ATTUNE Total Knee System; ATTUNE Cementless Knee System

K261458 · DePuy Ireland UC · JWH · Jun 25, 2026 · Orthopedic

Device Facts

• Record ID: K261458
• Device Name: ATTUNE Total Knee System; ATTUNE Cementless Knee System
• Applicant: DePuy Ireland UC
• Product Code: JWH · Orthopedic
• Decision Date: Jun 25, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 disabled 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.

Device Story

Total knee replacement prosthesis consisting of femoral, tibial, and patellar components; replaces natural articular surface of knee joint. Subject of 510(k) is updated surgical technique and new accessory cases/trays for existing ATTUNE implants. No changes to implant design, manufacturing, or principle of operation. Used by orthopedic surgeons in clinical settings to restore mobility and reduce pain in patients with severe joint degeneration. Output is the physical implantation of the prosthesis to facilitate joint articulation. Benefits include improved patient mobility and quality of life.

Clinical Evidence

No clinical tests were conducted to demonstrate substantial equivalence. Evidence is limited to non-clinical bench testing, including simulated wear performance, computational wear analysis, cementless fixation strength, and bacterial endotoxin testing per ANSI/AAMI ST 72:2019.

Technological Characteristics

Total knee prosthesis comprising metal femoral components, metal/polyethylene tibial components, and polyethylene patellar components. Features AFFIXIUM 3DP technology for porous-coated implants. No changes to materials or energy sources. Sterilization and biocompatibility maintained per existing standards.

Indications for Use

Indicated for adults with severely painful and/or disabled joints resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implants. Cementless components require adequate bone for seating and support.

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

• K111433 - DePuy Attune Knee System
• K170806 - ATTUNE Cemented Tibial Base, Fixed Bearing
• K140881 - ATTUNE Knee System- Cementless CR and PS Femoral Components
• K202194 - ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Technology

Reference Devices

• K233980 - Bundled Knee MRI - ATTUNE, LPS, Sigma HP Uni
• K232303 - ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology

Submission Summary (Full Text)

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June 25, 2026

DePuy Ireland UC
% Paige Myers
Senior Regulatory Affairs Specialist
Depuy Orthopaedics, Inc.
700 Orthopaedic Dr.
Warsaw, Indiana 46582

Re: K261458

Trade/Device Name: ATTUNE Total Knee System; ATTUNE Cementless 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 Codes: JWH, MBH, OIY

Dated: May 1, 2026

Received: May 1, 2026

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K261458 - Paige Myers

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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

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K261458 - Paige Myers

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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-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Peter G.

Allen -S

Digitally signed by Peter

G. Allen -S

Date: 2026.06.25 17:15:21

-04'00'

for Lixin Liu, PhD

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. | | K261458 | ? |
| --- | --- | --- | --- |
| Please provide the device trade name(s). | | | ? |
| ATTUNE Total Knee System ; ATTUNE Cementless Knee System | | | |
| Please provide your Indications for Use below. | | | ? |
| ATTUNE™ Total Knee System 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. | | | |
| ATTUNE™ Cementless Knee System Indications for Use The ATTUNE™ Cementless CR and PS Femoral Components are intended for cementless use within the ATTUNE™ Total Knee Replacement System. Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present). | | | |
| 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). | | | |
| 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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K261458 page 1 of 6


Bundled Traditional 510(k)
ATTUNE™ Total Knee System,
ATTUNE™ Cementless Knee System

# **510(K) SUMMARY**

(As required by 21 CFR 807.92 and 21 CFR 807.93)

| **Contact Information** | |
| --- | --- |
| **Applicant Name** | DePuy Ireland UC |
| **Applicant Address** | Loughbeg, Ringaskiddy Co. Cork Munster, IRELAND |
| **Applicant Establishment Registration Number** | 3015516266 |
| **Applicant Contact Telephone** | [phone] |
| **Applicant Contact Email** | [e-mail] |
| **Applicant Contact** | Paige Myers |
| **Correspondent Name** | DePuy Orthopaedics, Inc. |
| **Correspondent Address** | 700 Orthopaedic Drive, Warsaw, IN 46582 USA |
| **Alt. Contact Telephone** | [phone] |
| **Alternate Contact Email** | [e-mail] |
| **Alternate Contact Name** | Michael Liao |
| **Date prepared** | 1 May 2026 |
| **Name of device** | |
| **Trade or proprietary name** | ATTUNE™ Total 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 |
| **Class** | II |
| **Classification panel** | 87 Orthopedics |
| **Regulation** | Class II - 21 CFR 888.3560 |
| **Product Code(s)** | **JWH:** Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer **OIY:** Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive |
| **Legally marketed device(s) to which equivalence is claimed** | Primary Predicate: **K111433** - DePuy Attune™ Knee System Secondary Predicate: **K170806** – ATTUNE Cemented Tibial Base, Fixed Bearing |

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K261458 page 2 of 6


**Bundled Traditional 510(k)**
**ATTUNE™ Total Knee System,**
**ATTUNE™ Cementless Knee System**

| | Reference Device: **K233980** – Bundled Knee MRI - ATTUNE, LPS, Sigma HP Uni |
| --- | --- |
| **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, Bundling Multiple Devices or Multiple Indications in a Single Submission: Guidance for Industry and FDA Staff (June 2007), DePuy Ireland UC has compiled a Bundled Traditional 510(k) Premarket Notification to modify labeling to include an updated surgical technique for DePuy ATTUNE™ Total Knee System (K111433, K170806). Additionally, cases and trays that are associated with this new surgical technique are being introduced as accessories to the existing implant devices. |
| **Device description** | A Total Knee Prosthesis is 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 may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design. |
| **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 disabled 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** | 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. |
| **Substantial Equivalence** | There are no changes in design, manufacturing, principle of operation, indication, or intended use. The only change is the creation of an additional surgical technique for the existing implants and the addition of new case and trays that are now to be considered as device accessories. |

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K261458 page 3 of 6


Bundled Traditional 510(k)
ATTUNE™ Total Knee System,
ATTUNE™ Cementless Knee System

# SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

# PERFORMANCE DATA

# SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The following tests were performed to address:

- Simulated Wear Performance
- Computation Wear Analysis

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

No clinical tests were conducted to demonstrate substantial equivalence.

# CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The subject device, DePuy ATTUNE Total Knee System, is substantially equivalent to the predicate ATTUNE Total Knee System (K11433, K170806).

# Contact Information

| **Applicant Name** | DePuy Ireland UC |
| --- | --- |
| **Applicant Address** | Loughbeg, Ringaskiddy Co. Cork Munster, IRELAND |
| **Applicant Establishment Registration Number** | 3015516266 |
| **Applicant Contact Telephone** | [phone] |
| **Applicant Contact Email** | [e-mail] |
| **Applicant Contact** | Paige Myers |
| **Correspondent Name** | DePuy Orthopaedics, Inc. |
| **Correspondent Address** | 700 Orthopaedic Drive, Warsaw, IN 46582 USA |
| **Alt. Contact Telephone** | [phone] |
| **Alternate Contact Email** | [e-mail] |
| **Alternate Contact Name** | Michael Liao |
| **Date prepared** | 1 May 2026 |

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K261458 page 4 of 6


**Bundled Traditional 510(k)**^{}[] ATTUNE™ Total Knee System,^{}[] ^{}[] ATTUNE™ Cementless Knee System

| Name of device | |
| --- | --- |
| **Trade or proprietary name** | ATTUNE™ Cementless Knee System |
| **Common or usual name** | Total Knee Prosthesis |
| **Classification name** | 21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis |
| **Class** | II |
| **Classification panel** | 87 Orthopedics |
| **Regulation** | Class II - 21 CFR 888.3565 |
| **Product Code(s)** | **MBH:** Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer **JWH:** Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| **Legally marketed device(s) to which equivalence is claimed** | Primary Predicate: **K140881** - ATTUNE™ Knee System- Cementless CR and PS Femoral Components Secondary Predicate: **K202194** – ATTUNE™ Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology Reference Devices: **K233980** – Bundled Knee MRI - ATTUNE, LPS, Sigma HP Uni, **K232303** - ATTUNE™ Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology |
| **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, Bundling Multiple Devices or Multiple Indications in a Single Submission: Guidance for Industry and FDA Staff (June 2007), DePuy Ireland UC has compiled a Bundled Traditional 510(k) Premarket Notification to modify labeling to include an updated surgical technique for DePuy, ATTUNETM Cementless Knee System (K140881). Additionally, cases and trays that are associated with this new surgical technique are being introduced as accessories to the existing implant devices |
| **Device description** | A Total Knee Prosthesis is 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 a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design. |

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K261458 page 5 of 6


**Bundled Traditional 510(k)**
**ATTUNE™ Total Knee System,**
**ATTUNE™ Cementless Knee System**

| **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 disabled 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™ Cementless CR and PS Femoral Components are intended for cementless use within the ATTUNE™ Total Knee Replacement System. Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present). 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). |
| **Substantial Equivalence** | There are no changes in design, manufacturing, principle of operation, indication, or intended use. The only change is the creation of an additional surgical technique for the existing implants and the addition of new case and trays that are now to be considered as device accessories. |

| **SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE** |
| --- |
| **PERFORMANCE DATA** |
| **SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE** |
| The following tests were performed: - Computational Wear Analysis - Cemented Fixation Strength |

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K261458 page 6 of 6

DePuy Synthes

Bundled Traditional 510(k)

ATTUNE™ Total Knee System,

ATTUNE™ Cementless Knee System

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

No clinical tests were conducted to demonstrate substantial equivalence.

# CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The subject DePuy ATTUNE Cementless Knee System is substantially equivalent to the predicate ATTUNE Knee System – Cementless (K140881) and the ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology (K202194).