(92 days)
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.
A Total Knee Prosthesis is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant with or without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base with or without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design or a polyethylene patella with porous metal backing.
The ATTUNE Medial Stabilized FB Insert is an asymmetrical fixed bearing tibial insert that will form part of the ATTUNE Knee system. It is designed to work with the ATTUNE CR femur and any of the ATTUNE Fixed Bearing Tibial Base options. The insert can be used with or without the posterior cruciate ligament.
Here's a breakdown of the requested information based on the provided text. It's important to note that this document is a 510(k) summary for a medical device (a knee implant insert), not typically a submission for an AI/ML powered device. Therefore, many of the requested AI/ML specific details (like sample size for test set, number of experts, adjudication, MRMC, standalone performance, training set details) are not applicable or not present in this type of submission.
Device Name: ATTUNE Medial Stabilized Fixed Bearing (MS FB) Insert
Device Type: Knee implant insert (part of a total knee replacement system)
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a knee implant and not an AI/ML device, the "acceptance criteria" are related to mechanical and physical performance, demonstrating substantial equivalence to a predicate device, rather than diagnostic accuracy metrics.
| Performance Characteristic | Acceptance Criteria (Implicit: Substantially Equivalent to Predicate) | Reported Device Performance |
|---|---|---|
| Contact Area & Pressure | Demonstrated substantial equivalence to predicate device (K201347) | Met requirements |
| Constraint | Demonstrated substantial equivalence to predicate device (K201347) | Met requirements |
| Tibiofemoral Range of Motion | Demonstrated substantial equivalence to predicate device (K201347) | Met requirements |
| Bacterial Endotoxin | Meet requirements of ANSI/AAMI ST 72:2019 | Met requirements |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. This is a physical medical device. The "tests" refer to non-clinical laboratory and mechanical testing of the physical implant components, not data analysis on a "test set" of patient data for an AI/ML algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth in the context of AI/ML diagnostic devices is typically established by medical experts reviewing cases. For this physical knee implant, "ground truth" relates to engineering specifications and performance standards established through mechanical and material testing, not expert interpretation of patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication is a process for resolving discrepancies among expert readers in AI/ML studies. This is a non-clinical, mechanical performance study.
5. 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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic tools that assist human readers. This submission is for a physical knee implant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical knee implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering Specifications and Performance Standards. The "ground truth" for this device's performance would be the established engineering specifications for material properties, mechanical integrity, and kinematic behavior, as well as the performance of the legally marketed predicate device to which it claims substantial equivalence. These are assessed through physical and mechanical tests.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not Applicable. (See #8)
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August 25, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
DePuy Ireland UC Brad Osborne Regulatory Specialist III Loughbeg Ringaskiddy, Co Cork Ireland
Re: K211609
Trade/Device Name: ATTUNE® Medial Stabilized (MS) Fixed Bearing (FB) Insert Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBH, OIY Dated: August 11, 2021 Received: August 12, 2021
Dear Brad Osborne:
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, Ph.D. Assistant Director DHT6A: Division of Spinal 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
K211609 Page 1 of 1
510(k) Number (if known)
Device Name
ATTUNE® Medial Stabilized Fixed Bearing (MS FB) Insert
Indications for Use (Describe)
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)
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 Ireland UC |
| Address | Loughbeg, RingaskiddyCo. Cork Munster, IRELAND |
| Phone number | 574-404-3872 |
| Fax number | 574-371-4987 |
| Establishment Registration Number | 3015516266 |
| Name of contact person | Brad Osborne |
| Date prepared | 24th May, 2021 |
| Name of device | |
| Trade or proprietary name | ATTUNE® Medial Stabilized Fixed Bearing (MS FB) Insert |
| Common or usual name | Total Knee Arthroplasty Prosthesis |
| Classification name | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated,polymer/Metal/PolymerProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer +Additive |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.3560,21 CFR 888.3565,21 CFR 888.3560 |
| Product Code(s) | JWHMBHOIY |
| Legally marketed device(s) to whichequivalence is claimed | Primary Predicate:DePuy ATTUNE Knee System CR FB Insert (K101433)Secondary Predicate:Zimmer Biomet Persona MC Insert (K150090)Reference Predicate:ATTUNE All-Polyethylene Tibia (K193057)ATTUNE Revision LPS Inserts (K191779)ATTUNE Knee System CR FB Insert (K201347) |
| Reason for 510(k) submission | This 510(k) requests clearance of the ATTUNE Medial Stabilized Fixed Bearing (MS FB) Insert for use inthe previously cleared ATTUNE Knee System. |
| Device Description | A Total Knee Prosthesis is composed of individually packaged femoral, tibial and patellar componentsdesigned to replace the natural articular surface of the knee joint. The femoral component is a metalimplant with or without a porous coating. The tibial component may be an all polyethylene component orcomprised of a metal tibial base with or without porous coating, and a polyethylene insert and lockingcomponents. The patella component may be of an all polyethylene design or a polyethylene patella withporous metal backing.The ATTUNE Medial Stabilized FB Insert is an asymmetrical fixed bearing tibial insert that will formpart of the ATTUNE Knee system. It is designed to work with the ATTUNE CR femur and any of theATTUNE Fixed Bearing Tibial Base options. The insert can be used with or without the posterior cruciateligament. |
| Intended use of the device | Total Knee Arthroplasty |
| Indications for use | Candidates for total knee replacement include patients with a severely painful and/or severely disabledjoint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previousimplant |
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| Characteristics | Subject Device:DePuy Synthes ATTUNE® Knee SystemMedial Stabilized Fixed Bearing (MS FB)Inserts | Primary Predicate Device:DePuy Synthes ATTUNE® Knee SystemCruciate Retaining (CR) Fixed BearingInsert(K201347) | Secondary PredicateDevice:Zimmer Biomet PersonaKnee SystemMedial Congruent (MC)Insert(K150090) |
|---|---|---|---|
| Intended Use | Total knee arthroplasty | Total knee arthroplasty | Total knee arthroplasty |
| Indications for Use | Candidates for total knee replacementinclude patients with a severely painfuland/or severely disabled joint resultingfrom osteoarthritis, posttraumatic arthritis,rheumatoid arthritis, or a failed previousimplant. | Candidates for total knee replacementinclude patients with a severely painfuland/or severely disabled joint resultingfrom osteoarthritis, posttraumatic arthritis,rheumatoid arthritis, or a failed previousimplant. | This device is indicated forpatients with severe kneepain and disability due to:Rheumatoid arthritis,osteoarthritis, traumaticarthritis, polyarthritisCollagen disorders, and/oravascular necrosis of thefemoral condylePost-tramatic loss of jointconfiguration, particularlywhen there ispatellofemoral erosion,dysfunction or priorpatellectomyThe salvage of previouslyfailed surgical attempts orfor a knee in whichsatisfactory stability inflexion cannot be obtainedat the time of surgery |
| Properties | |||
| Material | AOX Antioxidant UHMWPE | AOX Antioxidant UHMWPE | Vivacit-E (R) AntioxidantUHMWPE |
| Design Features | |||
| Articulating Geometry | Asymmetric | Symmetric | Asymmetric |
| Packaging Description | |||
| Components | Sterile Package | Sterile Package | Sterile Package |
| Sterility | |||
| Sterile Method | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation |
The subject ATTUNE Medial Stabilized Fixed Bearing (MS FB) Insert is identical to the primary predicate DePuy ATTUNE® Knee System [K101433] in intended use, material, and fixation and overall similar in design. The subject and predicate systems are intended for total knee arthroplasty; are components of modular tibia; are made of antioxidant UHMWPE; and are intended for use in cemented or uncemented constructs. Differences include a minor change to the geometry of the articulating surface.
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PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The following tests were performed (per FDA's Class II Special Controls Guidance Document: Knee Joint Patellofemerotibial and Femerotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA) to demonstrate substantial equivalence of safety and efficacy with the predicate device:
- Contact Area & Pressure
- Constraint
- Tibiofemoral Range of Motion
The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSI/AAMI ST 72:2019.
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
No clinical testing is required to demonstrate substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The subject DePuy ATTUNE Medial Stabilized Fixed Bearing (MS FB) Inserts are substantially equivalent to the predicate DePuy Synthes ATTUNE Knee System Cruciate Retaining (CR) Fixed Bearing Insert.
§ 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.