ATTUNE Revision Cones

K212746 · Depuy Ireland UC · MBH · Oct 17, 2022 · Orthopedic

Device Facts

• Record ID: K212746
• Device Name: ATTUNE Revision Cones
• Applicant: Depuy Ireland UC
• Product Code: MBH · Orthopedic
• Decision Date: Oct 17, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ATTUNE Revision Cones are intended for use with the DePuy Revision Knee Systems in a revision total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, posttraumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. The ATTUNE Revision cone is to be fixated into ether the proximal tibia or distal femur with or without bone cement. After implantation of the cone, the mating compatible tibial or femoral component is affixed into the using bone cement. THE POROUS TITANIUM ATTUNE REVISION CONES ARE INTENDED FOR CEMENTED OR CEMENTLESS USE.

Device Story

ATTUNE Revision Cones provide supplemental metaphyseal fixation for proximal tibia or distal femur bone loss during revision total knee replacement. Cones are implanted into bone with or without cement; compatible tibial or femoral components are then affixed into the cone using bone cement. Available in femoral, concentric, tibial bi-lobe, and tibial tri-lobe configurations. Used in surgical settings by orthopedic surgeons. Benefits include improved stability and fixation in revision arthroplasty cases with significant bone loss.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical bench testing, including cone tibial fatigue testing (ASTM F1800), cement pull-off testing, biocompatibility, particulate analysis, MRI safety evaluation, and bacterial endotoxin testing (ANSI/AAMI ST 72:2019).

Technological Characteristics

Manufactured from Titanium Alloy (ASTM F-3001). Features 3D-printed porous structure for biological fixation. Available in multiple shapes (femoral, concentric, bi-lobe, tri-lobe) and sizes. Designed for cemented or cementless use. MRI compatible under specific conditions.

Indications for Use

Indicated for patients requiring revision total knee replacement due to severe pain and disability from permanent structural damage caused by rheumatoid arthritis, osteoarthritis, posttraumatic arthritis, collagen disorders, pseudogout, trauma, or failed prior surgical intervention.

Regulatory Classification

Identification

A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.

Predicate Devices

• Stryker Triathlon Tritanium Cone Augments (K143393)
• DePuy Universal Gription TF Cones & Acetabular Augment System (K100391)

Reference Devices

• DePuy ATTUNE Revision Knee System (K160700)
• DePuy ATTUNE Porous FB Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Technology (K202194)

Submission Summary (Full Text)

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October 17, 2022

Depuy Ireland UC % Kathy Boggs Senior Regulatory Affairs Specialist DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582

Re: K212746

Trade/Device Name: ATTUNE Revision Cones Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: August 27, 2021 Received: August 30, 2021

Dear Kathy Boggs:

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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Ting Song, 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

510(k) Number (if known) K212746

Device Name ATTUNE® Revision Cones

#### Indications for Use (Describe)

The ATTUNE Revision Cones are intended for use with the DePuy Revision Knee Systems in a revision total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, posttraumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention.

The ATTUNE Revision cone is to be fixated into ether the proximal tibia or distal femur with or without bone cement. After implantation of the cone, the mating compatible tibial or femoral component is affixed into the using bone cement.

THE POROUS TITANIUM ATTUNE REVISION CONES ARE INTENDED FOR CEMENTED OR CEMENTLESS USE.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span style="font-size:20px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span style="font-size:20px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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# 510(K) SUMMARY

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

| Submitter Information | |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | DePuy Ireland UC |
| Address | Loughbeg, Ringaskiddy |
| | Co. Cork Munster, IRELAND |
| Phone number | 574-404-8711 |
| Fax number | N/A |
| Establishment Registration<br>Number | 3015516266 |
| Name of contact person | Kathy Boggs |
| Date prepared | October 14, 2022 |
| Name of device | |
| Trade or proprietary name | ATTUNE® Revision Cones |
| Common or usual name | Total Knee Prosthesis |
| Classification name | Knee joint patellofemorotibial metal/polymer porous-coated uncemented<br>prosthesis.<br>Knee joint patellofemorotibial polymer/metal/polymer semi-constrained<br>cemented prosthesis. |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.3565<br>21 CFR 888.3560 |
| Product Code(s) | MBH<br>JWH |
| Legally marketed device(s) to<br>which equivalence is claimed | Primary Predicate:<br>Stryker Triathlon® Tritanium® Cone Augments (K143393)<br>Secondary Predicate:<br>DePuy Universal Gription™ TF Cones & Acetabular Augment System<br>(K100391)<br>Reference Devices:<br>DePuy ATTUNE Revision Knee System (K160700)<br>DePuy ATTUNE Porous FB Tibial Base, Medialized Dome Patella, and<br>Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology<br>(K202194) |
| Reason for 510(k) submission | Addition of new revision cone devices to the ATTUNE Knee System. |
| Device description | The ATTUNE® Revision Cones provide supplemental metaphyseal fixation<br>when necessary to make up for either the proximal tibia or distal femur bone<br>loss. The ATTUNE Revision Cones are available in a variety of sizes of<br>Femoral, Concentric, Tibial Bi-Lobe, and Tibial Tri-Lobe configurations.<br>They are compatible with select, commercially available DePuy Orthopaedics<br>tibial base plates and stemmed femoral components. |
| Intended use of the device | Total Knee Arthroplasty |
| Indications for use | The ATTUNE Revision Cones are intended for use with the DePuy<br>Revision Knee Systems in a revision total knee replacement surgery for<br>patients suffering from severe pain and disability due to permanent<br>structural damage resulting from rheumatoid arthritis, osteoarthritis,<br>posttraumatic arthritis, collagen disorders, pseudogout, trauma or failed<br>prior surgical intervention.<br><br>The ATTUNE Revision cone is to be fixated into either the proximal tibia<br>or distal femur with or without bone cement. After implantation of the cone,<br>the mating compatible tibial or femoral component is affixed into the<br>revision cone using bone cement.<br><br>THE POROUS TITANIUM ATTUNE REVISION CONES ARE<br>INTENDED FOR CEMENTED OR CEMENTLESS USE. |

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

The DePuy ATTUNE Revision Cones are similar to the predicate Stryker Triathlon Tritanium Cone Augments (K143393) and secondary predicate DePuy Universal Gription TF (Titanium Foam) Cones & Acetabular Augment System (K100391) in principle of operation, intended use, classification, design, material, and fixation.

The ATTUNE Revision Cones are manufactured from Titanium alloy (Ti-6Al-4V), whereas the predicates are manufactured from Commercially Pure Titanium, a difference of which is negligible. The subject device is available in four differently shaped configurations and 4-5 sizes, as identified on labeling. The Stryker predicate is available in three shapes of five sizes each, and the Gription TF predicate in two shapes of four sizes each. The ATTUNE Revision Cones are intended for cementless or cemented use, as are both predicates.

The subject devices and the predicate Stryker Triathlon Tritanium Cone Augments (K143393) both utilize a 3D printed titanium porous structure for biological fixation, while the predicate DePuy Universal Gription TF Cones & Acetabular Augment System (K100391) uses Gription Titanium Foam (TF).

| Characteristics | Subject Device:<br>DePuy ATTUNE<br>Revision Cones | Primary Predicate Device:<br>Stryker Triathlon Tritanium<br>Cone Augments<br>K143393 | Secondary Predicate<br>Device:<br>DePuy Universal<br>Gription™ TF Cones &<br>Acetabular Augment<br>System<br>K100391 |
|-----------------|---------------------------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| FDA ProCode | MBH, JWH | MBH, JWH | JWH, KRO |
| Intended Use | Total Knee Arthroplasty | Total Knee Arthroplasty | Total Knee Arthroplasty |
| Material | Titanium Alloy<br>ASTM F-3001 | CP Titanium<br>ASTM F-1580, ASTM F-67 | CP Titanium<br>ASTM F-1580 |
| Fixation | Cementless or Cemented | Cementless or Cemented | Cementless or Cemented |
| Shapes | Symmetric, asymmetric,<br>femoral | Symmetric, asymmetric,<br>femoral | Symmetric, femoral |

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#### PERFORMANCE DATA

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

The following tests were performed (per FDA's Class II Special Controls Guidance Document: Knee Joint Patellofemerotibial and Femerotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA) to demonstrate substantial equivalence of safety and efficacy with the predicate devices:

Revision Cones:

- . Cone tibial fatigue testing per ASTM F1800
- Cone tibial and femoral cement pulloff test ●
- Biocompatibility testing ●
- Particulate Analysis

Magnetic Resonance Imaging safety evaluation testing was performed, and the tests evaluated the worst-case components and constructs for magnetically induced force, torque, image artefact and RF heating. The testing concluded that there are no safety issues related to magnetic field interactions under specific conditions identified in the labeling.

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

Clinical testing was not required to demonstrate substantial equivalence.

#### CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The subject DePuy ATTUNE Revision Cones are substantially equivalent to the predicate devices; Stryker Triathlon Tritanium Cone Augments and DePuy Universal Gription™ TF Cones & Acetabular Augment System.