(90 days)
No
The 510(k) summary describes a mechanical knee implant and its materials and testing, with no mention of AI or ML.
Yes
The device is described as a "Total Knee" replacement, used for patients with severely disabled knee joints due to various arthritic conditions or failed previous implants, indicating its purpose is to treat or alleviate a medical condition.
No
Explanation: The device described is a total knee replacement implant, specifically a tibial base. Its purpose is to replace a diseased or damaged knee joint component, which is a therapeutic function, not a diagnostic one. The "Intended Use / Indications for Use" section clearly states it's for patients with severely disabled joints "resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant," indicating a treatment purpose.
No
The device description clearly describes a physical implant (tibial base) made of Co-Cr-Mo alloy, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes the device as a component for total knee replacement surgery in patients with severely disabled knee joints. This is a surgical implant, not a diagnostic test performed on samples from the body.
- Device Description: The description details the physical characteristics, materials, and function of a tibial base component for a knee replacement. It does not describe any process for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample to diagnose a condition or provide information about a patient's health status.
- Anatomical Site: The device is used directly within the knee joint, not for testing samples taken from the body.
In summary, the ATTUNE Cemented Tibial Base, Fixed Bearing is a surgical implant used to replace a damaged knee joint, which is a completely different category of medical device than an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JWH, OIY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 is substantially equivalent to predicate devices for anticipated in-vivo loading via the following tests:
Fatigue Testing per ASTM F 1800, Standard Practice for Cyclic Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
Intraoperative ROM simulation and pull-off testing with lipid and marrow
Surgeon validation
The proposed devices also meet the requirement of Bacterial endotoxin testing as specified in ANSI AAMI ST-72:2011.
Clinical Testing: Clinical testing was not necessary to determine substantial equivalence between the ATTUNE Cemented Tibial Base, FB and the predicate devices.
Conclusions: The subject Fixed Bearing ATTUNE Cemented Tibal Base, FB is substantially equivalent to the predicate Fixed Bearing ATTUNE Total Knee System Tibial Bases and Sigma Co-Cr Tibial Trays.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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 Drive |
| Warsaw, 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 marketed | |
| device(s) to which | |
| equivalence is claimed | Primary Predicate: |
| K101433: DePuy ATTUNE Knee System | |
| Reference Predicate: | |
| K032151: Sigma Co-Cr Tibial Trays | |
| Reason for 510(k) | |
| submission | Addition of a new Cemented Tibial Base component to the ATTUNE |
| Knee System | |
| Device description | 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. |
| Intended use of the
device | Total knee arthroplasty 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. Total knee replacement
may be considered for younger patients if, in the opinion of the
surgeon, an unequivocal indication for total knee replacement
outweighs the risks associated with the age of the patient, and if
limited demands regarding activity and knee joint loading can be
assured. This includes severely crippled patients with multiple joint
involvement for whom a gain in knee mobility may lead to an
expectation of significant improvement in the quality of their lives. |
| 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 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 Joint
Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated
Uncemented Prostheses: Guidance for Industry and FDA, to verify
that the implant performance is substantially equivalent to predicate
devices for anticipated in-vivo loading via the following tests:
Fatigue Testing per ASTM F 1800, Standard Practice for
Cyclic 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 of | |
| Bacterial endotoxin testing as specified in ANSI AAMI ST- | |
| ● | |
| 72:2011. | |
| Clinical Testing: | Clinical testing was not necessary to determine substantial |
| equivalence between the ATTUNE Cemented Tibial Base, FB and | |
| the predicate devices. | |
| Conclusions drawn | |
| from non-clinical and | |
| clinical data | The subject Fixed Bearing ATTUNE Cemented Tibial Base, FB is |
| substantially equivalent to the predicate Fixed Bearing ATTUNE | |
| Total Knee System Tibial Bases and Sigma Co-Cr Tibial Trays. |