(90 days)
Candidates for total knee replacement include patients with a severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.
The ATTUNE Cemented Tibial Base, Fixed Bearing (FB) are available in sizes 1-10. The fixation surface incorporates a stem and keel to provide additional stability as well as recessed undercut cement pockets and a grit blasted surface for enhanced cement fixation. The tibial base utilizes a central universal locking mechanism to capture the tibial insert. The ATTUNE Cemented Tibial Base, FB is manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. Additionally, the ATTUNE Cemented Tibial Base, FB utilizes a previously cleared Base Protector assembled with the device to minimize potential marring of the proximal bearing surface of the tibial base during impaction. After impaction is completed, the Base Protector is then removed and discarded prior to inserting the ATTUNE Fixed Bearing Insert.
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 describes the premarket notification (510(k)) for the ATTUNE Cemented Tibial Base, Fixed Bearing, a component of a total knee replacement system. The application seeks to demonstrate substantial equivalence to previously cleared predicate devices.
Acceptance Criteria and Device Performance (based on provided text):
The acceptance criteria are implicitly derived from the successful completion of the non-clinical tests and the product's ability to maintain performance comparable to its predicate devices. The study concludes that the device meets these criteria by demonstrating substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Devices: Device performance is substantially equivalent to predicate devices for anticipated in-vivo loading. | Successful Functional Testing: The device successfully passed the following tests, verifying substantial equivalence for in-vivo loading: - Fatigue Testing per ASTM F 1800 (Cyclic Testing of Metal Tibial Tray Components) - Intraoperative Range of Motion (ROM) simulation and pull-off testing with lipid and marrow - Surgeon validation |
| Biocompatibility: Device materials are biocompatible. | Inherently Met: The device uses the same materials as the previously cleared ATTUNE Cemented Tibial Base (K101433) and is stated to have the same biocompatibility. |
| Bacterial Endotoxin Levels: Device meets bacterial endotoxin requirements. | Successful Bacterial Endotoxin Testing: The proposed devices meet the requirement of Bacterial endotoxin testing as specified in ANSI AAMI ST-72:2011. |
| Manufacturing, Packaging, Sterilization: Methods are consistent with predicate devices. | Inherently Met: The device has the same manufacturing methods, packaging configurations, and sterilization methods as the previously cleared ATTUNE Cemented Tibial Base (K101433). |
| Indications & Intended Use: Consistent with predicate devices. | Inherently Met: The device has the same indications and intended use as the previously cleared ATTUNE Cemented Tibial Base (K101433). |
Detailed Study Information:
-
Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes (e.g., number of units tested) for the non-clinical tests (Fatigue Testing, ROM/pull-off testing, bacterial endotoxin testing).
- Data provenance: The testing was "non-clinical" and appears to be experimental, rather than based on patient data. This is typically laboratory or bench testing. No country of origin for the data is explicitly mentioned, but the submitter is based in Indiana, USA. The study is not retrospective or prospective in the sense of patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document mentions "Surgeon validation" as part of the non-clinical testing. However, it does not specify the number of surgeons, their qualifications, or how their "validation" contributed to establishing a "ground truth" in the context of the device's functional integrity. In this type of device submission, "surgeon validation" typically refers to confirmation of usability or fit, not necessarily establishing a clinical ground truth like in diagnostic AI.
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Adjudication method for the test set:
- Not applicable. This is a non-clinical, bench-top and materials testing study, not a study involving human readers or cases needing adjudication.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done. This document describes a submission for a knee implant component, not an AI or diagnostic device that would involve human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical/material device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by engineering and biomechanical standards (e.g., ASTM F1800, ANSI AAMI ST-72:2011) and by comparison to the established performance of legally marketed predicate devices. The "truths" are determined by adherence to these standards and demonstrated equivalence in functional testing.
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The sample size for the training set:
- Not applicable. This is a medical device (implant component) submission, not an AI or machine learning device that requires a training set. The device itself is the product being evaluated.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
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Public Health Service
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 15, 2017
DePuy (Ireland) Nancy Friddle Associate Director, Regulatory Affairs DePuv Orthopaedics. Inc. 700 Orthopaedic Dr. Warsaw, Indiana 46582
Re: K170806
Trade/Device Name: ATTUNE Cemented Tibial Base, Fixed Bearing Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, OIY Dated: March 16, 2017 Received: March 17, 2017
Dear Nancy 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
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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 devicerelated 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 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" (21 CFR 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,
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for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170806
Device Name
ATTUNE Cemented Tibial Base, Fixed Bearing
Indications for Use (Describe)
Candidates for total knee replacement include patients with a 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) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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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 DriveWarsaw, IN 46582 |
| Phone number | (574) 371-4923 |
| Fax number | (574) 371-4987 |
| Establishment | 1818910 |
| Registration Number | |
| Name of contact person | Nancy Friddle |
| Date prepared | March 16, 2016 |
| Name of device | |
| Trade or proprietary name | ATTUNE Cemented Tibial Base, Fixed Bearing |
| Common or usual name | Total Knee Prosthesis |
| Classification name | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.3560 |
| Product Code(s) | OIY, JWH |
| Legally marketeddevice(s) to whichequivalence is claimed | Primary Predicate:K101433: DePuy ATTUNE Knee SystemReference Predicate:K032151: Sigma Co-Cr Tibial Trays |
| Reason for 510(k)submission | Addition of a new Cemented Tibial Base component to the ATTUNEKnee System |
| Device description | The ATTUNE Cemented Tibial Base, Fixed Bearing (FB) areavailable in sizes 1-10. The fixation surface incorporates a stemand keel to provide additional stability as well as recessed undercutcement pockets and a grit blasted surface for enhanced cementfixation. The tibial base utilizes a central universal lockingmechanism to capture the tibial insert. The ATTUNE CementedTibial Base, FB is manufactured from cast Co-Cr-Mo alloyconforming to ASTM F75. Additionally, the ATTUNE CementedTibial Base, FB utilizes a previously cleared Base Protectorassembled with the device to minimize potential marring of theproximal bearing surface of the tibial base during impaction. Afterimpaction is completed, the Base Protector is then removed anddiscarded prior to inserting the ATTUNE Fixed Bearing Insert.The ATTUNE CR Total Knee is designed to accommodate kneeflexion to 150 degrees in those patients able to attain a high degree ofknee flexion. |
| The ATTUNE PS Total Knee is designed to accommodate kneeflexion to 145 degrees in those patients able to attain a high degree ofknee flexion. | |
| Intended use of thedevice | Total knee arthroplasty is intended to provide increased patientmobility and reduced pain by replacing the damaged knee jointarticulation in patients where there is evidence of sufficient soundbone to seat and support the components. Total knee replacementmay be considered for younger patients if, in the opinion of thesurgeon, an unequivocal indication for total knee replacementoutweighs the risks associated with the age of the patient, and iflimited demands regarding activity and knee joint loading can beassured. This includes severely crippled patients with multiple jointinvolvement for whom a gain in knee mobility may lead to anexpectation of significant improvement in the quality of their lives. |
| Indications for use | Candidates for total knee replacement include patients with aseverely painful and/or severely disabled joint resulting fromosteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or afailed previous implant. |
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Summary of Technologies/ Substantial Equivalence Discussion:
The ATTUNE Cemented Tibial Base, FB provides a macro geometric feature and an optimized micro-blast finish which are both intended to aid in fixation of the tibial implant to the bone cement. The ATTUNE Cemented Tibial Base, FB is designed to enhance fixation by improving resistance (relative to the industry) to intra-operative factors which can result in a reduction in cement to implant bond.
The subject ATTUNE Cemented Tibial Base, FB has the same indications, intended used, materials, biocompatibility, packaging configurations, manufacturing methods, and sterilization methods as the previously cleared ATTUNE Cemented Tibial Base (K101433). The subject ATTUNE Cemented Tibial Base, FB is manufactured with undercut cement pockets similar to those previously cleared with the Sigma Co-Cr Trays (K032151).
The testing provided below was used to support equivalence to the predicate devices.
| Non-Clinical Testing: | Functional testing was conducted in compliance with FDA Guidance,Class II Special Controls Guidance Document: Knee JointPatellofemorotibial and Femorotibial Metal/Polymer Porous-CoatedUncemented Prostheses: Guidance for Industry and FDA, to verifythat the implant performance is substantially equivalent to predicatedevices for anticipated in-vivo loading via the following tests:Fatigue Testing per ASTM F 1800, Standard Practice forCyclic Testing of Metal Tibial Tray Components of Total |
|---|---|
| ----------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| Knee Joint Replacements | |
|---|---|
| Intraoperative ROM simulation and pull-off testing with lipid● | |
| and marrow | |
| Surgeon validation● | |
| The proposed devices also meet the requirement ofBacterial endotoxin testing as specified in ANSI AAMI ST-●72:2011. | |
| Clinical Testing: | Clinical testing was not necessary to determine substantialequivalence between the ATTUNE Cemented Tibial Base, FB andthe predicate devices. |
| Conclusions drawnfrom non-clinical andclinical data | The subject Fixed Bearing ATTUNE Cemented Tibial Base, FB issubstantially equivalent to the predicate Fixed Bearing ATTUNETotal Knee System Tibial Bases and Sigma Co-Cr Tibial Trays. |
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
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).(b)
Classification. Class II.