(16 days)
Not Found
No
The device description focuses on the chemical composition and physical properties of bone cement, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is a bone cement used for the fixation of joint prostheses to host bone in various orthopedic procedures, which directly addresses a medical condition or disability.
No
The device is a bone cement used for fixation of prostheses, not for diagnosing medical conditions.
No
The device description clearly outlines the chemical constituents of a bone cement, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of joint prostheses to bone during surgical procedures. This is a direct application within the body (in vivo).
- Device Description: The device is a bone cement, a material used to physically bond prostheses to bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples for diagnostic purposes. This bone cement is used inside the body for a structural purpose.
N/A
Intended Use / Indications for Use
CEMEX SYSTEM bone cement is intended to be used for the fixation of plastic and metal joint prostheses to host bone.
CEMEX SYSTEM bone cement is indicated for the fixation of prostheses to bone in orthopaedic musculoskeletal procedures for osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, tramatic arthritis, congenital deformities, avascular necrosis, post-traumatic degenerative problems of the joint, sickle cell anemia, osteoporosis, collagen disease and for the revision of previous arthroplasty procedures.
Product codes (comma separated list FDA assigned to the subject device)
LOD
Device Description
The individual chemical constituents in Cemex System Fast bone cement are identical to those in the predicate Cemex System cement (#K000943). The liquid component contains methylmethacrylate, N-N dimethyl p-toluidine, and hydroquinone. The dry powder component contains polymethylmethacrylate, barium sulphate and benzoyl peroxide. The only difference is that the predicate Cemex System has a 2.7:1 powder-toliquid ratio compared to the 2.4:1 ratio the new Cemex System Fast product. The powder-to-liguid ratio reduction results in a quicker setting time to accommodate various application techniques.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
0
Exactech, Inc. Tecres Cemex® System Fast Bone Cement
Special 510(k) Summary of Safety and Effectiveness
MAY 22 2003
| Trade Names: | Cemex System Fast |
|---|---|
| Common Name: | Bone Cement |
| Classification Name: | Polymethylmethacrylate (PMMA) |
| Bone Cement |
Legally Marketed Devices for Substantial Equivalence Comparison:
| Model | Manufacturer | 510(k)# |
|---|---|---|
| Cemex System | Tecres, S.p.A. | #K000943 |
Device Description:
INTENDED USE
CEMEX SYSTEM bone cement is intended to be used for the fixation of plastic and metal joint prostheses to host bone.
INDICATIONS FOR USE
CEMEX SYSTEM bone cement is indicated for the fixation of prostheses to bone in orthopaedic musculoskeletal procedures for osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, tramatic arthritis, congenital deformities, avascular necrosis, post-traumatic degenerative problems of the joint, sickle cell anemia, osteoporosis, collagen disease and for the revision of previous arthroplasty procedures.
CONTRAINDICATIONS
CEMEX SYSTEM bone cement is contraindicated in the presence of active or incompletely treated infection which could involve the site where the cement is to be applied.
CEMEX SYSTEM bone cement is contraindicated where the loss of musculature or neuromuscular compromise in the affected limb would render the surgical procedure unjustifiable.
CEMEX SYSTEM bone cement is contraindicated in patients who are allergic to any of its components.
Section 4 Page 2 of 3
1
Exactech, Inc. Tecres Cemex® System Fast Bone Cement
Special 510(k) Summary of Safety and Effectiveness
GENERAL DESCRIPTION -- Substantial Equivalency Information
The individual chemical constituents in Cemex System Fast bone cement are identical to those in the predicate Cemex System cement (#K000943). The liquid component contains methylmethacrylate, N-N dimethyl p-toluidine, and hydroquinone. The dry powder component contains polymethylmethacrylate, barium sulphate and benzoyl peroxide. The only difference is that the predicate Cemex System has a 2.7:1 powder-toliquid ratio compared to the 2.4:1 ratio the new Cemex System Fast product. The powder-to-liguid ratio reduction results in a quicker setting time to accommodate various application techniques.
PACKAGING
The Cemex System Fast has identical packaging as the predicate CEMEX System. The product is contained in a double blister pack sealed with Tyvek® lids. The outer packaging is a heavy weight cardboard box.
MIXING & APPLICATION
Use of Cemex System Fast bone cement takes place in two consecutive stages. During the first stage, the glass ampoule containing the liquid monomer is broken to allow the component to flow into the chamber containing the powdered constituents. The device is then used as a closed manual mixing device. Mixing is accomplished by firmly striking the device against the palm of the hand and rotating at each strike. Because no direct contact is made between the components and the user, volitile release into the local environment and possibility of contamination is minimized. In the second stage, the container is attached to an application gun device and used as a syringe while the cement is still in a semi-fluid state. The transparency of the mixing device provides for preliminary inspection of the suitability of the cement components and the visualization of the mixing and application stages as required by ISO 5833. Detailed instructions for use and precaution/warning information is outlined in the instruction leaflet provided with the product.
STERILITY ASSURANCE
The powdered component is sterilized by ethylene oxide (EO) to a Sterility Assurance Level (SAL) of 10 . The liquid component is sterilized by a membrane filtration technique to a SAL of 10-3.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 22 2003
Ms. Lisa Simpson Regulatory Representative Exactech, Inc. 2320 NW 66th Court Gainesville, FL32653
Re: K031430
Trade Name: Tecres Cemex System Fast Bone Cement Regulation Number: 21 CRF 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: May 5, 2003 Received: May 6, 2003
Dear Ms. Simpson:
We have reviewed your Section 510(k) premarket 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) 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.
3
Page 2 - Ms. Lisa Simpson
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Sincerely yours,
Mark A. Wilkerson
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
4
Tecres Cemex System Fast Bone Cement
Indications for Use
ko31430 510(k) Number:
Device Names: Cemex System Fast Bone Cement
INTENDED USE
CEMEX bone cement is intended to be used for the fixation of artificial joint prostheses to the host bone.
INDICATIONS FOR USE
CEMEX bone cement is indicated for the fixation of protheses to bone in orthopaedic musculoskeletal procedures for osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, tramatic arthritis, congenital deformities, avascular necrosis, post-traumatic degenerative problems of the joint, sickle cell anemia, osteoporosis, collagen disease and for the revision of previous arthroplasty procedures.
CONTRAINDICATIONS
CEMEX bene cement is contraindicated in the presence of active or incompletely treated infection which could involve the site where the cement is to be applied.
CEMEX bone cement is contraindicated where the loss of musculature or neuromuscular compromise in the affected limb would render the surgical procedure unjustifiable.
CEMEX bone cement is contraindicated in patients who are allergic to any of its components
Mark N Mellase
Division Sign-Off Division of Ceveral. Restorative and Neurological Devices
Please do not write below this line usqandist natumber
Concurrence of CDRH, Office of Device Evaluation (ODE)
or
Prescription Use
$\searrow$
Over the Counter Use
Section 3 Page 1 of 1