(92 days)
No
The device description and performance studies focus on the mechanical properties and design of a knee prosthesis, with no mention of AI/ML technologies or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML devices.
Yes
The device, a Total Knee Prosthesis, is designed to treat severely painful and/or disabled knee joints resulting from conditions like osteoarthritis or post-traumatic arthritis by replacing the natural articular surface of the knee joint. This direct intervention to alleviate symptoms and restore function qualifies it as a therapeutic device.
No
Explanation: The device described is a Total Knee Prosthesis, which is an implant designed to replace the natural articular surface of the knee joint. Its function is to replace or restore a body part, not to identify a disease or medical condition.
No
The device description clearly outlines physical components (femoral, tibial, and patellar implants made of metal and polyethylene) designed to replace the knee joint. This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to replace a severely painful and/or disabled knee joint due to various conditions. This is a surgical intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is a physical prosthesis (femoral, tibial, and patellar components) designed to be implanted in the knee joint. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
The device is a medical device, specifically a prosthetic implant, used for treatment rather than diagnosis.
N/A
Intended Use / Indications for Use
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.
Total Knee Arthroplasty
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, MBH, OIY
Device Description
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.
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)
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.
No clinical testing is required to demonstrate substantial equivalence.
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.
0
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
1
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, Ringaskiddy |
| Co. 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/Polymer |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, | |
| polymer/Metal/Polymer | |
| Prosthesis, 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) | JWH |
| MBH | |
| OIY | |
| Legally marketed device(s) to which | |
| equivalence 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 in |
| the previously cleared ATTUNE Knee System. | |
| Device Description | 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. | |
| 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 disabled |
| joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous | |
| implant |
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| Characteristics | Subject Device:
DePuy Synthes ATTUNE® Knee System
Medial Stabilized Fixed Bearing (MS FB)
Inserts | Primary Predicate Device:
DePuy Synthes ATTUNE® Knee System
Cruciate Retaining (CR) Fixed Bearing
Insert
(K201347) | Secondary Predicate
Device:
Zimmer Biomet Persona
Knee System
Medial Congruent (MC)
Insert
(K150090) |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Total knee arthroplasty | Total knee arthroplasty | Total knee arthroplasty |
| Indications for Use | 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. | 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. | This device is indicated for
patients with severe knee
pain and disability due to:
Rheumatoid arthritis,
osteoarthritis, traumatic
arthritis, polyarthritis
Collagen disorders, and/or
avascular necrosis of the
femoral condyle
Post-tramatic loss of joint
configuration, particularly
when there is
patellofemoral erosion,
dysfunction or prior
patellectomy
The salvage of previously
failed surgical attempts or
for a knee in which
satisfactory stability in
flexion cannot be obtained
at the time of surgery |
| Properties | | | |
| Material | AOX Antioxidant UHMWPE | AOX Antioxidant UHMWPE | Vivacit-E (R) Antioxidant
UHMWPE |
| 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.