(60 days)
Joint replacement is indicated for patients suffering from disability due to:
- · degenerative, post-traumatic or rheumatoid arthritis;
- · avascular necrosis of the femoral condyle;
- · post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
- · moderate valgus, varus or flexion deformities;
This device may also be indicated in the salvage of previously failed surgical attempts.
While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
The modification system consists of a change to the Instructions for use to minimize the necessity for multiple IFU's and to update the contents to reflect current practice.
This document refers to an FDA 510(k) premarket notification for knee replacement components. The original submission (K063406) appears to be related to a change to the Instructions for Use for several existing devices, not a new device or significant modification requiring extensive clinical testing to prove safety and effectiveness.
Therefore, the typical structure for acceptance criteria and a study proving device performance (e.g., diagnostic accuracy, clinical outcomes) is not applicable here. This submission is about administrative changes to existing devices.
The key phrase in all provided documents is: "The modification system consists of a change to the Instructions for use to minimize the necessity for multiple IFU's and to update the contents to reflect current practice."
The FDA's decision is stated in Document 4 and 5: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
This indicates that the FDA deemed the changes to the Instructions for Use to not alter the fundamental safety or effectiveness of the previously cleared devices, and thus did not require new performance studies. The "acceptance criteria" here are instead related to regulatory equivalence.
If this were a true new device or a significant modification, the information requested would be relevant. However, for a change to an IFU, the "acceptance criteria" are:
- The revised Instructions for Use (IFU) do not introduce new risks.
- The revised IFU do not significantly alter the indications for use or mechanism of action.
- The revised IFU maintain substantial equivalence to the predicate device in terms of safety and effectiveness.
The "study that proves the device meets the acceptance criteria" in this context is the review by the FDA based on the provided documentation, which likely included:
- A comparison of the old IFU with the new IFU.
- A justification for the changes, perhaps referencing current clinical practice standards or updated scientific literature.
- Confirmation that the changes did not alter the intended use or fundamental performance characteristics of the physical device.
Therefore, I cannot provide the requested table and study details as they would typically apply to a performance study of a new or significantly modified medical device. This submission is primarily administrative and regulatory, not performance-based.
{0}------------------------------------------------
Summary of Safety and Effectiveness
JAN - 8 2007
Date: November 8, 2006
Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758
Regulatory Affairs Specialist
Email: Teffany Hutto(@encoremed.com
Phone: (512) 834-6255
Fax: (512) 834-6313
Contact Person:
Teffany Hutto
Trade Name: Foundation Lateral Pivot Insert
Common Name: Tibial Insert
Classification Name: Knee joint patellofemorotibial polymer/ metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3560
Description: The modification system consists of a change to the Instructions for use to minimize the necessity for multiple IFU's and to update the contents to reflect current practice.
Intended Use: Joint replacement is indicated for patients suffering from disability due to:
- · degenerative, post-traumatic or rheumatoid arthritis;
- · avascular necrosis of the femoral condyle;
- · post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
- · moderate valgus, varus or flexion deformities;
This device may also be indicated in the salvage of previously failed surgical attempts.
{1}------------------------------------------------
KO63406
Summary of Safety and Effectiveness
Date: November 8, 2006
Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758
Contact Person: Teffany Hutto Regulatory Affairs Specialist Phone: (512) 834-6255 Fax: (512) 834-6313 Email: Teffany Hutto@encoremed.com Trade Name: Foundation Plasma Sprayed Femoral Component
Common Name: Femoral Knee Component
Classification Name: Knee joint patellofemorotibial polymer/ metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3560
The modification system consists of a change to the Instructions for use to Description: minimize the necessity for multiple IFU's and to update the contents to reflect current practice.
Intended Use: Joint replacement is indicated for patients suffering from disability due to:
- · degenerative, post-traumatic or rheumatoid arthritis:
- · avascular necrosis of the femoral condyle;
- · post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
- · moderate valgus, varus or flexion deformities;
This device may also be indicated in the salvage of previously failed surgical attempts.
{2}------------------------------------------------
KC63406
Summary of Safety and Effectiveness
Date: November 8, 2006
Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758
Contact Person: Teffany Hutto Regulatory Affairs Specialist Phone: (512) 834-6255 Fax: (512) 834-6313 Email: Teffany Hutto@@encoremed.com Trade Name: Foundation Ultra Congruent Tibial Insert
Common Name: Tibial Insert
Classification Name: Knee joint patellofemorotibial polymer/ metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3560
The modification system consists of a change to the Instructions for use to Description: minimize the necessity for multiple IFU's and to update the contents to reflect current practice.
Intended Use: Joint replacement is indicated for patients suffering from disability due to:
- · degenerative, post-traumatic or rheumatoid arthritis;
- · avascular necrosis of the femoral condyle;
- · post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
- · moderate valgus, varus or flexion deformities;
This device may also be indicated in the salvage of previously failed surgical attempts.
{3}------------------------------------------------
Summary of Safety and Effectiveness
Date: November 8, 2006
Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758
Contact Person: Teffany Hutto Regulatory Affairs Specialist Phone: (512) 834-6255 Fax: (512) 834-6313 Email: Teffany Hutto@encoremed.com Trade Name: MJS Posterior Stabilized Knee
Common Name: Total Knee System
Classification Name: Knee joint femorotibial metal/polymer semiconstrained cemented prosthesis per 21 CFR 888.3530
The modification system consists of a change to the Instructions for use to Description: minimize the necessity for multiple IFU's and to update the contents to reflect current practice.
Intended Use: Joint replacement is indicated for patients suffering from disability due to:
- · degenerative, post-traumatic or rheumatoid arthritis;
- · avascular necrosis of the femoral condyle;
- · post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
- · moderate valgus, varus or flexion deformities;
This device may also be indicated in the salvage of previously failed surgical attempts.
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Encore Medical % Ms. Teffany Hutto Regulatory Affairs Specialist 9800 Metric Boulevard Austin, Texas 78758
Re: K063406
Trade/Device Name: Encore Knee System IFU Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: November 8, 2006 Received: November 21, 2006
JAN - 8 2007
Dear Ms. Hutto:
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.
{5}------------------------------------------------
Page 2 – Ms. Teffany Hutto.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
510(k) Number (if known): KO6 3 Y Ob
Device Name: MJS Posterior Stabilized Knee
Indications for Use:
MJS Posterior Stabilized Knee Indications for Use
Joint replacement is indicated for patients suffering from disability due to:
- · degenerative, post-traumatic or rheumatoid arthritis;
- · avascular necrosis of the femoral condyle;
- · post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
- · moderate valgus, varus or flexion deformities;
This device may also be indicated in the salvage of previously failed surgical attempts.
While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Paul
OR
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
VOL2401 510(k) Number.
§ 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.