(89 days)
The CEMSTOP Cement Restrictor is a diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during total hip arthroplasty. The CEMSTOP restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurization.
The CEMSTOP Cement Restrictor is inserted into the femoral canal prior to introduction of bone cement during total hip arthroplasty. It occludes the medullary canal and prevents the cement from flowing down the diaphysis and aids in cement pressurization. It is available in sizes. It is fabricated from gelatin and glycerol and is completely resorbed within a few days of implantation. The gelatin is porcine based.
This document is a 510(k) premarket notification for a medical device called the "CEMSTOP Cement Restrictor." It's a regulatory document from the FDA, not a study report. Therefore, it does not contain the acceptance criteria or a study proving the device meets those criteria in the format you requested.
The document states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to devices already approved by the FDA. This substantial equivalence is based on comparisons, not necessarily on a novel clinical trial or performance study against specific acceptance criteria.
Therefore, I cannot provide the information you requested about acceptance criteria and a study from this document.
Here's what the document does provide, which might be helpful in understanding why your request cannot be fulfilled by this particular text:
- Device Name: CEMSTOP Cement Restrictor
- Intended Use: A diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during total hip arthroplasty. It prevents cement from flowing down the diaphysis and facilitates cement pressurization.
- Material: Fabricated from gelatin and glycerol, completely resorbed within a few days of implantation. (Porcine-based gelatin).
- Predicate Devices: Exactly the same as cleared on K993841 by Encore Medical. Equivalent to BIOSTOP (Landos) cleared on K943727.
- Basis for Equivalence: Design, manufacturing method and facilities, packaging and sterilization are performed by the same company as the Encore Medical device.
To obtain the kind of performance data and acceptance criteria you're looking for, you would typically need to consult a clinical trial report, a risk assessment, or a specific performance testing document, not a 510(k) clearance letter.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2015
Teknimed, S.A. % Mr. J.D.Webb President OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K032685
Trade/Device Name: CEMSTOP Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: LZN Dated: August 27, 2003 Received: August 29, 2003
Dear Mr. Webb:
This letter corrects our substantially equivalent letter of November 26, 2003.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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Page 2 - Mr. J.D. Webb
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: CEMSTOP Cement Restrictor
Indications for Use:
CEMSTOP Cement Restrictor Indications for Use
10 (1
The CEMSTOP Cement Restrictor is a diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during total hip arthroplasty. The CEMSTOP restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurization.
h Mark n Milken
Division Sign-C Division of General, Restorative and Neurological Devi
510(k) Number K032685
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NOV 26 2003
510(k) Summary
104
Date August 27, 2003
Submitter
Teknimed, S.A. l l rue Apollo 31240 L'Union FRANCE
Contact person
J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199
Common name Cement restrictor
Classification name
Cement obturator
Equivalent Device
Exactly the same as cleared on K993841 by Encore Medical. Equivalent to BIOSTOP (Landos) cleared on K943727.
Device Description
The CEMSTOP Cement Restrictor is inserted into the femoral canal prior to introduction of bone cement during total hip arthroplasty. It occludes the medullary canal and prevents the cement from flowing down the diaphysis and aids in cement pressurization. It is available in sizes. It is fabricated from gelatin and glycerol and is completely resorbed within a few days of implantation. The gelatin is porcine based.
Intended Use
The CEMSTOP Cement Restrictor is a diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during total hip arthroplasty. The CEMSTOP restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurization.
Summary of Technological Characteristics Compared to Predicate Device
Design, manufacturing method and facilities, packaging and sterlization are performed by the same company as the Encore Medical device.
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§ 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.