The Avon Patello-femoral Joint Prosthesis is intended to be used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.

These components are single use only and are intended for implantation with bone cement.

Device Description

This submission covers the Avon femoral and patellar components of the Avon Patello-femoral Joint Prosthesis. The femoral components are manufactured from Cobalt Chrome (CoCr) and the patellar components are manufactured from Ultra-high Molecular Weight Polyethylene (UHMWPE) materials.

The purpose of this submission is to add Magnetic Resonance (MR) Conditional labeling to the labeling of the Avon femoral and patellar components of the Avon Patello-femoral Joint Prosthesis. Additionally, minor labeling and packaging updates, as detailed in the respective sections, are also included in this submission.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Avon Patello-femoral Joint Prosthesis) seeking clearance for minor labeling and packaging updates, specifically to add Magnetic Resonance (MR) Conditional labeling. This submission does not describe a study to prove the device meets acceptance criteria related to its clinical effectiveness or performance in a patient.

Instead, it describes non-clinical testing to demonstrate that the device is "MR Conditional" as per relevant ASTM standards. Therefore, many of the requested categories are not applicable to the information provided.

Here's the breakdown of what can be extracted:

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

Acceptance Criteria (Standard)	Reported Device Performance
Magnetically Induced Displacement Force:	It was concluded that the subject Avon femoral and patellar components... do not present a new worst case with respect to magnetically induced displacement force... Therefore, the Avon components are qualified to be "MR Conditional" for MR-induced displacement.
ASTM F2052-15: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
Magnetically Induced Torque:	It was concluded that the subject Avon femoral and patellar components... do not present a new worst case with respect to... torque... Therefore, the Avon components are qualified to be "MR Conditional" for... torque.
ASTM F2213-17: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
Image Artifact:	It was concluded that the subject Avon femoral and patellar components... do not present a new worst case with respect to... MR image artifacts... Therefore, the Avon components are qualified to be "MR Conditional" for... image artifacts.
ASTM F2119-07 (Reapproved 2013): Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
Heating by RF Fields:	It was concluded that the subject Avon femoral and patellar components... do not present a new worst case with respect to... RF-induced heating. Therefore, the Avon components are qualified to be "MR Conditional" for... RF-induced heating. The labeling has been modified to include the MR Conditional symbol and to provide the parameters for safe scanning.
ASTM F2182-19: Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging

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

This information is not provided. The testing was non-clinical (laboratory testing of the device components), not involving human subjects or patient data.

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)

Not applicable. The ground truth for the MR Conditional testing is established by the ASTM standards themselves, which define methodologies and criteria for measurement. No human experts were involved in establishing "ground truth" for this non-clinical testing.

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

Not applicable. This was non-clinical, objective testing against predefined engineering standards.

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 document is not about AI or diagnostic imaging interpretation. It is for a joint prosthesis and its MR compatibility.

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

Not applicable. This document is not about an algorithm, but a physical medical device.

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

The "ground truth" for the non-clinical testing was defined by adherence to published ASTM standards for MR compatibility. These are objective engineering and physics standards.

8. The sample size for the training set

Not applicable. This was non-clinical testing, not a machine learning study.

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

Not applicable. This was non-clinical testing, not a machine learning study.

Summary

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June 4, 2021

Howmedica Osteonics Corp., dba Stryker Orthopaedics

Shraddha More Staff Specialist, Regulatory Affairs 325 Corporate Dr. Mahwah, New Jersey 07430

Re: K211303

Trade/Device Name: Avon Patello-femoral Joint Prosthesis Regulation Number: 21 CFR 888.3540 Regulation Name: Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KRR Dated: April 27, 2021 Received: April 29, 2021

Dear Shraddha More:

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.

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

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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 mediation-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,

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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211303

Device Name Avon Patello-femoral Joint Prosthesis

Indications for Use (Describe)

These components are single use only and are intended for implantation with bone cement.

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

Sponsor	Howmedica Osteonics Corp. dba Stryker Orthopaedics325 Corporate DriveMahwah, NJ 07430
Contact Person	Shraddha MoreStaff Specialist, Regulatory AffairsHowmedica Osteonics Corp325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5804Email: shraddha.more@stryker.com
Alternate Contact	Margaret KlippelHowmedica Osteonics Corp325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5559Email: margaret.klippel@stryker.com
Date Prepared:	April 26, 2021
Proprietary Name:	Avon Patello-femoral Joint Prosthesis
Common Name:	Patello-femoral Joint Prosthesis
Classification Name:	Knee joint patellofemoral polymer/metal semi-constrained cementedprosthesis (21 CFR § 888.3540)
Product Codes:	KRR

Legally Marketed Devices to which Substantial Equivalence is Claimed:

Primary Predicate Device:

Avon Patello-femoral Joint Prosthesis (K051948) .

Reference Devices:

Avon Extra-small Patello-femoral Replacement (K041160) .
Avon Patellar Component (K020841) .
Avon Patello-femoral Joint Prosthesis (K010100) ●

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Device Description:

Indications for Use:

The indications for the subject components are as follows:

These components are single use only and are intended for implantation with bone cement.

Summary of Technological Characteristics:

There have been no changes to the technological characteristics of the subject Avon femoral and patellar components of the Avon Patello-femoral Joint Prosthesis as a result of the revision to the labeling. The subject components have the same design and are manufactured from the same materials as the predicate components.

Non-Clinical Testing:

The subject Avon femoral and patellar components of the Avon Patello-femoral Joint Prosthesis were evaulated as per the following standards:

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Magnetically Induced Displacement Force performed per ASTM F2052-15, Standard 0 Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
Magnetically Induced Torque performed per ASTM F2213-17, Standard Test Method ● for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
Image Artifact performed per ASTM F2119-07 (Reapproved 2013), Standard Test 0 Method for Evaluation of MR Image Artifacts from Passive Implants
o Heating by RF Fields per ASTM F2182-19. Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging

It was concluded that the subject Avon femoral and patellar components of the Avon Patellofemoral Joint Prosthesis do not present a new worst case with respect to magnetically induced displacement force, torque, MR image artifacts, and RF-induced heating. Therefore, the Avon components are qualified to be "MR Conditional" for MR-induced displacement, torque and image artifacts, and RF-induced heating.

The labeling has been modified to include the MR Conditional symbol and to provide the parameters under which a patient who has the device can be safely scanned in the MR environment.

Clinical Testing:

Clinical testing was not required as a basis for substantial equivalence.

Conclusion:

Based upon a comparison of the intended use, materials, summary of technological characteristics, and preclinical evaluation, the subject components are substantially equivalent to the respective predicate components identified in this premarket notification.

Regulation Number and Section

§ 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace part of a knee joint in the treatment of primary patellofemoral arthritis or chondromalacia. 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 a component made of alloys, such as cobalt-chromium-molybdenum or austenitic steel, for resurfacing the intercondylar groove (femoral sulcus) on the anterior aspect of the distal femur, and a patellar component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those devices intended for use with bone cement (§ 888.3027). The patellar component is designed to be implanted only with its femoral component.(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” and
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,”
(vii) ISO 7207-2:1998 “Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 2: Articulating Surfaces Made of Metal, Ceramic and Plastic Materials,” and
(viii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants,” and
(viii) F 1672-95 “Specification for Resurfacing Patellar Prosthesis.”

Re: K211303

Dear Shraddha More:

Indications for Use

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

Legally Marketed Devices to which Substantial Equivalence is Claimed:

Primary Predicate Device:

Reference Devices:

Device Description:

Indications for Use:

Summary of Technological Characteristics:

Non-Clinical Testing:

Clinical Testing:

Conclusion:

§ 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.

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