(28 days)
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 and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.
The subject device is a polyethylene tibial inserts and patella component made from AOX Polyethylene that mates with existing cemented and noncemented femoral and tibial base components
The provided text does not describe an AI medical device or a study involving AI. It is a 510(k) submission for a Total Knee System and specifically concerns an extension of the product's shelf life (from 5 years to 8 years) for certain components made from AOX Polyethylene that are gamma irradiated.
Therefore, I cannot extract information related to:
- Acceptance criteria for an AI device.
- Sample size for a test set or data provenance for an AI study.
- Number of experts for ground truth establishment for an AI study.
- Adjudication method for an AI study.
- Multi-reader multi-case (MRMC) comparative effectiveness study for AI.
- Standalone performance for an AI algorithm.
- Type of ground truth for an AI study.
- Sample size for a training set for AI.
- How ground truth for a training set was established for AI.
The document discusses non-clinical testing to support the shelf-life extension, specifically:
- Material Oxidation Index/Resistance Testing (ASTM F2102-17, ASTM F2003)
- Wear Testing with Particle Analysis (ISO 14243-2, ISO 14243-3, ASTM F1877-05)
It explicitly states: "Clinical testing was not necessary to determine substantial equivalence between the ATTUNE Polyethylene Fixed Bearing Tibia Inserts and Patella components and the predicate devices."
In summary, the provided text does not contain the information requested as it pertains to a mechanical medical device (knee implant) and a shelf-life extension, not an AI device or an AI study.
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June 18, 2020
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Mary Wood Regulatory Affairs Associate DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw. Indiana 46582
Re: K201347
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, MBH Dated: May 13, 2020 Received: May 21, 2020
Dear Mary Wood:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ting Song -S
Ting Song, Ph.D., R.A.C. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201347
Device Name ATTUNE Total Knee System
Indications for Use (Describe)
The DePuv Attune Total Knee System is intended for cemented use as a total knee replacement system.
Candidates for total knee replacement include patients with and/or 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K201347
Page 1 of 5
5. 510k Summary
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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, Indiana 46582 | |
| Phone number | 812-219-1298 |
| Fax number | N/A |
| Establishment Registration # | 1818910 |
| Name of contact person | Mary Wood |
| Date prepared | May 8, 2020 |
| Name of device | |
| Trade or proprietary name | ATTUNE™ Total Knee System |
| Common or usual name | Total Knee Arthroplasty Prosthesis |
| Classification name | Knee joint patellofemorotibial polymer/metal/polymer semi-constrainedcemented prosthesis |
| Knee joint patellofemorotibial metal/polymer porous-coateduncemented prosthesis. | |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.3560 |
| 21 CFR 888.3565 | |
| Product Code(s) | OIY, JWH, MBH |
| Legally marketed device(s) to whichequivalence is claimed | Primary Predicate:DePuy ATTUNE Knee System, K101433 |
| Reference Predicates:DePuy ATTUNE PS Knee System, K111433 | |
| DePuy ATTUNE Medialized Dome and Anatomic PatellaeComponents, K103756 | |
| ATTUNE Total Knee System – Cementless CR & PS FemoralComponents, K140881 | |
| Reason for 510(k)submission | The purpose of this submission is to extend the current approved shelflife of 5 years to 8 years. |
| Device description | The subject device is a polyethylene tibial inserts and patella componentmade from AOX Polyethylene that mates with existing cemented andnoncemented femoral and tibial base components |
| Intended use of the device | The DePuy Attune Total Knee System is intended for cemented and noncemented use as a total knee replacement system. |
| 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 purpose of this submission is to propose a change in shelf life from 5 years for the ATTUNE AOX Fixed Bearing Tibial Inserts for both CR (Cruciate Retaining) and PS (Posterior Stabilized) as well as the Medialized Dome and Anatomic Patellae components
There are no other modifications associated with the currently marketed products. The intended use, product design, principle of operation and materials are not impacted by this change.
| Non-Clinical Testing: | The following testing was conducted (in compliance with FDA GuidanceClass II Special Controls Guidance Document: Knee JointPatellofemorotibial and Femorotibial Metal/Polymer Porous-CoatedUncemented Prostheses: Guidance for Industry and FDA) to demonstratesubstantial equivalence of safety and efficacy with the predicate devices:Material Oxidation Index/Resistance Testing (ASTM F2102-17 ASTM F2003) Wear Testing with Particle Analysis (ISO 14243-2, ISO 14243-3 ASTM F1877-05) |
|---|---|
| Clinical Testing: | Clinical testing was not necessary to determine substantial equivalencebetween the ATTUNE Polyethylene Fixed Bearing Tibia Inserts andPatella components and the predicate devices. |
| Conclusions drawn fromnon-clinical and clinicaldata | The subject ATTUNE Polyethylene Fixed Bearing Tibia Inserts and Patellacomponents with 8 year shelf life are substantially equivalent to thepredicate ATTUNE Polyethylene Fixed Bearing Tibia Inserts and Patellacomponents with 5 year shelf life. |
The testing provided below was used to support equivalence to the predicate devices.
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Note: There have been no modifications made to the intended use, design, biocompatibility, materials, sterilization or packaging of the existing DePuy ATTUNE Knee System.
The only modification being sought via this Special 510(k) submission is a change in the shelf life of the ATTUNE C/R Fixed Bearing Insert, ATTUNE P/S Fixed Bearing Insert and the ATTUNE Medialized Dome and Anatomic Patellae components which are made from AOX Polyethylene that is gamma irradiated.
The ATTUNE Knee System is not an invitro-diagnostic device.
Submission Purpose
The purpose of this submission is to propose a change in shelf life from 5 years to 8 years for the ATTUNE AOX Fixed Bearing Tibial Inserts for both CR (Cruciate Retaining) and PS (Posterior Stabilized) as well as the Medialized Dome and Anatomic Patellae components. A complete list of the affected devices is provided as Exhibit A. The change will require an update to the shelf life indicated on the Labeling. Draft labeling is provided as Exhibit B.
There are no other modifications associated with the currently marketed product predicate ATTUNE Total Knee System. The intended use, product design, principle of operation and materials are not impacted by this change.
Device Description
The ATTUNE CR Fixed Bearing Tibial inserts are available in sizes 1-10 and in thicknesses of 5, 6, 7, 8, 10, 12, 14, 16, and 18mm. They are manufactured from AOX ultra high molecular weight polyethylene.
The ATTUNE PS Fixed Bearing Tibial Inserts are available in sizes 1-10 and in thicknesses of 5, 6, 7, 8, 10, 12, 14, 16, 18, 20, and 22mm. They are manufactured from AOX ultra high molecular weight polyethylene.
The ATTUNE Medialized Dome and Medialized Anatomic Patellae are available in sizes 29, 32, 35, 38. and 41mm. They are manufactured from AOX ultra high molecular weight polyethylene.
The proposed change to the shelf life of the subject AOX components will have no impact to the predicate, ATTUNE Knee System (K101433, K111433, K103756, K140881) which are intended for both cemented and noncemented use.
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Materials
The subject ATTUNE Fixed Bearing Tibial Inserts and Patellae components are manufactured from AOX Polyethylene. This change proposes a shelf life change from 5 to 8 years; no material or sterilization changes are proposed.
Design
No design changes are proposed for this submission. The change is to extend the shelf life of the existing ATTUNE AOX Fixed Bearing Tibial Inserts and Patellae components from 5 years to 8 years.
§ 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.