(174 days)
Not Found
Not Found
No
The 510(k) summary describes a physical, resorbable plug and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No.
The device is described as a cement restrictor used during total hip arthroplasty to occlude the medullary cavity and prevent cement flow. It is an accessory for a surgical procedure to ensure proper cement pressurization, rather than directly treating a disease or condition itself.
No
Explanation: The device is described as a "cement restrictor" designed to occlude the medullary cavity during total hip arthroplasty to prevent cement flow and facilitate cement pressurization. Its function is interventional, not diagnostic.
No
The device description clearly states it is a physical "diaphyseal plug" made of a biocompatible material, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- CEMSTOP Function: The CEMSTOP cement restrictor is a physical device implanted inside the body during surgery (total hip arthroplasty). Its function is to physically block the flow of cement within the bone cavity. It does not perform any diagnostic tests on bodily samples.
The description clearly indicates a surgical implant used to facilitate a surgical procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for 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 pressurisation.
Product codes
LZN
Device Description
The CEMSTOP restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurisation. Biocompatible, this device is completely resorbed within several days at 37 ℃ and resists the temporary temperature rise generated by polymerisation of acrylic cement.
The CEMSTOP Cement Restrictor is available in diameters of 6mm, 8mm, 10mm, 12mm, 14mm, 16mm and 20mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Medullary cavity (during total hip arthroplasty)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BIOSTOP G Cement Restrictor (Landos, Inc.)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
MAY = 4 2000
K 993841
510(k) Summary of Safety and Effectiveness
-
(1) Submitter's name: Submitter's address: Submitter's telephone number: Contact person: Date summary prepared:
Encore Orthopedics, Inc. 9800 Metric Blvd. Austin. TX 78758 512) 834-6237 Debbie De Los Santos November 3, 1999 -
Trade or proprietary device name: CEMSTOP Cement Restrictor (2) Common or usual name: Cement restrictor Class II Classification name:
-
Legally marketed predicate device: BIOSTOP G Cement Restrictor (Landos, Inc.) (3)
(4) Subject device description:
The CEMSTOP restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurisation. Biocompatible, this device is completely resorbed within several days at 37 ℃ and resists the temporary temperature rise generated by polymerisation of acrylic cement.
The CEMSTOP Cement Restrictor is available in diameters of 6mm, 8mm, 10mm, 12mm, 14mm, 16mm and 20mm.
(ર) Subject device 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 pressurisation.
(6) Technological characteristics:
The CEMSTOP cement restrictor has the same technological characteristics (i.e., design and material) when compared to the predicate devices.
(7) Basis for substantial equivalence:
Features comparable to predicate devices include material, design and indications.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a series of flowing lines, possibly representing human profiles. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 4 2000
Ms. Debbie De Los Santos Regulatory/Clinical Specialist Encore 9800 Metric Boulevard Austin, Texas 78758
Re: K993841 Trade Name: CEMSTOP Cement Restictor Regulatory Class: II Product Code: LZN Dated: March 3, 2000 Received: March 6, 2000
Dear Ms. De Los Santos:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
2
Page 2 - Ms. Debbie De Los Santos
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you desire specific an invitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 1010-11-21 questions on the promotion and advertising of your device, (201) 594-4639. Truuntonally, 101 entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small monifacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Donne R. Kirchner
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
3
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
CEMSTOP Cement Restrictor_ Device Name: _
Indications For Use:
CEMSTOP Cement Restrictor Indications For Use
The CEMSTOP cement restrictor is a diaphyseal plug designed to occlude the medulary carity The CEMS I OF cement restrictor is a diaplyson progetting arthroplasty. The CEMSTOP restrictor before the introduction of acryne commit daring tour any would be facilitates cement pressurisation.
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _X (Per 21 CFR 801.109) OR
Over-The-Counter Use _
(Optional Format 1-2-96)_
Dmn R. Lochner.
(Division Sign-Off) (Division Sign-On)
Division of General Restorative Devices S10(k) Number L99384