(90 days)
No
The 510(k) summary describes a physical knee implant component and its mechanical testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is a total knee replacement component, which is a therapeutic intervention for patients with knee joint conditions.
No
The device is described as an all polyethylene tibia component intended for knee replacement, which is a treatment, not a diagnostic procedure. The "Summary of Performance Studies" focuses on mechanical testing of the implant.
No
The device description clearly states it is an "all polyethylene tibia component," which is a physical implant, 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 a surgical implant for total knee replacement in patients with specific joint conditions. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is a physical component (all polyethylene tibia component) designed to be implanted in the body. 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. The performance studies focus on mechanical properties and wear, which are relevant to the function of a surgical implant.
Therefore, this device falls under the category of a surgical implant, not an In Vitro Diagnostic device.
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
JWH
Device Description
The subject device is an all polyethylene tibia component made from AOX Polyethylene that mates with existing ATTUNE cemented (K101433) and cementless (K140881) femoral components, and existing ATTUNE patella components (K103756).
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) on the ATTUNE All Polyethylene Tibia to demonstrate substantial equivalence of safety and efficacy with the predicate device:
Contact Area / Pressure (PS and CR)
Wear (PS and CR)
Constraint on tibiofemoral interface (PS and CR)
Spine Fatigue (PS)
C2 Fixation Testing (PS)
Range of Motion (PS and CR)
The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSI AAMI ST-72-2011
No clinical testing was conducted to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K943462, K950010, K961685, K971189, K101433
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
January 30, 2020
DePuy Ireland UC % Kellie Myers Senior Regulatory Affairs Specialist DePuy Synthes, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582
Re: K193057
Trade/Device Name: ATTUNE All Polyethylene Tibia Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: October 31, 2019 Received: November 1, 2019
Dear Kellie Myers:
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,
Ting Song 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
2
Indications for Use
510(k) Number (if known) K193057
Device Name
ATTUNE All Polyethylene Tibia
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 | 574-372-7276 |
| Fax number | 574- 371-4987 |
| Establishment Registration | |
| Number | 3015516266 |
| Name of contact person | Kellie Myers |
| Date prepared | 27 September 2019 |
| Name of device | |
| Trade or proprietary name | ATTUNE All Polyethylene Tibia |
| Common or usual name | Total Knee Arthoplasty 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) | JWH |
| Legally marketed device(s) to | |
| which equivalence is claimed | Darwin Knee System, K943462 |
| Darwin Knee System (Cruciate-Substituting) Porous Coated and Non- | |
| Porous Coated, K950010 | |
| P.F.C. Cruciate Retaining Knee System (Size 1.5), K961685 | |
| P.F.C. Sigma Knee System (Size 1.5), K971189 | |
| DePuy ATTUNE Knee System, K101433 | |
| Reason for 510(k) submission | This 510(k) submission is to add the ATTUNE All Polyethylene Tibia to the |
| currently cleared ATTUNE Knee System. | |
| Device description | The subject device is an all polyethylene tibia component made from AOX |
| Polyethylene that mates with existing ATTUNE cemented (K101433) and | |
| cementless (K140881) femoral components, and existing ATTUNE patella | |
| components (K103756). | |
| Intended use of the device | Cemented 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. |
4
| Characteristics | Subject Device:
DePuy Synthes
ATTUNE All Poly
Tibia | Predicate Device #1:
Darwin Knee
System
(K943462) | Predicate Device #2:
Darwin Knee System
(Cruciate-Substituting)
Porous Coated and
Non-Porous Coated
(K950010) | Predicate Device #3:
P.F.C. Cruciate
Retaining Knee System
(Size 1.5)
(K961685) | Predicate Device #4:
P.F.C. Sigma Knee
System (Size 1.5)
(K971189) | Predicate Device
#5: ATTUNE
Knee System
(K101433) |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Total knee
arthroplasty | Total knee
arthroplasty | Total knee arthroplasty | Total knee arthroplasty | Total knee
arthroplasty | Total knee
arthroplasty |
| Properties
Material | AOX UHMWPE | UHMWPE | UHMWPE | UHMWPE | UHMWPE | AOX UHMWPE |
| Fixation | Cemented | Cemented | Cemented | Cemented | Cemented | Cemented |
| Sizes | Cruciate-Retaining
(CR)
• Sizes 1-10 with
5, 6, 7, 8, 9, 10 and
12mm options for
each
Posterior-Stabilized
(PS)
• Size 1-10 with
5, 6, 7, 8, 9, 10 and
12mm options for
each | Curved (CR)
• Sizes 2, 2.5, 3, 4,
and 5 with 8mm,
10mm, 12.5 mm,
and 15mm options
for each | Stabilized (PS)
Sizes 2, 2.5, 3, 4, and 5
with 8mm, 10mm, 12.5
mm, and 15mm options
for each | Curved (CR)
Size 1.5 with 8mm,
10mm, 12.5 mm, and
15mm options | Stabilized (PS)
Size 1.5 with 8mm,
10mm, 12.5 mm,
and 15mm options | CR Fixed Bearing
Tibial Inserts
• Sizes 1-10 with
5, 6, 7, 8, 10, 12,
14, 16mm
options for each
PS Fixed Bearing
Tibial Inserts
• Sizes 1-10 with
5, 6, 7, 8, 10, 12,
14, 16 mm
options for each |
| Design Features
Cruciate
Retaining (CR)
Tibia | Posterior cut-out | Posterior cut-out | N/A | Posterior cut-out | N/A | Posterior cut-out |
| Posterior
Stabilized (PS)
Tibia | Posterior spine | N/A | Posterior spine | N/A | Posterior spine | Posterior spine |
5
| Modularity | Packaging | Sterile Method | Sterility
Assurance Level | Shelf Life | Packaging
Description | Compatible
CR Tibial
Component |
|----------------------------------------------------------|-----------|-------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Monobloc tibial
component made of
all polyethylene | | Gamma radiation
(75kGy to 90 kGy)
(50-60 kGy
crosslinking dose,
then 25-40 kGy
terminal sterilization
dose) | 10-6 | 5 years | Inner foil pouch
laminated out of
foil/LLDPE/Polyester
materials and
vacuumed, packaged
inside a Tyvek/blister
tray with a foam
protector
configuration | ATTUNE CR
Femoral Components
(porous coating (PC)
or no PC) |
| Monobloc tibial
component made of
all polyethylene | | Gamma radiation
(25kGy to 50 kGy
single dose) | 10-6 | 5 years | Inner foil pouch
laminated out of
foil/LLDPE/Polyester
materials and
vacuumed, packaged
inside a Tyvek/blister
tray with a foam
protector
configuration | P.F.C. II CR Femoral
Component (PC or
no PC) |
| Monobloc tibial
component made of
all polyethylene | | Gamma radiation
(25kGy to 50 kGy
single dose) | 10-6 | 5 years | Inner foil pouch
laminated out of
foil/LLDPE/Polyester
materials and
vacuumed, packaged
inside a Tyvek/blister
tray with a foam
protector
configuration | P.F.C. II CS Femoral
Component (PC or no
PC) |
| Monobloc tibial
component made of
all polyethylene | | Gamma radiation
(25kGy to 50 kGy
single dose) | 10-6 | 5 years | Inner foil pouch
laminated out of
foil/LLDPE/Polyester
materials and
vacuumed, packaged
inside a Tyvek/blister
tray with a foam
protector
configuration | P.F.C. II CR Femoral
Component (PC or no
PC) |
| Monobloc tibial
component made of
all polyethylene | | Gamma radiation
(25kGy to 50 kGy
single dose) | 10-6 | 5 years | Inner foil pouch
laminated out of
foil/LLDPE/Polyester
materials and
vacuumed, packaged
inside a Tyvek/blister
tray with a foam
protector
configuration | P.F.C. II CS Femoral
Component (PC or no
PC) |
| Tibial inserts snap
into modular tibial
trays | | Gamma radiation
(75kGy to 90 kGy
single dose) | 10-6 | 5 years | Inner foil pouches
and outer rigid
blister trays with
Tyvek lids | ATTUNE CR
Femoral
Component (PC or
no PC)
ATTUNE Fixed
Bearing Tibial
Baseplates |
6
| PS Tibial
Component | ATTUNE Medialized
Dome Patella;
ATTUNE Medialized
Anatomic Patella | P.F.C. II System
Oval-Dome Patella | P.F.C. II CR Femoral
Component (PC or
no PC) | P.F.C. II CS Femoral
Component (PC or no
PC) | P.F.C. II System
Oval-Dome Patella | ATTUNE
Medialized Dome
Patella; ATTUNE
Medialized
Anatomic Patella |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------|----------------------------------------------------|----------------------------------------------------|---------------------------------------|--------------------------------------------------------------------------------|
| | ATTUNE PS
Femoral Components
(PC or no PC) | P.F.C. II System Oval-
Dome Patella | P.F.C. II CR Femoral
Component (PC or
no PC) | P.F.C. II CS Femoral
Component (PC or no
PC) | P.F.C. II System
Oval-Dome Patella | ATTUNE PS
Femoral
Components (PC or
no PC) |
| | ATTUNE Medialized
Dome Patella;
ATTUNE Medialized
Anatomic Patella | P.F.C. II System Oval-
Dome Patella | P.F.C. II System Oval-
Dome Patella | P.F.C. II System
Oval-Dome Patella | P.F.C. II System
Oval-Dome Patella | ATTUNE Fixed
Bearing Tibial
Baseplates |
| | | | | | | ATTUNE
Medialized Dome
Patella; ATTUNE
Medialized
Anatomic Patella |
| 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) on the ATTUNE All Polyethylene Tibia to demonstrate
substantial equivalence of safety and efficacy with the predicate device: | | | | | | |
| Contact Area / Pressure (PS and CR)Wear (PS and CR)Constraint on tibiofemoral interface (PS and CR)Spine Fatigue (PS)C2 Fixation Testing (PS)Range of Motion (PS and CR) | | | | | | |
| The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSI AAMI ST-72-2011 | | | | | | |
7
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL | INFORMATION |
|---|---|
| No clinical testing was conducted to demonstrate substantial equivalence. | |
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | |
| The subject DePuy Synthes ATTUNE All Polyethylene Tibia is substantially equivalent to the predicate Sigma All Polyethylene Tibia cleared under |
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