(95 days)
Not K-number listed
No
The summary describes a mechanical implant (patello-femoral joint prosthesis) and its components, with no mention of software, algorithms, or data processing that would typically involve AI/ML. The submission is a line extension for existing components.
Yes
The device is intended to treat degenerative arthritis, patellar dislocation, or patella fracture, aiming to address pain, deformity, or dysfunction. This constitutes a therapeutic purpose.
No
This device is a prosthesis intended for implantation during surgery, not for diagnosing medical conditions.
No
The device description clearly states it consists of physical components (cobalt-chromium femoral components and all-polyethylene components) intended for surgical implantation. It is a physical prosthesis, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a prosthesis for surgical implantation in the patellofemoral joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a joint prosthesis (femoral and patellar components made of cobalt-chromium and polyethylene). This is consistent with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the human body (blood, tissue, etc.) or to provide information about a patient's health status through in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a physical implant used to replace a damaged joint.
N/A
Intended Use / Indications for Use
The Avon" Patello-femoral Prosthesis is a single-use device intended for replacement of the femoral side of the patello-femoral joint. Indications and are listed below.
The Avon" Patello-femoral Joint Prosthesis is intended to be used in cemented patcHofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tuberele 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 (comma separated list FDA assigned to the subject device)
KRR
Device Description
The Avon® Patello-femoral Joint (PFJ) Prosthesis was cleared for marketing in K010100. K020841 and K041160. The current system consists of cobalt-chromium femoral components available in four sizes (extra small, small, medium, and large), and all-polyethylene components available in various sizes (small, medium. and large) and styles. This 510(k) submission is a line extension to the Avon "Patello-femoral Joint Prosthesis to add additional styles of patellar components to the system and update the labeling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patello-femoral joint, distal femur
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): 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.
Avon" PE1 Prosthesis
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.
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
Image /page/0/Picture/1 description: The image shows the text "K051948" in a handwritten style, followed by what appears to be a fraction symbol. Below this, the text "510(k) Premarket Notification" is printed in a smaller, more formal font. The image seems to be a document or label with a reference number and a brief description of its purpose.
OCT 2 1 2005
510(k) Summary of Safety and Effectiveness Avon® PFJ Prosthesis
| Submission Information
Name and Address of the Sponsor
of the 510(k) Submission: | Howmedica Osteonics Corp
325 Corporate Drive
Mahwah, NJ 07430 |
|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| For Information contact: | Vivian Kelly, Regulatory Affairs Specialist
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430
Phone: (201) 831-5581 Fax: (201) 831-6038 |
| Date Summary Prepared: | July 15, 2005 |
| Device Identification
Proprietary Name:
Common Name:
Classification Name and Reference:
Device Product Code: | Avon® Patello-femoral Joint Prosthesis
Patello-femoral arthroplasty
Knee joint patellofemoral polymer/metal semi-constrained
cemented prosthesis,
21 CFR 888.3540
OR (87) KRR |
Description:
The Avon® Patello-femoral Joint (PFJ) Prosthesis was cleared for marketing in K010100. K020841 and K041160. The current system consists of cobalt-chromium femoral components available in four sizes (extra small, small, medium, and large), and all-polyethylene components available in various sizes (small, medium. and large) and styles. This 510(k) submission is a line extension to the Avon "Patello-femoral Joint Prosthesis to add additional styles of patellar components to the system and update the labeling.
Intended Use:
The Avon" Patello-femoral Prosthesis is a single-use device intended for replacement of the femoral side of the patello-femoral joint. Indications and are listed below.
Indications for Use
The Avon" Patello-femoral Joint Prosthesis is intended to be used in cemented patcHofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tuberele elevation, lateral release) where pain, deformity or dysfunction persists. These components are single use only and are intended for implantation with bone cement.
Substantial Equivalence:
Avon * Patello-femoral Joint Prosthesis is substantially equivalent to the predicate Avon" PE1 Prosthesis in regards to design, materials, indications and operational principles. Testing demonstrated that the patellar components from the Duracon", Triathlon" and Scorpio" Knee Systems are compatible with the femoral components in Avon" PFJ Prosthesis.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol of three stylized human profiles. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the circular seal. The profiles are arranged in a row, with each one slightly overlapping the previous one.
OCT 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Vivian Kelly Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430
Re: K051948
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: II Product Code: KRR Dated: October 14, 2005 Received: October 17, 2005
Dear Ms. Kelly:
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.
2
Page 2 - Ms. Vivian Kelly
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.
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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
2
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K051948
Device Name: Avon® PFJ Prosthesis
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 arc intended for implantation with bone cement.
| Prescription Use | X | AND/OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| (Division Sign-Off) | Office of Device Evaluation (ODE) |
|---|---|
| --------------------- | ----------------------------------- |
Page 1 of 1
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K051948 |
|---|---|
| --------------- | --------- |