixed Bearing inserts (K101433), fixed bearing tibial bases (K101433), and patellae (K103756). The ATTUNE Cementless PS Femoral Components are compatible with the ATTUNE PS Fixed Bearing inserts (K111433), fixed bearing tibial bases (K101433), and patellae (K103756). The ATTUNE CR Total Knee is designed to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knee flexion. The ATTUNE PS Total Knee is designed to accommodate knee flexion to 145 degrees in those patients able to attain a high degree of knee flexion.
This document pertains to the 510(k) premarket notification for the ATTUNE® Knee System-Cementless CR and PS Femoral Components. It describes the device and its substantial equivalence to predicate devices, focusing on the lack of need for new studies rather than describing the acceptance criteria or studies of the device itself.
Based on the provided text, there is no information available regarding acceptance criteria or a study that proves the device meets those acceptance criteria for the ATTUNE® Knee System-Cementless CR and PS Femoral Components.
The document explicitly states:
- "Non-Clinical Testing: None provided as it was not necessary to determine substantial equivalence between the ATTUNE Cementless CR and PS Femoral Components and the predicate devices. As the coating for the subject device is identical to that in K062654, the characterization in K062654 also applies to this 510(k)." (Page 6)
- "Clinical Testing: None provided as it was not necessary to determine substantial equivalence between the ATTUNE Cementless CR and PS Femoral Components and the predicate devices." (Page 6)
The submission argues for substantial equivalence based on existing predicate devices:
- The ATTUNE Cementless CR and PS Femoral Components are "identical in design to the ATTUNE CR and PS Femoral Components cleared for cemented use only in K101433 and K111433."
- "The Porocoat porous coating of the ATTUNE Cementless CR and PS Femoral Components is identical to the Porocoat porous coating used on the SIGMA CR Porocoat Femoral Components cleared for Cementless use in K062654."
Therefore, I cannot provide the requested information from the given text as it explicitly states that new testing was not performed for this 510(k) submission.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected and appear to be a single, continuous line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
DePuy Orthopaedics Incorporated Ms. Nancy Friddle Senior Project Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46581
February 13, 2015
Re: K140881 Trade/Device Name: ATTUNE® Knee System-Cementless CR and PS Femoral Components Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: January 12, 2015 Received: January 13, 2015
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
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Page 2 - Ms. Nancy Friddle
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE
510(k) Number (if known): K140881
Device Name: ATTUNE Knee System – Cementless CR and PS Femoral Components
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, rheumatoid arthritis, or a failed previous implant (provided that adequate bone is present).
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
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Summary of Safety and Effectiveness ATTUNE Total Knee System – Cementless CR and PS Femoral Components DePuy Orthopaedics, Inc.
| Submitted by: | DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, IN 46581Phone: (574) 371-4923Fax: (574) 371-4987 |
|---|---|
| Contact Person: | Nancy Friddle, Sr. Project Manager, Regulatory Affairs |
| Date Prepared: | April 4, 2014 |
| Proprietary Name: | ATTUNE® Knee System – Cementless CR and PS FemoralComponents |
| Common Name: | Total Knee Replacement Prosthesis |
| Classification Name: | 21 CFR 888.3560 Knee joint patellofemorotibial polymer/metal/polymersemi-constrained cemented prosthesis.21 CFR 888.3565 Knee joint patellofemorotibial polymer/metal porouscoated uncemented prosthesis. |
| Product Code: | JWHMBH |
| Predicate Devices: | The ATTUNE Cementless CR and PS Femoral Components, which arepart of the DePuy ATTUNE Knee System, are substantially equivalent tocurrently marketed devices including:• ATTUNE Knee System - CR Femoral Components, K101433• ATTUNE Knee System - PS Femoral Components, K111433• SIGMA CR Porocoat Femoral Components, K062654 |
| Device Description: | The ATTUNE Cementless cruciate retaining (CR) and posterior stabilized(PS) femoral components have an asymmetric trochlear groove and areavailable in sizes 1-10 in right and left options. Sizes 3-6 are available instandard and narrow options. The fixation surface is porous coatedwith Porocoat. The porous coated fixation surface comprises: the bonecut surfaces of the anterior flange, anterior chamfer, distal surface, |
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posterior chamfer, posterior condylar resection, as well as the lugs for additional stability. The fixation of the femoral component to the femoral bone is achieved by biologic fixation via ingrowth into the Porocoat porous coating. The ATTUNE femoral components are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. The ATTUNE Cementless CR Femoral Components are compatible with the ATTUNE CR Fixed Bearing inserts (K101433), fixed bearing tibial bases (K101433), and patellae (K103756). The ATTUNE Cementless PS Femoral Components are compatible with the ATTUNE PS Fixed Bearing inserts (K111433), fixed bearing tibial bases (K101433), and patellae (K103756). The ATTUNE CR Total Knee is designed to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knee flexion. The ATTUNE PS Total Knee is designed to accommodate knee flexion to 145 degrees in those patients able to attain a high degree of knee flexion. Total knee replacement is intended to provide increased patient Intended Use: 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 Total Knee is designed to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knee flexion. 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. Indications for Use: The ATTUNE Cementless CR and PS Femoral Components are intended for cementless use as the femoral components of the ATTUNE Knee 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 tables, the technological characteristics of the ATTUNE Cementless CR and PS femoral components are similar to the predicate devices including design and material.
(provided that adequate bone is present).
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| Characteristic | ATTUNE Cementless CR &PS Femoral Components | ATTUNE (Cemented) CRFemoral Component(K101433)ATTUNE (Cemented) PSFemoral Component(K111433) |
|---|---|---|
| Material | Cast Co-Cr-Mo alloyconforming to ASTM F75 | Cast Co-Cr-Mo alloyconforming to ASTM F75 |
| Sizes | Sizes 1 to 10 standard, Leftand RightSizes 3-6 narrow, Left andRightProportional Sizing | Sizes 1 to 10 standard, Leftand RightSizes 3-6 narrow, Left andRightProportional Sizing |
| FixationSurface | Porocoat | Cemented |
| Characteristic | ATTUNE Cementless CR &PS Femoral Components | SIGMA CR PorocoatFemoral Components(K062654) |
|---|---|---|
| Material | Cast Co-Cr-Mo alloyconforming to ASTM F75 | Cast Co-Cr-Mo alloyconforming to ASTM F75 |
| FixationSurface | Porocoat | Porocoat |
Summary of
Substantial
Equivalence:
The ATTUNE Cementless CR and PS Femoral Components are identical in design to the ATTUNE CR and PS Femoral Components cleared for cemented use only in K101433 and K111433. The Porocoat porous coating of the ATTUNE Cementless CR and PS Femoral Components is identical to the Porocoat porous coating used on the SIGMA CR Porocoat Femoral Components cleared for Cementless use in K062654.
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Non-Clinical Testing:
None provided as it was not necessary to determine substantial equivalence between the ATTUNE Cementless CR and PS Femoral Components and the predicate devices. As the coating for the subject device is identical to that in K062654, the characterization in K062654 also applies to this 510(k).
Clinical Testing:
None provided as it was not necessary to determine substantial equivalence between the ATTUNE Cementless CR and PS Femoral Components and the predicate devices.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.