(24 days)
No
The description focuses solely on the physical components and intended use of a joint replacement prosthesis, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a patellofemoral joint replacement, which is explicitly described as being used in cemented patellofemoral arthroplasty for patients with degenerative arthritis, patellar dislocation, or fracture, all of which are conditions that constitute a disease or injury that the device is intended to treat.
No
The provided text describes a prosthetic device intended for joint replacement, not for diagnosing medical conditions.
No
The device description clearly states it consists of physical components made of cobalt-chromium and all-polyethylene, intended for surgical implantation. This is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Avon™ Patello-femoral Joint Replacement is a prosthesis intended for implantation with bone cement to replace the patellofemoral joint. This is a surgical implant, not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended use describes treating conditions like degenerative arthritis, patellar dislocation, and failed previous surgeries by replacing the joint. This is a therapeutic intervention, not a diagnostic process.
Therefore, the Avon™ Patello-femoral Joint Replacement falls under the category of a surgical implant or prosthesis, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
KRR
Device Description
The Avon™ Patello-femoral Joint Prosthesis (clearcd for marketing in K010100 and K020841) 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patellofemoral joint, distal femur, 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
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 888.3540 |
| Knee 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 888.3540 |
| Knee joint patellofemoral polymer/metal semi- | |
| constrained cemented prosthesis | |
| Predicate Product Code: | OR (87) KRR |
| For Information contact: | Margaret F. Crowe |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, 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)
1
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.
2
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
3
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
4
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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