ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology

K202194 · Depuy Ireland UC · MBH · Nov 25, 2020 · Orthopedic

Device Facts

• Record ID: K202194
• Device Name: ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology
• Applicant: Depuy Ireland UC
• Product Code: MBH · Orthopedic
• Decision Date: Nov 25, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 crippled 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

The ATTUNE Porous Fixed Bearing Tibial Base and Medialized Patellae (Dome/Anatomic) are orthopedic implants designed for total knee arthroplasty. The device utilizes AFFIXIUM 3DP technology, which involves 3D-printed titanium alloy (Ti-6Al-4V) structures on bone-apposing surfaces to facilitate biological fixation. The tibial base is a metal component; the patellar components consist of a 3D-printed titanium metal backing with an AOX ultra-high molecular weight polyethylene (UHMWPE) articulation surface. These components are integrated into the existing ATTUNE Total Knee Replacement System to replace damaged knee joint surfaces. The device is intended for use by orthopedic surgeons in a clinical/surgical setting. By providing a porous-coated surface for cementless or cemented fixation, the device aims to improve patient mobility and reduce pain associated with knee joint degeneration or failure.

Clinical Evidence

No clinical data was required or provided. Substantial equivalence was demonstrated through non-clinical bench testing, including tray and peg fatigue testing (ASTM F1800), coating characterization (ASTM F1044, F1147, F1160), abrasion, corrosion analysis (ASTM G5-14), and biocompatibility testing.

Technological Characteristics

Materials: Titanium alloy (ASTM F-136, ASTM F-3001) and AOX UHMWPE (ASTM F-648). Features: 3D-printed porous fixation geometry. Fixation: Cementless or cemented. Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for cementless use within the ATTUNE Total Knee Replacement System for patients with severely painful and/or impaired knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant, provided adequate bone is present. Porous coated implants may be used with or without cement.

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

• DePuy ATTUNE Knee System (K101433)
• DePuy ATTUNE Medialized Dome and Anatomic Patellae (K103756)
• Triathlon Tritanium Tibial Baseplate (K123486)
• Triathlon Tritanium Metal-Backed Patella (K132624)

Reference Devices

• DePuy ATTUNE Cementless CR & PS Femoral Components (K140881)
• DePuy ATTUNE Revision Knee System (K160700)
• DePuy ATTUNE Total Knee System (K201347)

Submission Summary (Full Text)

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November 25, 2020

DePuy Ireland UC % Kathy Boggs Senior Regulatory Affairs Specialist DePuy Orthopaedic, Inc. 700 Orthopaedic Drive WARSAW IN 46582

Re: K202194

Trade/Device Name: ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology 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: October 19, 2020 Received: October 20, 2020

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.

for

Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

### 510(k) Number (if known)

### K202194

#### Device Name

ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella andomic Patella with AFFIXUM™ 3DP Technology

#### Indications for Use (Describe)

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 and/or impaired knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present).

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| <span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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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<br>Co. Cork Munster, IRELAND |
| Phone number | 574-371-4945 |
| Fax number | N/A |
| Establishment Registration<br>Number | 3015516266 |
| Name of contact person | Kathy Boggs |
| Date prepared | August 03, 2020 |
| Name of device | |
| Trade or proprietary name | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella,<br>and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology |
| Common or usual name | Total Knee Prosthesis |
| Classification name | Knee joint patellofemorotibial metal/polymer porous-coated<br>uncemented prosthesis.<br>Knee joint patellofemorotibial polymer/metal/polymer semi-<br>constrained cemented prosthesis |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | Primary: 21 CFR 888.3565<br>Secondary: 21 CFR 888.3560 |
| Product Code(s) | Primary: MBH<br>Secondary: JWH |
| Legally marketed device(s) to<br>which equivalence is claimed | Primary Predicate for ATTUNE Porous Fixed Bearing Tibial Base:<br>DePuy ATTUNE Knee System, K101433<br><br>Primary Predicate for ATTUNE Porous Medialized Dome Patella &<br>Medialized Anatomic Patella:<br>DePuy ATTUNE Medialized Dome and Anatomic Patellae, K103756<br><br>Secondary Predicate for ATTUNE Porous Fixed Bearing Tibial Base:<br>Triathlon Tritanium Tibial Baseplate, K123486<br><br>Secondary Predicate for ATTUNE Porous Medialized Dome Patella &<br>Medialized Anatomic Patella:<br>Triathlon Tritanium Metal-Backed Patella, K132624<br><br>Reference Devices:<br>DePuy ATTUNE Cementless CR & PS Femoral Components, K140881 |
| | DePuy ATTUNE Revision Knee System, K160700<br>DePuy ATTUNE Total Knee System, K201347 |
| Reason for 510(k) submission | Addition of new porous fixed bearing tibial bases and patellae devices to the<br>ATTUNE Knee System. |
| Device description | The ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella<br>and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology are<br>compatible with the ATTUNE Knee System composed of individually<br>packaged femoral, tibial and patellar components designed to replace the<br>natural articular surface of the knee joint. The femoral component is a metal<br>implant with or without porous coating. The tibial component may be<br>comprised of a metal tibial base with or without porous coating, and a<br>polyethylene insert and locking components, or be an all polyethylene device.<br>The patella component may be of an all polyethylene design or a polyethylene<br>patella with porous metal backing. |
| Intended use of the device | Total knee arthroplasty is intended to provide increased patient mobility and<br>reduced pain by replacing the damaged knee joint articulation in patients where<br>there is evidence of sufficient sound bone to seat and support the components.<br>total knee replacement may be considered for younger patients if, in the opinion<br>of the surgeon, an unequivocal indication for total knee replacement outweighs<br>the risks associated with the age of the patient, and if limited demands regarding<br>activity and knee joint loading can be assured. this includes severely crippled<br>patients with multiple joint involvement for whom a gain in knee mobility may<br>lead to an expectation of significant improvement in the quality of their lives. |
| Indications for use | The ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella<br>and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are<br>intended for cementless use within the ATTUNE® Total Knee Replacement<br>System. Porous coated implants may be used with or without cement.<br>Candidates for total knee replacement include patients with a severely<br>painful and/or impaired knee function resulting from osteoarthritis, post-<br>traumatic arthritis, or a failed previous implant (provided that adequate bone<br>is present). |

# Traditional 510(k) ATTUNE AFFIXIUM

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

The DePuy ATTUNE Porous Fixed Bearing (FB) Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are similar to the predicate DePuy ATTUNE Total Knee System (K101433, K103756) and the predicate Stryker Triathlon Tritanium Tibial Baseplate and Metal-Backed Patella (K123486, K132624) in principle of operation, intended use, classification, design, materials and fixation.

The ATTUNE Porous FB Tibial Base with AFFIXIUM 3DP Technology is manufactured from Titanium alloy (Ti-6Al-4V), available in sizes 1-10, and intended for cemented use within the ATTUNE Total Knee Replacement System. The bone apposing surfaces are comprised of 3D printed fixation features with a porous and solid geometry that enable biological fixation of the bone. The proximal surface is designed to work with currently available ATTUNE FB tibial inserts.

The ATTUNE Porous Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are manufactured from 3D printed Titanium alloy (Ti-6A1-4V) substrate for the bone opposing surfaces with the articulation surface being produced from AOX ultra high polyethylene (UHMWPE). The patellae are available in sizes 32, 35, 38, and 41mm and are intended for cemented use within the ATTUNE Total Knee Replacement System. The articular surface is designed to work with currently available ATTUNE Femoral Components.

The subject devices and the predicate Stryker Triathlon Titanium Tibial Baseplate and Metal-Backed Patella (K123486, K132624) both utilize a 3D printed titanium porous structure for biological fixation, while the predicate DePuy ATTUNE Total Knee System (K101433, K103756) uses cement fixation.

| Tibial Base<br>Characteristics | Subject Device:<br>DePuy ATTUNE Porous<br>FB Tibial Base with<br>AFFIXIUM 3DP<br>Technology | Secondary Predicate Device:<br>Stryker Triathlon Tritanium<br>Tibial Baseplate<br>K123486 | Primary Predicate Device:<br>DePuy ATTUNE FB Tibial<br>Base<br>K101433 |
|--------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Material | Titanium Alloy ASTM F-<br>136<br>Titanium Alloy ASTM F-<br>3001 | Titanium Alloy ASTM F-136<br>CP Titanium ASTM F-67 | Cast Co-Cr-Mo alloy<br>ASTM F-75 |
| Fixation | Cementless or Cemented | Cementless or Cemented | Cemented |
| Sizes | Sizes 1 to 10 | Sizes 1 to 8 | Sizes 1 to 10 |

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| Patella<br>Characteristics | Subject Device:<br>DePuy ATTUNE Porous<br>Medialized Dome and<br>Medialized Anatomic<br>Patellae with AFFIXIUM<br>3DP Technology | Secondary Predicate Device:<br>Stryker Triathlon Tritanium<br>Metal-Backed Patella<br>K132624 | Primary Predicate<br>Device:<br>DePuy ATTUNE<br>Medialized Dome and<br>Anatomic Patellae<br>K103756 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Material | Metal Back:<br>Ti6Al4V Alloy<br>(ASTM F-3001)<br>Articulation Surface:<br>AOX UHMWPE<br>(ASTM F-648) | Metal Back:<br>CP Titanium powder<br>(ASTM F-1580)<br>Articulation Surface:<br>UHMWPE (ASTM F-648) | AOX UHMWPE<br>(ASTM F-648) |
| Fixation | Cementless or Cemented | Cementless or Cemented | Cemented |
| Sizes | 32, 35, 38, and 41 mm | Symmetric & Asymmetric<br>Symmetric:<br>31, 33, 36, 39 mm<br>Asymmetric:<br>S/I: 29, 32, 35, 38, 40<br>M/L: 33, 36, 39, 42, 44 | 29, 32, 35, 38, and 41 mm |

### 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) in support of the ATTUNE Porous FB Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Technology to demonstrate substantial equivalence of safety and efficacy with the predicate devices:

Tibial Base:

- Tray fatigue testing per ASTM F1800
- Peg fatigue testing ●
- Fixation testing ●
- Biocompatibility testing ●

Patella:

- . Peg fatigue testing
- . Biocompatibility testing

Coating Characterization:

- Static interfacial shear per ASTM F1044 .
- Static interfacial tensile per ASTM F1147 ●
- . Interfacial shear fatigue ASTM F1160
- Abrasion testing ●
- Corrosion analysis per ASTM G5-14 ●

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- Chemical composition analysis per ASTM E2371, ASTM E1409, ASTM E1941-10, ASTM E1447-09 .
- Morphological evaluation .
- . Biocompatibility testing

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 DePuy ATTUNE Porous FB Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are substantially equivalent to the predicate devices; DePuy ATTUNE Total Knee System, Stryker Triathlon Tritanium Tibial Baseplate and Metal-Backed Patella.