(90 days)
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.
The provided document is a 510(k) premarket notification for the Smith & Nephew, Inc. Genesis II Total Knee System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical trial data with predefined acceptance criteria for device performance.
Therefore, many of the requested elements for a study proving acceptance criteria are not directly applicable or available in this document.
Here's a breakdown based on the information provided and the nature of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Equivalence: Capable of withstanding expected in vivo loading without failure. | "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." |
| Design Features, Overall Indications, and Material Composition Equivalence: Similarity to existing components of Total Knee Systems distributed by Smith & Nephew. | "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." |
| Safety and Effectiveness: Demonstrated by substantial equivalence to predicate devices (which are assumed to be safe and effective). | The FDA's substantial equivalence determination implies that the device is considered safe and effective for its stated indications for use, based on its similarity to legally marketed predicate devices. (This is a regulatory "acceptance" rather than a performance metric.) |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable in the context of this 510(k) submission. Mechanical testing was performed, but specific sample sizes and data provenance for these internal tests are not detailed. The submission relies on a comparison to existing devices, not a new clinical trial with a "test set" of patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth in a clinical sense (e.g., diagnosis, outcome) is not established within this 510(k) submission. The "ground truth" for the submission is the regulatory acceptance of existing predicate devices.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical "test set" requiring adjudication in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document does not describe any MRMC comparative effectiveness study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a physical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used for this 510(k) submission is the regulatory acceptance and established safety/effectiveness profile of predicate devices that were already legally marketed. The submission demonstrates that the new device is "substantially equivalent" to these predicates.
8. The Sample Size for the Training Set
Not applicable. This device is a physical implant, not a machine learning model. There is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable (as above).
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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.
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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
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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
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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
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Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR (Per 21 CFR 801.109) Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
§ 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.