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).

Device Description

The ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology are compatible with the ATTUNE Knee System 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 porous coating. The tibial component may be comprised of a metal tibial base with or without porous coating, and a polyethylene insert and locking components, or be an all polyethylene device. The patella component may be of an all polyethylene design or a polyethylene patella with porous metal backing.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology) and does not describe acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This means showing that the new device is as safe and effective as a legally marketed device that does not require premarket approval. The "acceptance criteria" in this context are related to meeting established performance standards for orthopaedic implants and demonstrating similar characteristics to the predicate devices.

Here's a breakdown of what is provided, framed as closely as possible to your request for acceptance criteria and study information, considering that the primary goal here is substantial equivalence, not a standalone performance study with accuracy metrics.

1. A table of acceptance criteria and the reported device performance

The document does not present a table of acceptance criteria in the format typically used for AI/diagnostic device performance (e.g., sensitivity >X%, specificity >Y%). Instead, the "acceptance criteria" are implied by the performance standards for orthopaedic implants to demonstrate substantial equivalence, and "reported device performance" refers to the successful completion of these tests.

Type of Test/Characteristic	Implied Acceptance Criteria (Demonstrated Substantial Equivalence)	Reported Device "Performance" (Satisfied)
Tibial Base
Tray fatigue testing (ASTM F1800)	Meet standard fatigue requirements for knee implants.	Testing performed; results support substantial equivalence.
Peg fatigue testing	Meet standard fatigue requirements for peg fixation.	Testing performed; results support substantial equivalence.
Fixation testing	Demonstrate adequate fixation strength.	Testing performed; results support substantial equivalence.
Biocompatibility testing	Be biocompatible (non-toxic, non-irritating, etc.).	Testing performed; results support substantial equivalence.
Patella
Peg fatigue testing	Meet standard fatigue requirements for peg fixation.	Testing performed; results support substantial equivalence.
Biocompatibility testing	Be biocompatible (non-toxic, non-irritating, etc.).	Testing performed; results support substantial equivalence.
Coating Characterization
Static interfacial shear (ASTM F1044)	Meet standard static shear resistance.	Testing performed; results support substantial equivalence.
Static interfacial tensile (ASTM F1147)	Meet standard static tensile resistance.	Testing performed; results support substantial equivalence.
Interfacial shear fatigue (ASTM F1160)	Meet standard fatigue resistance for interfacial shear.	Testing performed; results support substantial equivalence.
Abrasion testing	Demonstrate acceptable abrasion resistance.	Testing performed; results support substantial equivalence.
Corrosion analysis (ASTM G5-14)	Demonstrate acceptable corrosion resistance.	Testing performed; results support substantial equivalence.
Chemical composition analysis (ASTM E2371, E1409, E1941-10, E1447-09)	Material composition matches specifications.	Testing performed; results support substantial equivalence.
Morphological evaluation	Surface morphology meets design specifications for porous coating.	Testing performed; results support substantial equivalence.
Biocompatibility testing	Be biocompatible.	Testing performed; results support substantial equivalence.
Bacterial Endotoxin Testing (ANSI/AAMI ST 72:2019)	Meet specified bacterial endotoxin limits.	Testing performed; results support substantial equivalence.
Technological Characteristics	Similar to predicate devices in principle of operation, intended use, classification, design, materials and fixation.	Detailed comparison provided, concluding similarity.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document lists various non-clinical tests. For these tests (fatigue, fixation, biocompatibility, coating characterization, etc.), the sample sizes are not explicitly stated in this summary. It is typical for these types of engineering tests to involve controlled laboratory specimens rather than patient data. Data provenance like country of origin or retrospective/prospective is not applicable here as these are laboratory tests, not clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. "Ground truth" in the context of expert consensus is relevant for diagnostic or AI performance studies rather than the engineering and material performance tests described for this knee implant. The "ground truth" for these tests is established by the specifications and acceptance criteria of the ASTM and ANSI/AAMI standards themselves.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this refers to a method used to resolve discrepancies in expert interpretation, which is not relevant for the non-clinical, objective engineering tests described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a knee implant, not an AI diagnostic device. No human-in-the-loop performance or MRMC studies were conducted for this type of device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as this is related to AI/diagnostic algorithms, not a knee implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" is defined by the established industry standards (e.g., ASTM F1800, ASTM F1044, ANSI/AAMI ST 72:2019). The tests measure physical properties against defined limits or performance benchmarks within these standards.

8. The sample size for the training set

Not applicable. This is a physical device, and the evaluation is based on non-clinical engineering and material tests, not on machine learning or AI models which would require training sets.

9. How the ground truth for the training set was established

Not applicable, for the same reason as point 8.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ 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, RingaskiddyCo. Cork Munster, IRELAND
Phone number	574-371-4945
Fax number	N/A
Establishment RegistrationNumber	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,and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology
Common or usual name	Total Knee Prosthesis
Classification name	Knee joint patellofemorotibial metal/polymer porous-coateduncemented prosthesis.Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
Class	II
Classification panel	87 Orthopedics
Regulation	Primary: 21 CFR 888.3565Secondary: 21 CFR 888.3560
Product Code(s)	Primary: MBHSecondary: JWH
Legally marketed device(s) towhich equivalence is claimed	Primary Predicate for ATTUNE Porous Fixed Bearing Tibial Base:DePuy ATTUNE Knee System, K101433Primary Predicate for ATTUNE Porous Medialized Dome Patella &Medialized Anatomic Patella:DePuy ATTUNE Medialized Dome and Anatomic Patellae, K103756Secondary Predicate for ATTUNE Porous Fixed Bearing Tibial Base:Triathlon Tritanium Tibial Baseplate, K123486Secondary Predicate for ATTUNE Porous Medialized Dome Patella &Medialized Anatomic Patella:Triathlon Tritanium Metal-Backed Patella, K132624Reference Devices:DePuy ATTUNE Cementless CR & PS Femoral Components, K140881
	DePuy ATTUNE Revision Knee System, K160700DePuy ATTUNE Total Knee System, K201347
Reason for 510(k) submission	Addition of new porous fixed bearing tibial bases and patellae devices to theATTUNE Knee System.
Device description	The ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patellaand Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology arecompatible with the ATTUNE Knee System composed of individuallypackaged femoral, tibial and patellar components designed to replace thenatural articular surface of the knee joint. The femoral component is a metalimplant with or without porous coating. The tibial component may becomprised of a metal tibial base with or without porous coating, and apolyethylene insert and locking components, or be an all polyethylene device.The patella component may be of an all polyethylene design or a polyethylenepatella with porous metal backing.
Intended use of the device	Total knee arthroplasty is intended to provide increased patient mobility andreduced pain by replacing the damaged knee joint articulation in patients wherethere is evidence of sufficient sound bone to seat and support the components.total knee replacement may be considered for younger patients if, in the opinionof the surgeon, an unequivocal indication for total knee replacement outweighsthe risks associated with the age of the patient, and if limited demands regardingactivity and knee joint loading can be assured. this includes severely crippledpatients with multiple joint involvement for whom a gain in knee mobility maylead to an expectation of significant improvement in the quality of their lives.
Indications for use	The ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patellaand Medialized Anatomic Patella with AFFIXIUM 3DP Technology areintended for cementless use within the ATTUNE® Total Knee ReplacementSystem. Porous coated implants may be used with or without cement.Candidates for total knee replacement include patients with a severelypainful and/or impaired knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate boneis 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 BaseCharacteristics	Subject Device:DePuy ATTUNE PorousFB Tibial Base withAFFIXIUM 3DPTechnology	Secondary Predicate Device:Stryker Triathlon TritaniumTibial BaseplateK123486	Primary Predicate Device:DePuy ATTUNE FB TibialBaseK101433
Material	Titanium Alloy ASTM F-136Titanium Alloy ASTM F-3001	Titanium Alloy ASTM F-136CP Titanium ASTM F-67	Cast Co-Cr-Mo alloyASTM 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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PatellaCharacteristics	Subject Device:DePuy ATTUNE PorousMedialized Dome andMedialized AnatomicPatellae with AFFIXIUM3DP Technology	Secondary Predicate Device:Stryker Triathlon TritaniumMetal-Backed PatellaK132624	Primary PredicateDevice:DePuy ATTUNEMedialized Dome andAnatomic PatellaeK103756
Material	Metal Back:Ti6Al4V Alloy(ASTM F-3001)Articulation Surface:AOX UHMWPE(ASTM F-648)	Metal Back:CP Titanium powder(ASTM F-1580)Articulation Surface:UHMWPE (ASTM F-648)	AOX UHMWPE(ASTM F-648)
Fixation	Cementless or Cemented	Cementless or Cemented	Cemented
Sizes	32, 35, 38, and 41 mm	Symmetric & AsymmetricSymmetric:31, 33, 36, 39 mmAsymmetric:S/I: 29, 32, 35, 38, 40M/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.

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
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.(b)
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.