(24 days)
The Avon™ Patello-femoral Joint Replacement 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.
The Avon™ Patello-femoral Joint Prosthesis is intended to be used in the replacement of the patellofemoral joint in patients with degenerative arthritis of 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 current system consists of cobaltchromium femoral components available in three sizes (small, medium, and large), and allpolyethylene components available in three sizes (small, medium, and large). These components are intended to be implanted using bone cement. It is the intention of Stryker Howmedica Osteonics to introduce an extra-small Avon™ Patellofemoral replacement component. The extra-small Avon™ femoral component differs from the previously released small Avon™ femoral component in the following ways: 1. The width of the patellar flange is reduced by 3mm (small 46.5mm; extra-small: 43.5mm) 2. The intra-condylar distal flange hcight is reduced by 1.5mm (small 19.5; extra-small 18.0mm) This component is also intended to be implanted using bone cement. The Avon™ Extra-Small Patello-femoral Replaccment component is a single-use device intended for replacement of the femoral side of the patello-femoral joint.
The provided text describes a medical device submission (K041160) for a "Line Extension to Avon™ Patello-femoral Replacement System - Extra-Small Femoral Component." This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device.
Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or MRMC studies.
Instead, it describes changes made to an existing, cleared device (Avon™ Patello-femoral Joint Prosthesis, cleared in K010100 and K020841) to introduce an "extra-small" size. The justification for clearance is based on the technological comparison to the predicate device, specifically highlighting the dimensional changes in the extra-small femoral component:
- 1. The width of the patellar flange is reduced by 3mm (small 46.5mm; extra-small: 43.5mm)
- 2. The intra-condylar distal flange height is reduced by 1.5mm (small 19.5; extra-small 18.0mm)
The FDA's letter states, "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." This substantial equivalence determination is based on the comparison to the predicate, not on a new clinical study with specific performance criteria.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document's purpose is to show equivalence through design comparison, not to present a new study with acceptance criteria for device performance.
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MAY 27 2004
K041160 - Page 1 of 2
Line Extension to Avon™ Patello-femoral Replacement System
Special 510(k) Premarket Notification
Special 510(k) Summary
| Proprietary Name: | Avon™ Extra-small Patello-femoral Replacement |
|---|---|
| Common Name: | Patello-femoral Replacement |
| Classification Name and Reference: | 21 CFR 888.3540Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | OR (87) KRR |
| Predicate Proprietary Name: | Avon™ Small Patello-femoral Replacement |
| Predicate Regulatory Class: | 21 CFR 888.3540Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis |
| Predicate Product Code: | OR (87) KRR |
| For Information contact: | Margaret F. CroweHowmedica Osteonics Corp.325 Corporate DriveMahwah, New Jersey 07430 |
| Phone: (201) 831-5580 | |
| Fax: (201) 831-6038 |
Description/Technological Comparison
The Avon™ Patello-femoral Joint Prosthesis (clearcd for marketing in K010100 and K020841)
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K041160 - Page 2 of 2
I ine Extension to Avon3M Patello-femoral Replacement System
Special 510(k) Premarket Notification
is intended to be used in the replacement of the patellofemoral joint in patients with degenerative arthritis of 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 current system consists of cobaltchromium femoral components available in three sizes (small, medium, and large), and allpolyethylene components available in three sizes (small, medium, and large). These components are intended to be implanted using bone cement.
It is the intention of Stryker Howmedica Osteonics to introduce an extra-small Avon™ Patellofemoral replacement component. The extra-small Avon™ femoral component differs from the previously released small Avon™ femoral component in the following ways:
-
- The width of the patellar flange is reduced by 3mm (small 46.5mm; extra-small: 43.5mm)
-
- The intra-condylar distal flange hcight is reduced by 1.5mm (small 19.5; extra-small 18.0mm)
This component is also intended to be implanted using bone cement.
Intended Use
The Avon™ Extra-Small Patello-femoral Replaccment component is a single-use device intended for replacement of the femoral side of the patello-femoral joint.
The Avon™ Patello-femoral Joint Replacement 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.
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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 7 2004
Ms. Lorraine T. Montemurro Regulatory Affairs Manager Stryker Howmedica Osteonics 325 Corporate Drive Mahwah, New Jersey 07430
Re: K041160
Trade/Device Name: Line Extension to Avon" Patello-femoral Joint Replacement - Extra-Small Femoral Component Regulation Number: 21 CFR 888.3540 Regulation Name: Knee joint patellofemoral polymer/metal semi-constrained cemented
prosthesis
Regulatory Class: II Product Codes: KRR Dated: April 30, 2004 Received: May 3, 2004
Dear Ms. Montemurro:
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
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Page 2 - Ms. Lorraine T. Montemurro
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.
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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 yours,
Mark H. Wilkerson
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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Kot 1160
Indications for Use
510(k) Number (if known): Device Name: Line Extension to Avon™ Patello-femoral Joint Replacement - Extra-Small Femoral Component
Indications For Use:
The Avon™ Patello-femoral Joint Replacement is intended to be used in comented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patclla, 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.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milkerson
Division of General, Restorative, and Neurological Devices
510(k) Number K091160
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