(84 days)
I'm sorry, but the Predicate Device(s) K/DEN number is not found in the provided text.
Not Found
No
The summary describes a mechanical knee implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
Explanation: The device is a knee implant intended to treat conditions like post-traumatic arthritis, degenerative arthritis, and failed previous surgeries, which are medical conditions, thereby providing therapeutic benefits to the patient.
No
The device description indicates it is a component for knee replacement, which is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a physical implant (femoral components) intended for surgical implantation, not software.
Based on the provided information, 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 Hybrid Knee Femoral Components are implants used to replace parts of the knee joint. This is a surgical device, not a diagnostic test performed on a sample.
- Intended Use: The intended use describes treating conditions like arthritis and failed previous surgeries by replacing parts of the knee, which is a therapeutic intervention, not a diagnostic one.
Therefore, the Hybrid Knee Femoral Components are a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Hybrid Knee Femoral Components are intended to be used for those patients whereby conditions exist that can not be solely addressed by a device that treats a single compartment (i.e. unicondylar or patellofemoral prosthesis) of the knee.
Indications include:
- post-traumatic arthritis; .
- degenerative arthritis; and .
- failed osteotomies, hemiarthroplasties; and unicompartmental . replacement
These indications will be used for the Hybrid Knee Femoral Components. whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.
The Hybrid Knee Femoral Components are single use only and are intended for implantation only with bone cement
Product codes
NPJ
Device Description
The Smith & Nephew Hybrid Knee Femoral Components are designed for use with tibial components of the Genesis I Unicondylar Knee System and patellar components of the Genesis II Total Knee System. The components are used to replace the medial condyle and patellofemoral regions of a femoral knee joint.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint, medial condyle and patellofemoral regions
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)
A review of the mechanical test data indicated that the Smith & Nephew Hybrid Knee Femoral Components are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. 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 prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Summary of Safety and Effectiveness
JAN 1 2 2005
Smith & Nephew, Inc.
Smith & Nephew Hybrid Knee Femoral Components
Contact Person and Address
Kim Kelly, Project Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc., Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 (901) 399-6566
Device Description
The Smith & Nephew Hybrid Knee Femoral Components are designed for use with tibial components of the Genesis I Unicondylar Knee System and patellar components of the Genesis II Total Knee System. The components are used to replace the medial condyle and patellofemoral regions of a femoral knee joint.
Device Classification Name
Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis, 21 CFR 888.3530
Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis, 21 CFR 888.3540
Indications for Use
The Hybrid Knee Femoral Components are intended to be used for those patients whereby conditions exist that can not be solely addressed by a device that treats a single compartment (i.e. unicondylar or patellofemoral prosthesis) of the knee.
Indications include:
- post-traumatic arthritis; .
- degenerative arthritis; and ●
- failed osteotomies, hemiarthroplasties; and unicompartmental replacement .
These indications will be used for the Hybrid Knee Femoral Components, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.
The Hybrid Knee Femoral Components are single use only and are intended for implantation only with bone cement.
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Mechanical and Clinical Data
A review of the mechanical test data indicated that the Smith & Nephew Hybrid Knee Femoral Components are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure.
Substantial Equivalence Information
The substantial equivalence of the Smith & Nephew Hybrid Knee Femoral Components is substantiated by its similarities in design features, overall indications, and material composition as existing components of the Genesis I Unicondylar Knee System and Genesis II Total Knee Systems distributed by Smith & Nephew, Inc., as well as other commercially available patellofemoral joint prostheses.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles an abstract caduceus, which is a traditional symbol of medicine.
JAN 1 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kim P. Kelly Project Manager Clinical and Regulatory Affairs Smith & Nephew, Inc., Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116
Re: K042896
Trade/Device Name: Hybrid Knee Femoral Components Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: NPJ Dated: October 19, 2004 Received: October 20, 2004
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. 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 - Mrs. Kelly
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/dsma/dsmamain.html
Sincerely yours,
Mark A. Milleros
Celia M. Witten, Ph.D., M.D.
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
510(k) Number (if known): K042896
Device Name: Hybrid Knee Femoral Components
Indications for Use:
The Hybrid Knee Femoral Components are intended to be used for those patients whereby conditions exist that can not be solely addressed by a device that treats a single compartment (i.e. unicondylar or patellofemoral prosthesis) of the knee.
Indications include:
- post-traumatic arthritis; .
- degenerative arthritis; and .
- failed osteotomies, hemiarthroplasties; and unicompartmental . replacement
These indications will be used for the Hybrid Knee Femoral Components. whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.
The Hybrid Knee Femoral Components are single use only and are intended for implantation only with bone cement
Prescription × AND/OR Use (Part 21 CFR 801 Subpart D)
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)
I. Restorative. and Neurologic
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510(k) Number