(36 days)
No
The summary focuses on the physical components of a joint prosthesis and testing related to MR compatibility. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
Explanation: The device is a prosthetic joint replacement intended to address anatomical and functional issues (degenerative arthritis, patellar dislocation, fracture, failed surgery) rather than actively treat a disease or condition. It replaces a part of the body, which is a structural intervention, not a therapeutic one in the typical medical sense of curing or alleviating a disease process.
No
The device is a prosthesis intended for implantation to replace patellofemoral joints, not to diagnose medical conditions.
No
The device is a physical implant (femoral and patellar components made of CoCr and UHMWPE) and the submission is for adding MR Conditional labeling and minor updates, not for a software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description: The provided text describes a surgical implant (a joint prosthesis) intended to be placed inside the body to replace a damaged joint.
- Intended Use: The intended use clearly states it's for "cemented patellofemoral arthroplasty," which is a surgical procedure.
- No mention of testing biological samples: The description focuses on the physical components of the prosthesis and their performance in an MR environment, not on analyzing biological samples.
Therefore, based on the provided information, the Avon Patello-femoral Joint Prosthesis is a medical device, specifically a surgical implant, and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
KRR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
distal femur and patella
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
The subject Avon femoral and patellar components of the Avon Patello-femoral Joint Prosthesis were evaulated as per the following standards:
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
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
1
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
2
Indications for Use
510(k) Number (if known) K211303
Device Name Avon Patello-femoral Joint Prosthesis
Indications for Use (Describe)
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.
| 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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3
510(k) Summary
| Sponsor | Howmedica Osteonics Corp. dba Stryker Orthopaedics
325 Corporate Drive
Mahwah, NJ 07430 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Shraddha More
Staff Specialist, Regulatory Affairs
Howmedica Osteonics Corp
325 Corporate Drive
Mahwah, NJ 07430
Phone: (201) 831-5804
Email: shraddha.more@stryker.com |
| Alternate Contact | Margaret Klippel
Howmedica Osteonics Corp
325 Corporate Drive
Mahwah, NJ 07430
Phone: (201) 831-5559
Email: 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 cemented
prosthesis (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) ●
4
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.
Indications for Use:
The indications for the subject components are as follows:
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.
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:
5
- 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.