(98 days)
Not Found
No
The summary describes a mechanical knee implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a prosthetic implant for knee joint replacement, which is considered a therapeutic intervention as it treats conditions like tumors, degenerative joint disease, and trauma by restoring function.
No
The device description clearly states it is designed to "replace the tibio-femoral articular surface of the knee joint," indicating it is a prosthetic implant for treatment, not a diagnostic tool. While the "Intended Use / Indications for Use" section lists "Specific diagnostic indications for use," these are conditions that lead to the need for the device, not the device itself performing a diagnosis.
No
The device description explicitly states it consists of physical components: an AOX™ Antioxidant Polyethylene bearing, AOX Antioxidant Polyethylene bushings, and a forged cobalt chrome molybdenum hinge post. This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing parts of the knee joint in specific clinical conditions. It is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a prosthetic implant (polyethylene bearing, bushings, hinge post). This is consistent with a surgical device, not a device used to perform tests on samples from the body.
- Lack of Diagnostic Activity: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition. The device is used after a diagnosis has been made to treat the condition.
- Performance Studies: The performance studies focus on the mechanical integrity and safety of the implant itself (fatigue, subluxation, etc.), not on the accuracy or reliability of a diagnostic test.
- Predicate Devices: The predicate devices are other knee joint prostheses, further confirming its classification as a surgical implant.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
N/A
Intended Use / Indications for Use
The ATTUNE Revision LPS Insert is intended for use in prosthetic constructs for replacement of distal femur and resurfacing of the proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include: malignant tumors (e.g., osteosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement; patient conditions of non-inflammatory degenerative joint disease (NIDJ), 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. post-infection bone loss, where the surgeon has elected to excise the bone and replacement is required.
Product codes (comma separated list FDA assigned to the subject device)
KRO
Device Description
The ATTUNE Revision LPS Inserts are designed to replace the tibio-femoral articular surface of the knee joint when used in conjunction with a femoral, tibial, patellar, and other associated prostheses as required. The ATTUNE Revision LPS Insert consists of an AOX™ Antioxidant Polyethylene bearing, AOX Antioxidant Polyethylene bushings, and a forged cobalt chrome molybdenum hinge post.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint (distal femur, proximal tibia, tibio-femoral articular surface)
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)
Functional testing was conducted in compliance with FDA Guidance, Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA, to verify that the implant performance is substantially equivalent to predicate devices for anticipated in-vivo loading with the following tests: Anterior/Posterior (A/P) Shear Fatigue Verification Test, Insert Subluxation Verification Test, Hinge Post Disassembly Test, Hinge Post Fatigue Verification Test, Hinge Post Assembly Test, Hinge Post Micromotion Test. The subject devices also meet the requirement of: Bacterial endotoxin testing as specified in ANSI AAMI ST-72:2011. Clinical testing was not necessary to determine substantial equivalence between the subject and predicate devices.
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.
K091453, K101433, K111433, K160700
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.
Not Found
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
§ 888.3510 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
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October 8, 2019
Depuy (Ireland) % Soraya Hori Sr. Regulatory Affairs Associate Depuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582
Re: K191779
Trade/Device Name: Attune Revision LPS Inserts Regulation Number: 21 CFR 888.3510 Regulation Name: Knee Joint Femorotibial Metal/Polymer Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KRO Dated: July 1, 2019 Received: July 2, 2019
Dear Soraya Hori:
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
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Indications for Use
510(k) Number (if known) K191779
Device Name ATTUNE® Revision LPSTM Inserts
Indications for Use (Describe)
The ATTUNE Revision LPS Insert is intended for use in prosthetic constructs for replacement of distal femur and resurfacing of the proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:
· malignant tumors (e.g., osteosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement;
· patient conditions of non-inflammatory degenerative joint disease (NIDJ), 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.
· post-infection bone loss, where the surgeon has elected to excise the bone and replacement is required.
| 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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3
510(k) Summary
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| Submitter Information | |
|---|---|
| Name | DePuy Orthopaedics, Inc. |
| Address | 700 Orthopaedic Drive |
| Warsaw, IN 46582 | |
| Phone number | 574-372-7491 |
| Fax number | 574- 371-4987 |
| Establishment Registration | |
| Number | 1818910 |
| Name of contact person | Soraya L. Hori |
| Date prepared | July 1, 2019 |
| Name of device | |
| Trade or proprietary name | ATTUNE® Revision LPSTM Inserts |
| Common or usual name | Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer |
| Classification name | Knee joint femorotibial metal/polymer constrained cemented prosthesis |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.3510 |
| Product Code(s) | KRO |
| Legally marketed device(s) | Primary: LPS Universal Hinge Tibial Inserts, K091453 |
| to which equivalence is | |
| claimed | Secondary: ATTUNE Knee System AOX Tibial Inserts, K101433, |
| K111433, K160700 | |
| Device description | The ATTUNE Revision LPS Inserts are designed to replace the tibio- |
| femoral articular surface of the knee joint when used in conjunction with | |
| a femoral, tibial, patellar, and other associated prostheses as required. | |
| The ATTUNE Revision LPS Insert consists of an AOX™ Antioxidant | |
| Polyethylene bearing, AOX Antioxidant Polyethylene bushings, and a | |
| forged cobalt chrome molybdenum hinge post. | |
| Intended Use and | |
| Indications for use: | The ATTUNE Revision LPS Insert is intended for use in prosthetic |
| constructs for replacement of distal and/or total femur and resurfacing of | |
| the 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 non-inflammatory 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. |
| • | post-infection bone loss, where the surgeon has elected to excise the bone and replacement is required. |
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Summary of Technologies / Substantial Equivalence Discussion:
The subject ATTUNE Revision LPS Insert has the same intended use, indications, manufacturing and sterilization methods as the previously cleared LPS Universal Hinge Tibial Inserts (K091453). The subject ATTUNE Revision LPS Insert has the same intended use, materials, biocompatibility, packaging configurations, and sterilization methods as the previously cleared ATTUNE Knee System AOX Tibial Inserts (K101433, K111433, K160700).
The testing provided below was used to support equivalence to the predicate devices.
| Non-Clinical
Testing | Functional testing was conducted in compliance with FDA Guidance, Class II Special
Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial
Metal/Polymer Porous-Coated Uncemented Prostheses: Guidance for Industry and
FDA, to verify that the implant performance is substantially equivalent to predicate
devices for anticipated in-vivo loading with the following tests:
• Anterior/Posterior (A/P) Shear Fatigue Verification Test
• Insert Subluxation Verification Test
• Hinge Post Disassembly Test
• Hinge Post Fatigue Verification Test
• Hinge Post Assembly Test
• Hinge Post Micromotion Test
The subject devices also meet the requirement of:
• Bacterial endotoxin testing as specified in ANSI AAMI ST-72:2011. |
|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical
Testing: | Clinical testing was not necessary to determine substantial equivalence between the
subject and predicate devices. |
| Conclusions
drawn from
Clinical and
Non-clinical
data: | The subject ATTUNE Revision LPS Insert is substantially equivalent to the predicate
LPS Universal Hinge Tibial Inserts and ATTUNE Knee System AOX Tibial Inserts
regarding intended use, overall indications, design features, materials, sterilization, and
manufacturing.
Clinical data and conclusions were not needed for this device. |