ATTUNE Revision Knee System
Device Facts
| Record ID | K262130 |
|---|---|
| Device Name | ATTUNE Revision Knee System |
| Applicant | Depuy Orthopaedics, Inc. |
| Product Code | JWH · Orthopedic |
| Decision Date | Sep 4, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3560 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Total knee arthroplasty is a total joint replacement surgery designed 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.
Device Story
The ATTUNE Revision Knee System is a total knee prosthesis consisting of femoral, tibial, and patellar components. It replaces damaged knee joint surfaces to restore mobility and reduce pain. The system includes modular stems, sleeves, and augments for supplemental fixation in cases of bone loss. The subject device specifically comprises AOX UHMWPE fixed-bearing tibial inserts. These components are implanted by orthopedic surgeons during total knee arthroplasty. The system provides stability through constrained bearing surfaces and supplemental fixation hardware. The current modification introduces ram extrusion for raw material consolidation and a split gamma irradiation sterilization process (crosslinking followed by terminal sterilization). These changes maintain the device's function as a load-bearing implant for joint reconstruction.
Clinical Evidence
No clinical tests were conducted. Substantial equivalence is supported by non-clinical bench testing, including wear testing (ISO 14243-2), particle characterization (ASTM F1877), endurance/deformation testing (ASTM F2777), and material property analysis (ASTM F648, F2003, F2102, F281, D638, D1505, F625).
Technological Characteristics
Materials: GUR 1020 antioxidant-stabilized (AOX) UHMWPE (ASTM F648). Components: Metal femoral/tibial bases, modular stems, sleeves, augments, and polyethylene inserts. Sterilization: Gamma irradiation (split dose: 50-60kGy and 25-40kGy). Consolidation: Ram extrusion or compression molding. Form factor: Modular total knee prosthesis. Connectivity: N/A. MR status: MR Conditional.
Indications for Use
Indicated for adults with severely painful/disabled joints due to osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis; moderate valgus, varus, or flexion deformities; avascular necrosis of the femoral condyle; or previous unsuccessful knee procedures. Specifically for patients with absence/loss of both cruciate ligaments, moderate varus-valgus or flexion instability requiring increased constraint, or bone loss requiring supplemental fixation.
Regulatory Classification
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).
Predicate Devices
- Attune Revision Knee System (K160700)
Reference Devices
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
September 4, 2026
Depuy Orthopaedics, Inc.
Christina Kaucic
Project Lead, Regulatory Affairs
700 Orthopaedic Dr.
Warsaw, Indiana 46582
Re: K262130
Trade/Device Name: ATTUNE Revision Knee System
Regulation Number: 21 CFR 888.3560
Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
Regulatory Class: Class II
Product Code: JWH, MBH
Dated: June 24, 2026
Received: June 24, 2026
Dear Christina Kaucic:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K262130 - Christina Kaucic
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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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K262130 - Christina Kaucic
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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,
LIXIN LIU -S
Lixin Liu, Ph.D
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
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | | K262130 | ? |
| --- | --- | --- | --- |
| Please provide the device trade name(s). | | | ? |
| ATTUNE Revision Knee System | | | |
| Please provide your Indications for Use below. | | | ? |
| 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 clinical judgment of the surgeon The porous-coated metaphyseal sleeves are intended for either cemented or cementless applications. ANY NON POROUS-COATED COMPONENTS ARE INTENDED FOR CEMENTED USE ONLY. | | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | |
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DePuy Synthes
THE ORTHOPAEDICS COMPANY OF Johnson & Johnson
K262130 - Traditional 510(k)
Attune Revision Knee System
### 510(k) Summary
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| Contact Details | |
| --- | --- |
| Applicant Name | DePuy Orthopaedics, Inc. |
| Applicant Address | 700 Orthopaedic Drive Warsaw, IN 46852 USA |
| Applicant & Correspondent Contact Telephone | +1 574 300 1035 |
| Applicant & Correspondent Contact | Christina Kaucic |
| Applicant & Correspondent Contact Email | ckaucic@its.jnj.com |
| Correspondent Name | DePuy Orthopaedics, Inc. |
| Correspondent Address | 700 Orthopaedic Drive, Warsaw, IN 46582 United States |
| Date prepared | June 19, 2026 |
| Name of device | |
| Trade or proprietary name | ATTUNE™ Revision Knee System |
| Common or usual name | Total Knee Replacement Prosthesis |
| Classification name | 21 CFR 888.3560 – Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis 21 CFR 888.3565 – Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | Class II - 21 CFR 888.3560, 21 CFR 888.3565 |
| Product Code(s) | **JWH:** Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer **MBH:** Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
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**DePuy Synthes**^{}[] THE ORTHOPAEDICS COMPANY OF Johnson & Johnson
K262130 - Traditional510(k)^{}[] Attune™ Revision Knee System
| **Legally marketed device(s) to which equivalence is claimed** | **Predicate:** K160700 – Attune Revision Knee System **Reference Device:** K242665 – Attune Total Knee System K241000 – Attune Revision Knee System |
| --- | --- |
| **Reason for 510(k) submission** | In accordance with Section 510(k) of 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 modify the existing raw material processing and gamma irradiation dosing method for a subset of the DePuy Knee portfolio of implants; specifically, components of the ATTUNE Revision Knee System (K160700): the Attune Revision Constrained Revision System Fixed Bearing (CRS FB) tibial inserts. Updates include the addition of ram extrusion as an alternative raw material consolidation method and splitting of the sterilization dose from a single, high dose to two doses through a combination of crosslinking and terminal sterilization. |
| **Device description** | The ATTUNE Revision Knee System is a Total Knee Prosthesis 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 without a porous coating. The tibial component consists of a metal tibial base without porous coating, and a locking polyethylene insert. Some metal components have modular stems, porous and non-porous coated sleeves and/or modular augments. The patella component is an all-polyethylene design. Total knee arthroplasty may include supplemental fixation through stems, sleeves, and/or modular augments where bone loss requires said fixation in the opinion of the surgeon. Total knee arthroplasty may also include more constrained bearing surfaces where necessary to provide stability where musculoligamentous supporting structures are insufficient. Attune Revision Stems The ATTUNE Revision Press Fit and Cemented Stems are metal devices used to provide supplemental diaphyseal and metaphyseal fixation when necessary to make up for proximal tibial and/or distal femoral bone loss for |
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DePuy Synthes
THE ORTHOPAEDICS COMPANY OF Johnson & Johnson
K262130 - Traditional510(k)
Attune™ Revision Knee System
| | the ATTUNE CRS Revision Femoral component and the ATTUNE Revision Tibial Bases. Attune Revision Offset Stem Adapter The ATTUNE Offset Adapters provide the ability to achieve the desired distal femoral or proximal tibial bone coverage in cases where the location and orientation of the intramedullary bone canal prevents the optimal bone coverage. Femoral Components The ATTUNE Revision CRS Femoral Component is a metal and polyethylene femoral knee component intended for cemented use that can be used with supplemental fixation such as modular stems, porous and non-porous coated sleeves and/or modular augments if required in the judgement of the surgeon. The femoral component may be used with the native patella or a resurfaced patella. Fixed Bearing Tibial Base (Revision) The ATTUNE Revision FB Tibial Bases is a metal tibial knee component intended for cemented use that can be used with supplemental fixation such as modular stems and/or modular augments if required in the judgement of the surgeon. Porous and non-porous coated sleeves are not compatible with the ATTUNE Revision FB Tibial Bases. Fixed Bearing Tibial Insert (Revision) The ATTUNE Revision CRS FB Tibial Insert is a polyethylene component reinforced with a metal pin. The tibial inserts are secured to the metal tibial base. Tibial Sleeves The ATTUNE Revision Tibial Sleeves are metal and UHMWPE devices used to provide supplemental metaphyseal fixation for the ATTUNE Revision Tibial Base when necessary to make up for proximal tibial bone loss. The ATTUNE Revision Tibial Sleeves are available in non-porous, partially porous, and fully porous coated options. The ATTUNE Revision Tibial Sleeves are only compatible with the ATTUNE Revision Tibial Base. The ATTUNE Revision Tibial Sleeves are not compatible with the ATTUNE Primary Tibial Base or the ATTUNE Revision Fixed Bearing Tibial Base. Femoral Sleeves The ATTUNE Revision Femoral Sleeves are metal and UHMWPE devices used to provide supplemental metaphyseal fixation for the ATTUNE CRS Femoral |
| --- | --- |
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**DePuy Synthes**^{}[] THE ORTHOPAEDICS COMPANY OF Johnson & Johnson
K262130 - Traditional510(k)^{}[] Attune™ Revision Knee System
| | Component when necessary to make up for distal femoral bone loss. The ATTUNE Revision Femoral Sleeves are available in non-porous, partially porous, and fully porous coated options. **Stems** The ATTUNE Revision Press Fit and Cemented Stems are metal devices used to provide supplemental diaphyseal and metaphyseal fixation when necessary to make up for proximal tibial and/or distal femoral bone loss for the ATTUNE CRS Revision Femoral component and the ATTUNE Revision Tibial Bases. **Augments** The ATTUNE Revision Augments are metal devices intended for cemented use and are available in posterior femoral, distal femoral and tibial options to provide supplemental fixation when necessary to make up for distal femoral and/or proximal tibial bone loss for the ATTUNE CRS Revision Femoral Component and the ATTUNE CRS Revision Tibial Bases. The subject device, the ATTUNE Revision Constrained Revision System (CRS) Fixed Bearing (FB) Tibial Inserts, articulate with the ATTUNE Revision CRS Femoral Components and are manufactured from GUR 1020 antioxidant-stabilized (AOX) Ultra-High Molecular Weight Polyethylene (UHMWPE) conforming to ASTM F648. The ATTUNE Revision CRS FB Inserts are available in ten (10) sizes and varying thickness. The ATTUNE CRS FB tibial inserts were originally cleared under K160700. The Metal components of the subject system are the same as the components of the Attune Revision Knee system cleared under K241000. |
| --- | --- |
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**DePuy Synthes**^{}[] THE ORTHOPAEDICS COMPANY OF Johnson & Johnson
K262130 - Traditional510(k)^{}[] Attune™ Revision Knee System
| **Intended use of the device** | Total knee arthroplasty is a total joint replacement surgery designed 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. |
| --- | --- |
| **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, 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 clinical judgment of the surgeon The porous-coated metaphyseal sleeves are intended for either cemented or cementless applications. ANY NON POROUS-COATED COMPONENTS ARE INTENDED FOR CEMENTED USE ONLY. |
| **Substantial equivalence** | The introduction of ram extrusion as an alternative raw material consolidation method and the splitting of the sterilization dose into two doses (crosslinking of raw material and terminal sterilization of finished good) does not impact product intended use, performance, safety, effectiveness, biocompatibility, standards compliance, or labeling set forth by the predicate device. |
| **SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE** | |
| Below is a summary of the technological characteristics of the subject device compared to the predicate device, as support by performance testing: | |
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**DePuy Synthes**^{}[] THE ORTHOPAEDICS COMPANY OF Johnson & Johnson
K262130 - Traditional510(k)^{}[] Attune™ Revision Knee System
| Characteristic | Subject Device: Attune™ Revision Knee System | Predicate: Attune Revision Knee System (K160700) | Reference Device: Attune Total Knee System (K242665) | Reference Device: Attune Revision Knee System (K241000) |
| --- | --- | --- | --- | --- |
| Material | AOX UHMWPE | Same | Same | Same |
| Sterilization Method | Gamma Irradiation | Same | Same | **Same** |
| Sterilization Dose | First dose: 50- 60kGy Second dose: 25- 40kGy | 75- 90kGy | First dose: 50- 60kGy Second dose: 25-40kGy | 75- 90kGy |
| Packaging | Polyurethane bag, polyethylene foam, inner/outer PETG trays sealed with Tyvek lids, carton, shrink wrapped. | Same | Same | Same |
| Shelf Life | 5 years | 5 years | 8 years | 5 years |
| MR Compatibility | MR Conditional | N/A | MR Conditional | MR Conditional |
| Raw Material Consolidation Method | RAM extrusion or compression molding | Compression molding | RAM extrusion or compression molding | Compression molding |
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DePuy Synthes
THE ORTHOPAEDICS COMPANY OF Johnson & Johnson
K262130 - Traditional510(k)
Attune™ Revision Knee System
# PERFORMANCE DATA
# SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The following tests and evaluations were performed to determine impact of splitting of the sterilization dose from a single, high dose to two doses through a combination of crosslinking and terminal sterilization:
- ISO 14243-2:2016: Wear of total knee-joint prostheses – Part 2: Methods of measurement
- ASTM F1877-05: Standard Practice for Characterization of Particles
- ASTM F2777-16: Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
- ASTM F648-21: Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
- ANSI AAMI ISO 11137-1:2006/(R)2015: Sterilization of health care products – Radiation – Part 1: Requirements for development validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2019)]
- ASTM E2023-11: Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities
- ASTM F2003-02 (Reapproved 2015): Standard Practice for Accelerated Aging of Ultra-High-Molecular-Weight Polyethylene after Gamma Irradiation in Air
- ASTM D1505-18: Standard Test Method for Density of Plastics by the Density-Gradient Technique
- ASTM F625-10 (Reapproved 2016): Standard Test Method for Measurement of Enthalpy of Fusion Percent Crystallinity and Melting Point of Ultra-High-Molecular-Weight Polyethylene by Means of Differential Scanning Calorimetry
- ASTM F2102-17: Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
- ASTM F281-19: Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
- ASTM D638-14 Standard Test Method for Tensile Properties of Plastics
# SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
No clinical tests were conducted to demonstrate substantial equivalence.
# CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
Based on the intended use, indications for use, and technological characteristics supported by performance testing, it can be concluded that the subject Attune™ Revision Knee System is substantially equivalent to the predicate Attune™ Revision Knee System (K160700).
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