(90 days)
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
This device is a total knee system indicated for various arthritic conditions and failed surgeries, aiming to improve joint function and alleviate symptoms, which aligns with the definition of a therapeutic device.
No
The device is a total knee system, which is an implant used for replacement, not a tool for diagnosing medical conditions.
No
The device description explicitly states that the components are "porous coated metal alloy devices," indicating a physical hardware component.
No, 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 and Intended Use: The provided text describes a surgical implant (a total knee system) used to replace a damaged knee joint. It is a physical device implanted in the body, not a test performed on a sample from the body.
The information clearly indicates this is a medical device used for surgical intervention, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The porous components of the Genesis II Total Knee System are single use devices for use without cement. The devices are indicated for:
-
- Rheumatoid arthritis.
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
-
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
- The posterior stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
Product codes
MBH
Device Description
The porous coated components of the Genesis II Total Knee System are designed for use with existing tibial and patellar components and accessories of the Genesis II Total Knee Systems cleared via K951987 and K953274. The subject components are porous coated metal alloy devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
older patients
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
A review of the mechanical test data indicated that the porous components of the Genesis II Total Knee System are equivalent to devices currently available and are capable of withstanding expected in vivo loading without failure.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
0
page lo fl
MAY 27 2003
Summary of Safety and Effectiveness Smith & Nephew, Inc. Genesis II Total Knee System
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 porous coated components of the Genesis II Total Knee System are designed for use with existing tibial and patellar components and accessories of the Genesis II Total Knee Systems cleared via K951987 and K953274. The subject components are porous coated metal alloy devices.
Device Classification Name
21 CFR 888.3565 (MBH) Knee joint patellofemorotibial metal/polymer/metal semiconstrained uncemented prosthesis - Class II
Indications for Use
The porous components of the Genesis II Total Knee System for Uncemented Use are single use devices for use without cement. The devices are indicated for:
-
- Rheumatoid arthritis.
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
-
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
- The posterior stabilized knee system is designed for use in patients in primary ধ: and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
Mechanical and Clinical Data
A review of the mechanical test data indicated that the porous components of the Genesis II Total Knee System are equivalent to devices currently available and are capable of withstanding expected in vivo loading without failure.
Substantial Equivalence Information
The substantial equivalence of the porous components of the Genesis II Total Knee System is substantiated by their similarities in design features, overall indications, and material composition as existing components of Total Knee Systems distributed by Smith & Nephew.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and features an abstract eagle design in the center. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the top half of the circle.
Public Health Service
MAY 27 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kim P. Kelly, MS Project Manager, Regulatory & Clinical Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116
Re: K030612
Trade/Device Name: Genesis II Total Knee System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: II Product Code: MBH Dated: February 25, 2003 Received: February 26, 2003
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
2
Page 2 - Ms. Kim P. Kelly, MS
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 vours.
Mark N. Milliken
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
3
030612
Genesis II Total Knee System Indications Statement
The porous components of the Genesis II Total Knee System are single use devices for use without cement. The devices are indicated for:
-
- Rheumatoid arthritis.
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
-
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
-
- The posterior stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
Mark N. Mulberron
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K030612
Concurrence of CDRH, Office of Device Evaluation
==============================================================================================================================================================================
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR (Per 21 CFR 801.109) Over-The Counter Use _________________________________________________________________________________________________________________________________________________________