SKELITE RESORBABLE CEMENT RESTRICTOR by MILLENIUM BIOLOGIX, INC.

The Skelite™ Resorbable Cement Restrictor is intended to be used in orthopaedic surgeries, such as those involving the femoral and tibia canals in hip stem and total knee replacement. This device is not appropriate for acetabular cup surgeries, nor is it intended for any spinal indications.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for the Skelite™ Resorbable Cement Restrictor. It does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria.

This letter is a regulatory document stating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It includes:

Trade/Device Name: Skelite™ Resorbable Cement Restrictor
Regulation Number and Name: 21 CFR 878.3300, Surgical mesh
Regulatory Class: II
Product Code: JDK
Date of Clearance: November 21, 2005
Intended Use: Orthopaedic surgeries involving femoral and tibia canals in hip stem and total knee replacement.
Limitations: Specifically states "THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. WARNING: THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED."

To answer your request about acceptance criteria and the supporting study, you would need to refer to the original 510(k) submission (K051836) itself, which is not provided here. The 510(k) submission would contain the detailed information on testing, performance data, and how the manufacturer demonstrated substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information from the given document as it is outside the scope of this regulatory clearance letter.

Summary

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 1 2005

Millenium Biologix, Inc. Robert Schiff, Ph.D., RAC, CQA (ASQ) President Schiff & Company 1129 Bloomfield Avenue West Caldwell, New Jersey 07006

Re: K051836

Trade/Device Name: Skelite™ Resorbable Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: October 27, 2005 Received: November 1, 2005

Dear Dr. Schiff:

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling and also as a Warning on the product label:

THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. WARNING:

THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.

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Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

If you desire specific information about the application of other labeling requirements to your device (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" (21 CFR 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,

Donna Roe Tillman, Ph.D., M.B.A.

onna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Not assigned yet

Device Name:

Skelite™ Resorbable Cement Restrictor

Indications for Use:

Prescription Use Var

Over-The-Counter Use: No

(Per 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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the-line-breaker

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number_K 051836

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.