(27 days)
Not Found
No
The summary describes a mechanical implant with a design modification (a blend radius). There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
Yes
The device is a patellar component intended for use in joint replacement to treat degenerative arthritis, patellar dislocation, or patella fracture, which are conditions that impair normal bodily function. This aligns with the definition of a therapeutic device designed to restore or improve health.
No
The provided text describes a patellar component and a patello-femoral joint prosthesis intended for surgical replacement, not for diagnosis.
No
The device description clearly states it is a physical component, an "all polyethylene patellar component," intended for surgical implantation. It is a modification of an existing physical medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The provided text describes a patellar component and a patello-femoral joint prosthesis. These are implantable medical devices designed to replace parts of the knee joint. They are used within the human body during surgery.
- Intended Use: The intended use is for patellofemoral arthroplasty (joint replacement surgery) in patients with specific conditions affecting the knee joint. This is a surgical procedure, not a diagnostic test performed on a specimen.
The device is a surgical implant, not a diagnostic tool used on samples outside the body.
N/A
Intended Use / Indications for Use
The subject Avon™ Patellar Component is intended to be used with the Avon™ Patello-Femoral Joint Replacement in replacement of the patello-femoral joint. The subject Avon™ patellar component is a modification of the Kinemax® All Polyethylene Patellar Component. The Avon" Patellar Component has been modified to include the addition of a blend radius on the medial aspect of the patella. This blend is designed to reduce the contact stress of the patella on the patello-femoral component. The rest of the design features of the Avon patellar component are identical to that of the previous released Kinemax® All Polyethylene Patellar Component.
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.
The Avon™ Patellar Component and the Avon™ Patello-femoral Joint Prosthesis are intended for use with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
KRR
Device Description
The Avon™ Patellar Component is a modification of the Kinemax® Plus All Polyethylene Patellar Component. The modified device will be marketed as the Avon Patellar Component. This all polyethylene patellar component will be used to articulate with the cobalt-chromium alloy femoral component of the Avon™ Patello-femoral Joint Replacement. The subject Avon™ Patellar Component is identical in design features with the exception of the following: a blend radius has been added on the articular surface of the patella in order to reduce the potential for impingement of the patellar component on the bone. No other changes have been made to the design of the patellar component.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patello-femoral joint, 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)
Design controls were utilized to identify the risks associated with the modified device. Testing was presented to address these risks. A Declaration of Conformity was included.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
APR 1 1 2002
Special 510(k) Notification - Design Modification to the Kinemax® Patellar Component
Confidential
Special 510(k) Summary - Device Modification for the Kinemax® All Polyethylene Patellar Component to be marketed as the Avon™ Patellar Component
Proprietary Name:
Avon™ Patellar Component
Common Name:
All Polvethylene Patellar Component
Classification Name and Reference:
Knee Joint Patellofemoral Polymer/Metal Semi-Constrained Cemented Prosthesis
Proposed Regulatory Class:
Class II
Device Product Code:
OR (87) KRR
21 CFR 888.3540
The Avon" Patello-femoral Joint Replacement (found substantially equivalent in K010100) is intended to be used with the legally marketed Kinemax® Plus All Polyethylene Patellar Component in cemented replacement of the patello-femoral joint in patients with degenerative arthritis of the distal femur and patients with a history of patellar dislocation or fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release).
It is the intention of Howmedica Osteonics Corp. to modify the Kinemax® Plus All Polyethylene Patellar Component. The modified device will be marketed as the Avon Patellar Component. This all polyethylene patellar component will be used to articulate with the cobalt-chromium alloy femoral component of the Avon™ Patello-femoral Joint Replacement.
The subject Avon™ Patellar Component is identical in design features with the exception of the following: a blend radius has been added on the articular surface of the patella in order to reduce the potential for impingement of the patellar component on the bone.
No other changes have been made to the design of the patellar component. The Avon™
1
Patellar Component will be available for use with bone cement in patello-femoral replacement surgery.
Design controls were utilized to identify the risks associated with the modified device. Testing was presented to address these risks. A Declaration of Conformity was included.
For Information contact:
Margaret F. Crowe, Regulatory Affairs Consultant Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-2584 (201) 934-4359 Fax: (201) 760-8435
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with outstretched arms, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
APR 1 1 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. William J. Cymbaluk Vice President, Quality Assurance/Regulatory Affairs/Clinical Research Stryker Howmedica Osteonics 59 Route 17 Allendale, NJ 07401-1677
Re: K020841
Trade Name: Avon™ Patellar Component 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: March 14, 2002 Received: March 15, 2002
Dear Mr. Cymbaluk:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. William J. Cymbaluk
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Mark N. Mulkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Avon™ Patellar Component Device Name:
Indications for Use:
The subject Avon™ Patellar Component is intended to be used with the Avon™ Patello-Femoral Joint Replacement in replacement of the patello-femoral joint. The subject Avon™ patellar component is a modification of the Kinemax® All Polyethylene Patellar Component. The Avon" Patellar Component has been modified to include the addition of a blend radius on the medial aspect of the patella. This blend is designed to reduce the contact stress of the patella on the patello-femoral component. The rest of the design features of the Avon patellar component are identical to that of the previous released Kinemax® All Polyethylene Patellar Component.
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.
The Avon™ Patellar Component and the Avon™ Patello-femoral Joint Prosthesis are intended for use with bone cement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use yes OR Over-The-Counter Use No
(Per 21 CFR 801.109) (Optional Format 1-2-96)
for Mark n Mellman
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number _K020841****_