(59 days)
No
The device description and performance studies focus on the mechanical and material properties of a knee implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a knee implant designed to replace the natural articulating surface of the knee joint in total knee arthroplasty, which is a therapeutic intervention for various knee conditions.
No
Explanation: The device is an implant for knee replacement surgery, not a diagnostic tool. Its purpose is to replace the natural articulating surface of the knee joint.
No
The device description clearly states it is comprised of physical components (femoral, housing assembly, and tibial insert) made of metal and UHMWPE, indicating it 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 clearly describes a surgical implant designed to replace the knee joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a knee implant (femoral, housing assembly, tibial insert) made of materials like metal and UHMWPE. This aligns with a surgical implant, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is implanted in vivo (inside the body) to treat a physical condition.
N/A
Intended Use / Indications for Use
The ATTUNE Revision Hinge Knee is indicated in cases for cement use in patients who have reached skeletal maturity and for whom the surgeon has decided to resect both cruciate ligaments due to the following conditions:
- Severe instability, gross deformity and/or bone loss
- Failure of a previous knee reconstruction procedure.
- Trauma or tumor resection
- Absent or markedly insufficient collateral ligaments
Product codes
KRO
Device Description
The ATTUNE™ Revision Hinge Knee, comprised of a femoral, housing assembly, and tibial insert component, is compatible with devices of the ATTUNE Knee System and the ATTUNE Revision Knee System and is designed to replace the natural articulating surface of the knee joint in total knee arthroplasty. The femoral component is a metal/ultra-high molecular weight polyethylene (UHMWPE) implant intended for cemented use. The housing assembly component is composed of both metal and antioxidant (AOX) UHMWPE subcomponents. The tibial insert component is composed of AOX UHMWPE.
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
Skeletally mature patients
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
No clinical tests were conducted to demonstrate substantial equivalence.
Non-clinical tests performed:
- Shear Testing
- Fatigue Testing
- Wear Performance
- Stability Testing
- Contact Pressure Testing
- Biocompatibility
- MRI Safety Evaluation Testing
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
November 21, 2024
DePuy Ireland UC c/o Paige Myers Regulatory Affairs Specialist II DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582
Re: K242871
Trade/Device Name: ATTUNE™ Revision Hinge Knee Regulation Number: 21 CFR 888.3510 Regulation Name: Knee Joint Femorotibial Metal/Polymer Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KRO Dated: September 20, 2024 Received: September 23, 2024
Dear Paige 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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Peter G. Allen Digitally signed by Peter G.
-S Allen -S
Date: 2024.11.21 12:31:58
-05'00'
for: Lixin Liu
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
ATTUNE™ Revision Hinge Knee
Indications for Use (Describe)
The ATTUNE Revision Hinge Knee is indicated in cases for cement use in patients who have reached skeletal maturity and for whom the surgeon has decided to resect both cruciate ligaments due to the following conditions:
-
- Severe instability, gross deformity and/or bone loss
-
- Failure of a previous knee reconstruction procedure.
-
- Trauma or tumor resection
-
- Absent or markedly insufficient collateral ligaments
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
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 | |
| Establishment Registration | |
| Number | 3015516266 |
| Name of contact person | Paige Myers |
| E-Mail Address | pmyers1@its.jnj.com and DePuySynthesJointsRegulatoryAffairs@its.jnj.com |
| Alternate Contact Person | Michael Liao |
| Alternate Contact E-Mail | mliao7@its.jnj.com |
| Alternate Contact Phone | +1 925 8901497 |
| Date prepared | 7 October 2024 |
| Name of device | |
| Trade or proprietary name | ATTUNE™ Revision Hinge Knee |
| Common or usual name | Total Hinge Knee System |
| Classification name | 21 CFR 888.3510 - Knee joint femorotibial metal/polymer constrained |
| cemented prosthesis | |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | Class II - 21 CFR 888.3510 |
| Product Code(s) | KRO: Prosthesis, Knee, Femorotibial, Constrained, Cemented, |
| Metal/Polymer | |
| Legally marketed device(s) to | |
| which equivalence is claimed | Primary Predicate Device: |
| K896048 – S-ROM/Noiles Mark 3 | |
| Secondary Predicate Device: | |
| K091453 - DePuy LPS Universal Hinge Insert Assembly | |
| Reference Predicate Device: | |
| K160700 – ATTUNE™ Revision Knee System | |
| K983014 – Summit Acetabular System | |
| Reason for 510(k) | |
| submission | Pursuant to Section 510(k) of the Federal Food, Drug and Cosmetic Act, and |
| in accordance with the Medical Device Amendments of 1976 and Subpart E | |
| of Part 807, Title 21 of the Code of Federal Regulations and as per the FDA | |
| Guidance Format for Traditional and Abbreviated 510(k)s: Guidance for | |
| Industry and Food and Drug Administration Staff (2019), DePuy Ireland UC | |
| has compiled a Traditional 510(k) Premarket Notification to obtain market | |
| clearance for the ATTUNE Revision Hinge Knee | |
| Device description | The ATTUNE™ Revision Hinge Knee, comprised of a femoral, housing assembly, and tibial insert component, is compatible with devices of the ATTUNE Knee System and the ATTUNE Revision Knee System and is designed to replace the natural articulating surface of the knee joint in total knee arthroplasty. The femoral component is a metal/ultra-high molecular weight polyethylene (UHMWPE) implant intended for cemented use. The housing assembly component is composed of both metal and antioxidant (AOX) UHMWPE subcomponents. The tibial insert component is composed of AOX UHMWPE. |
| Intended use of the device | The ATTUNE Revision Knee Hinge is intended to provide a functional articulating knee joint in skeletally mature patients with a severely painful knee and impaired knee function and/or after a failed previous implant. |
| Indications for use | The ATTUNE Revision Hinge Knee is indicated in cases for cement use in patients who have reached skeletal maturity and for whom the surgeon has decided to resect both cruciate ligaments due to the following conditions: |
- Severe instability, gross deformity and/or bone loss
- Failure of a previous knee reconstruction procedure.
- Trauma or tumor resection
- Absent or markedly insufficient collateral ligaments |
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6
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
The ATTUNE Revision Hinge Knee is substantially equivalent to its primary predicate S-ROM/Noiles Mark 3 (K89048) and secondary predicate LPS Universal Hinge Insert (K091453). The primary and secondary predicates must be used together to form a rotating hinge knee construct formed by the components of the ATTUNE Revision Hinge Knee. In addition, the subject ATTUNE Revision Hinge Knee and a reference predicate, the ATTUNE Revision Knee System (K (60700) are very sinilar in devign features. The reference predicate device ATTUNE Revision Knee System is not a rotating hinge knee construct but, is the compatible knee system for the subject device.
| Characteristics | Subject Device:
ATTUNE Revision Hinge Knee | Primary Predicate Device:
S-ROM/Noiles Mark 3
K896048 | Secondary Predicate Device:
LPS Universal Hinge Insert
K091453 | Reference Predicate Device:
ATTUNE Revision Knee System
K160700 |
|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The ATTUNE Revision Hinge
Knee is indicated in cases for
cement use in patients who have
reached skeletal maturity and for
whom the surgeon has decided to
resect both cruciate ligaments
due to the following conditions:
- Severe instability, gross
deformity and/or bone loss - Failure of a previous knee
reconstruction procedure. - Trauma or tumor resection
- Absent or markedly
insufficient collateral
ligaments | The Noiles (Mark 3) Rotating
Hinge Knee System is indicated
for severe instability, gross
deformity and/or bone loss
resulting from: - failure of a previous
prosthesis, - trauma or tumor
resection, - absent or markedly
insufficient collateral
ligaments
The Noiles (Mark 3) Rotating
Hinge Knee System is intended for
cement use. | The DePuy LPS System is
intended for use in replacement of
the mid-shaft portion of the femur,
proximal, distal and/or total femur,
and proximal tibia, especially in
cases that require extensive
resection and replacement.
Specific diagnostic indications for
use include: - malignant tumors (e.g.,
osteosarcomas,
chondrosarcomas, giant cell
tumors, bone tumors)
requiring extensive resection
and replacement: - patient conditions of
noninflammatory
degenerative joint disease
(NIDJD), e.g. avascular
necrosis, osteoarthritis, and
inflammatory joint disease
(IJD), e.g., rheumatoid
arthritis, requiring extensive
resection and replacement; - revision cases for a failed
previous prosthesis requiring
extensive resection and
replacement; - severe trauma requiring
extensive resection and
replacement | Candidates for total knee
replacement include patients with
• A severely painful and/or
severely disabled joint
resulting from osteoarthritis,
post-traumatic arthritis, or
rheumatoid arthritis.
• Moderate valgus, varus, or
flexion deformities
• Avascular necrosis of the
femoral condyle
• A previous unsuccessful
knee replacement,
osteotomy, or other knee
procedure
ATTUNE Revision Knee System
implants are designed for use in
total knee arthroplasty for
patients with:
• Absence or loss of both
cruciate ligaments
• Moderate varus-valgus or
flexion instability that
requires a bearing surface
with increased constraint in
the clinical judgment of the
surgeon.
• Bone loss that requires
supplemental fixation in the |
| | Material | | | |
| | Cobalt Chrome alloy, AOX
UHMWPE | Cobalt Chrome alloy | UHMWPE, Cobalt Chrome alloy | Cobalt Chrome alloy, AOX
UHMWPE |
| | Fixation | | | |
| | Cemented | Cemented | N/A | Cemented, Cementless |
| | Femur Sizes | | | |
| | 3 through 8 (Lefts & Rights) | XSmall, Small, Medium (Lefts & Rights) | N/A | 1 through 10 (Lefts & Rights) |
| | Tibia Insert Sizes | | | |
| | Sizes: 3 through 8
Thicknesses (mm) 8 through 26
(increasing by 2mm) | N/A | Sizes: XSmall, Small, Medium
Thickness (mm):
12,14,16,18,21,23,26,28,31 | Sizes: 1 through 10
Thicknesses (mm): 6 through 26
(increasing by 2mm) |
| | Housing
Assembly | | | |
| | Same as Predicates | Axel and Hinge Post Assembly | Axel and Hinge Post Assembly | N/A |
| | Sterility
Assurance Level | | | |
| | 10-6 | 10-6 | 10-6 | 10-6 |
| | Sterile Method | | | |
| | Gamma Radiation | Gamma Radiation | Gamma Radiation | Gamma Radiation |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION | | | | |
| No clinical tests were conducted to demonstrate substantial equivalence. | | | | |
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8
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The following tests were performed in support of the to demonstrate substantial equivalence of safety and efficacy with the predicate devices:
- Shear Testing •
- Fatigue Testing ●
- Wear Performance ●
- Stability Testing .
- Contact Pressure Testing .
- Biocompatibility .
- MRI Safety Evaluation Testing •
The ATTUNE Revision Hinge Knee is substant to is primary predicate S-ROMNoiles Mark 3 (K80048) and secondary predicate LPS Universal Hinge Insert (K091453).