(112 days)
No
The summary describes a knee replacement system with porous coating technology (AFFIXIUM 3DP) and provides performance data based on mechanical and biocompatibility testing. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is a knee replacement system intended to restore impaired knee function resulting from conditions like osteoarthritis and post-traumatic arthritis.
No
Explanation: The device is a component of a total knee replacement system, which is a prosthetic implant used to replace damaged knee joints. It is designed for treatment (replacement of a joint), not for diagnosing a condition or disease.
No
The device description clearly states it is comprised of metal and polyethylene components, which are hardware. The performance studies also focus on mechanical and material properties of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for total knee replacement surgery, which is a surgical procedure performed on a patient's body. IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health.
- Device Description: The device is described as implants (femoral, tibial, and patellar components) designed to replace the natural articular surface of the knee joint. This is a physical implant, not a diagnostic tool.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose, monitor, or screen for any condition. Its purpose is to restore function to a damaged knee joint.
- Performance Studies: The performance studies focus on the mechanical properties, fixation, and biocompatibility of the implants, which are relevant to surgical implants, not diagnostic tests.
In summary, the ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are surgical implants used in total knee replacement, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are intended for cementless use within the ATTUNE® Total Knee Replacement System. Porous coated implants may be used with or without cement.
Candidates for total knee replacement include patients with a severely painful and/or impaired knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present).
Product codes (comma separated list FDA assigned to the subject device)
MBH, JWH
Device Description
The ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology are compatible with the ATTUNE Knee System 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 porous coating. The tibial component may be comprised of a metal tibial base with or without porous coating, and a polyethylene insert and locking components, or be an all polyethylene device. The patella component may be of an all polyethylene design or a polyethylene patella with porous metal backing.
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) in support of the ATTUNE Porous FB Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Technology to demonstrate substantial equivalence of safety and efficacy with the predicate devices:
Tibial Base:
- Tray fatigue testing per ASTM F1800
- Peg fatigue testing
- Fixation testing
- Biocompatibility testing
Patella:
- Peg fatigue testing
- Biocompatibility testing
Coating Characterization:
- Static interfacial shear per ASTM F1044
- Static interfacial tensile per ASTM F1147
- Interfacial shear fatigue ASTM F1160
- Abrasion testing
- Corrosion analysis per ASTM G5-14
- Chemical composition analysis per ASTM E2371, ASTM E1409, ASTM E1941-10, ASTM E1447-09
- Morphological evaluation
- Biocompatibility testing
The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSI/AAMI ST 72:2019.
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.
K101433, K103756, K123486, K132624
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
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
0
Image /page/0/Picture/0 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 the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
November 25, 2020
DePuy Ireland UC % Kathy Boggs Senior Regulatory Affairs Specialist DePuy Orthopaedic, Inc. 700 Orthopaedic Drive WARSAW IN 46582
Re: K202194
Trade/Device Name: ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: October 19, 2020 Received: October 20, 2020
Dear Kathy Boggs:
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.
1
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 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 (QS) 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 medical devices and radiation-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.
for
Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K202194
Device Name
ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella andomic Patella with AFFIXUM™ 3DP Technology
Indications for Use (Describe)
The ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are intended for cementless use within the ATTUNE® Total Knee Replacement System. Porous coated implants may be used with or without cement.
Candidates for total knee replacement include patients with and/or impaired knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present).
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 | 574-371-4945 |
| Fax number | N/A |
| Establishment Registration | |
| Number | 3015516266 |
| Name of contact person | Kathy Boggs |
| Date prepared | August 03, 2020 |
| Name of device | |
| Trade or proprietary name | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, |
| and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology | |
| Common or usual name | Total Knee Prosthesis |
| Classification name | Knee joint patellofemorotibial metal/polymer porous-coated |
| uncemented prosthesis. | |
| Knee joint patellofemorotibial polymer/metal/polymer semi- | |
| constrained cemented prosthesis | |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | Primary: 21 CFR 888.3565 |
| Secondary: 21 CFR 888.3560 | |
| Product Code(s) | Primary: MBH |
| Secondary: JWH | |
| Legally marketed device(s) to | |
| which equivalence is claimed | Primary Predicate for ATTUNE Porous Fixed Bearing Tibial Base: |
| DePuy ATTUNE Knee System, K101433 |
Primary Predicate for ATTUNE Porous Medialized Dome Patella &
Medialized Anatomic Patella:
DePuy ATTUNE Medialized Dome and Anatomic Patellae, K103756
Secondary Predicate for ATTUNE Porous Fixed Bearing Tibial Base:
Triathlon Tritanium Tibial Baseplate, K123486
Secondary Predicate for ATTUNE Porous Medialized Dome Patella &
Medialized Anatomic Patella:
Triathlon Tritanium Metal-Backed Patella, K132624
Reference Devices:
DePuy ATTUNE Cementless CR & PS Femoral Components, K140881 |
| | DePuy ATTUNE Revision Knee System, K160700
DePuy ATTUNE Total Knee System, K201347 |
| Reason for 510(k) submission | Addition of new porous fixed bearing tibial bases and patellae devices to the
ATTUNE Knee System. |
| Device description | The ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella
and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology are
compatible with the ATTUNE Knee System 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 porous coating. The tibial component may be
comprised of a metal tibial base with or without porous coating, and a
polyethylene insert and locking components, or be an all polyethylene device.
The patella component may be of an all polyethylene design or a polyethylene
patella with porous metal backing. |
| 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 | The ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella
and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are
intended for cementless use within the ATTUNE® Total Knee Replacement
System. Porous coated implants may be used with or without cement.
Candidates for total knee replacement include patients with a severely
painful and/or impaired knee function resulting from osteoarthritis, post-
traumatic arthritis, or a failed previous implant (provided that adequate bone
is present). |
Traditional 510(k) ATTUNE AFFIXIUM
4
5
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
The DePuy ATTUNE Porous Fixed Bearing (FB) Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are similar to the predicate DePuy ATTUNE Total Knee System (K101433, K103756) and the predicate Stryker Triathlon Tritanium Tibial Baseplate and Metal-Backed Patella (K123486, K132624) in principle of operation, intended use, classification, design, materials and fixation.
The ATTUNE Porous FB Tibial Base with AFFIXIUM 3DP Technology is manufactured from Titanium alloy (Ti-6Al-4V), available in sizes 1-10, and intended for cemented use within the ATTUNE Total Knee Replacement System. The bone apposing surfaces are comprised of 3D printed fixation features with a porous and solid geometry that enable biological fixation of the bone. The proximal surface is designed to work with currently available ATTUNE FB tibial inserts.
The ATTUNE Porous Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are manufactured from 3D printed Titanium alloy (Ti-6A1-4V) substrate for the bone opposing surfaces with the articulation surface being produced from AOX ultra high polyethylene (UHMWPE). The patellae are available in sizes 32, 35, 38, and 41mm and are intended for cemented use within the ATTUNE Total Knee Replacement System. The articular surface is designed to work with currently available ATTUNE Femoral Components.
The subject devices and the predicate Stryker Triathlon Titanium Tibial Baseplate and Metal-Backed Patella (K123486, K132624) both utilize a 3D printed titanium porous structure for biological fixation, while the predicate DePuy ATTUNE Total Knee System (K101433, K103756) uses cement fixation.
| Tibial Base
Characteristics | Subject Device:
DePuy ATTUNE Porous
FB Tibial Base with
AFFIXIUM 3DP
Technology | Secondary Predicate Device:
Stryker Triathlon Tritanium
Tibial Baseplate
K123486 | Primary Predicate Device:
DePuy ATTUNE FB Tibial
Base
K101433 |
|--------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Material | Titanium Alloy ASTM F-
136
Titanium Alloy ASTM F-
3001 | Titanium Alloy ASTM F-136
CP Titanium ASTM F-67 | Cast Co-Cr-Mo alloy
ASTM F-75 |
| Fixation | Cementless or Cemented | Cementless or Cemented | Cemented |
| Sizes | Sizes 1 to 10 | Sizes 1 to 8 | Sizes 1 to 10 |
6
| Patella
Characteristics | Subject Device:
DePuy ATTUNE Porous
Medialized Dome and
Medialized Anatomic
Patellae with AFFIXIUM
3DP Technology | Secondary Predicate Device:
Stryker Triathlon Tritanium
Metal-Backed Patella
K132624 | Primary Predicate
Device:
DePuy ATTUNE
Medialized Dome and
Anatomic Patellae
K103756 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Material | Metal Back:
Ti6Al4V Alloy
(ASTM F-3001)
Articulation Surface:
AOX UHMWPE
(ASTM F-648) | Metal Back:
CP Titanium powder
(ASTM F-1580)
Articulation Surface:
UHMWPE (ASTM F-648) | AOX UHMWPE
(ASTM F-648) |
| Fixation | Cementless or Cemented | Cementless or Cemented | Cemented |
| Sizes | 32, 35, 38, and 41 mm | Symmetric & Asymmetric
Symmetric:
31, 33, 36, 39 mm
Asymmetric:
S/I: 29, 32, 35, 38, 40
M/L: 33, 36, 39, 42, 44 | 29, 32, 35, 38, and 41 mm |
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) in support of the ATTUNE Porous FB Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Technology to demonstrate substantial equivalence of safety and efficacy with the predicate devices:
Tibial Base:
- Tray fatigue testing per ASTM F1800
- Peg fatigue testing ●
- Fixation testing ●
- Biocompatibility testing ●
Patella:
- . Peg fatigue testing
- . Biocompatibility testing
Coating Characterization:
- Static interfacial shear per ASTM F1044 .
- Static interfacial tensile per ASTM F1147 ●
- . Interfacial shear fatigue ASTM F1160
- Abrasion testing ●
- Corrosion analysis per ASTM G5-14 ●
7
- Chemical composition analysis per ASTM E2371, ASTM E1409, ASTM E1941-10, ASTM E1447-09 .
- Morphological evaluation .
- . Biocompatibility testing
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
Clinical testing was not required to demonstrate substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The DePuy ATTUNE Porous FB Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are substantially equivalent to the predicate devices; DePuy ATTUNE Total Knee System, Stryker Triathlon Tritanium Tibial Baseplate and Metal-Backed Patella.