The Vented Cement Restrictor used in cemented applications for hip, knee, and shoulder THE Vented Outlier (Sollieter Less The Vented Cement Restrictor features a ball valve which arthropiasty, is a polymorio abothe e stem, thus alleviating distal intra-medullary air pressure Surely Vonto an trapped chanufactured from either the above material or from a ceramic material.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any specific criteria. The document is a 510(k) summary for a "Vented Cement Restrictor", focusing on its description, intended use, and substantial equivalence to predicate devices, but it does not include details on performance studies with acceptance criteria, sample sizes, ground truth, or expert involvement.

Summary

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510(k) SUMMARY

SPONSOR NAME:	Amedica Corp.615 Arapeen DriveSuite 302Salt Lake City, Utah 84108
510(k) CONTACT:	Robert M. WolfarthPhone: (801) 583-5100E-Mail: Robert@AmedicaCorp.com
TRADE NAME:	Vented Cement Restrictor
COMMON NAME:	Instrument, Surgical, Sonic and Accessory/Attachment
CLASSIFICATION:	Instrument, Surgical, Sonic and Accessory/Attachment (ProductCode 87 JDX) are Class II per 21 CFR §888.4580, reviewed by theOrthopedic Devices panel.

PREDICATE DEVICES:

Amedica Vented Cement Restrictor (K022729) .
Quantum Orthopedics Cement Restrictor (K040276) .

DEVICE DESCRIPTION:

INTENDED USE:

The Vented Cement Restrictor is intended for use as a cement restrictor used in the treatment of the following:

Total Hip Arthroplasty .
Total Knee Arthroplasty .
Total or Hemi Shoulder Arthroplasty .

The device is not intended for use in spinal surgeries.

BASIS OF SUBSTANTIAL EQUIVALENCE:

Performance tests, design comparisons, and functional analyses conducted on the Vented r Chomiano total device that it is substantially equivalent to the predicate devices.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, which is a common symbol of the United States. The eagle is depicted in a simple, modern style.

APR 1 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert M. Wolfarth Director of Quality Assurance and Regulatory Affairs Amedica Corporation 615 Arapeen Drive, Suite 302 Salt Lake City, Utah 84108

Re: K050699

Trade/Device Name: Vented Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: JDK Dated: March 17, 2005 Received: March 18, 2005

Dear Mr. Wolfarth:

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 for assumer 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 r trass be actived a determination that your device complies with other requirements of the Act that I Drederal statutes and regulations administered by other Federal agencies. You must or uny I 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 Of It Fatt 6077, laceming (QS) regulation (21 CFR Part 820); and if applicable, the electronic rord in the quant) 35000 provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. Robert M. Wolfarth

This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotter with and n yourse FDA finding of substantial equivalence of your device to a legally prematic licultuation " " = " = " = " = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you active 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/industry/support/index.html.

Sincerely yours,

Stipt Rurls

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K650699

Device Name: _Vented Cement Restrictor

Indications for Use:

The Vented Cement Restrictor is intended for use as a cement restrictor used in the treatment of the following:

Total Hip Arthroplasty .
Total Knee Arthroplasty .
Total or Hemi Shoulder Arthroplasty .

The device is not intended for use in spinal surgeries.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Styph Purda

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(Division Sign Division of General, Restorative, and Neurological Devices

510(k) Number

(Posted November 13, 2003)

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.