(20 days)
INTENDED USE: CEMEX bone cement is intended to be used for the fixation of plastic and metal joint prostheses to host bone.
INDICATIONS FOR USE: CEMEX 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.
The chemical constituents in CEMEX RX, ISOPLASTIC, and XL bone cements 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. Like the predicate CEMEX SYSTEM Bone Cement (#K000943), the ratio between the powder and liquid components of the proposed cements is 3:1. The proportion of each ingredient in the ISOPLASTIC and RX models varies slightly from the predicate model. The XL bone cement formulation is identical to that of CEMEX SYSTEM (#K000943). The differences result in a range of viscosities to accommodate various application techniques.
The provided text describes a 510(k) premarket notification for the Exactech, Inc. Tecres Cemex® System Bone Cement. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a de novo study with reported performance metrics.
Therefore, the input document does not contain the information requested regarding acceptance criteria, reported device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or detailed ground truth establishment methods for a new device study.
The document mainly identifies the device, its intended use, indications for use, contraindications, and lists predicate devices to which it claims substantial equivalence based on chemical composition and manufacturing similarities. The FDA letter confirms the substantial equivalence determination.
Here's how the requested information relates to the provided text:
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A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on demonstrating that the new Cemex cements are chemically and functionally similar to existing, legally marketed bone cements (predicates) and the previously cleared Cemex System. It doesn't report new performance data against specific acceptance criteria for this 510(k). For a medical device like bone cement, "performance" would typically involve mechanical properties (tensile strength, compressive strength, fatigue life), biocompatibility, and setting characteristics, but these specific metrics and their acceptance criteria are not detailed as part of this submission summary.
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Sample sized used for the test set and the data provenance: Not applicable for this type of submission as no new test set data is presented for performance evaluation against acceptance criteria. The basis for substantial equivalence is primarily the similarity in chemical composition and intended use to existing devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new ground truth establishment for a test set is discussed.
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Adjudication method: Not applicable. No new test set data or expert judgments are presented that would require an adjudication method.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is typically for diagnostic imaging devices where human interpretation is involved. Bone cement is a therapeutic/fixation device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This applies to AI/ML software. The Cemex system is a bone cement.
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The type of ground truth used: Not applicable in the context of a new performance study. The "ground truth" for a 510(k) submission like this is effectively the established safety and efficacy of the predicate devices.
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The sample size for the training set: Not applicable. This is not an AI/ML device.
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How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
In summary, the provided document describes a 510(k) submission for bone cement based on substantial equivalence, not a study evaluating a device against specific performance acceptance criteria.
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JUN 1 2 2002
Exactech, Inc. Tecres Cemex® System Bone Cement
page 1 of 2
K021715
Special 510(k) Summary of Safety and Effectiveness
| Trade Names: | Cemex ISOPLASTIC Bone CementCemex RX Bone CementCemex XL Bone Cement |
|---|---|
| Common Name: | Bone Cement |
| Classification Name: | Polymethylmethacrylate (PMMA)Bone Cement |
Legally Marketed Devices for Substantial Equivalence Comparison:
| Model | Manufacturer |
|---|---|
| Cemex System | Tecres, S.p.A. (#K000943) |
| CMW3 | CMW Laboratories(Distributed by Dow Corning Wright |
| Simplex P | Howmedica |
| Palacos R | Merck(Distributed by Smith & Nephew) |
| Dough-Type | Zimmer |
Device Description:
INTENDED USE
CEMEX RX, CEMEX ISOPLASTIC and CEMEX XL bone cements are intended to be used for the fixation of plastic and metal joint prostheses to host bone.
INDICATIONS FOR USE
CEMEX 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.
Section 4 Page 2 of 3
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Exactech, Inc. Tecres Cemex® System Bone Cement
page 2 of 2
K021715
Special 510(k) Summary of Safety and Effectiveness
CONTRAINDICATIONS
CEMEX 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 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.
GENERAL DESCRIPTION - Substantial Equivalency Information
The chemical constituents in CEMEX RX, ISOPLASTIC, and XL bone cements 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. Like the predicate CEMEX SYSTEM Bone Cement (#K000943), the ratio between the powder and liquid components of the proposed cements is 3:1.
The proportion of each ingredient in the ISOPLASTIC and RX models varies slightly from the predicate model. The XL bone cement formulation is identical to that of CEMEX SYSTEM (#K000943). The differences result in a range of viscosities to accommodate various application techniques.
Cemex XL. RX and ISO bone cements are also similar to other competitive cement products including "Simplex P" by Howmedica, "CMW 3" by Dow Corning Wright, "Dough" by Zimmer, and "Palacos R" by Smith & Nephew. Several of the predicate devices are indicated for the fixation of pathological fractures but Cemex bone cements are not indicated for this application.
PACKAGING
The liquid monomer component is contained in a trumpet shaped amber glass vial. The powder component is contained in a paper polyethylene (PE) film sachet. The product is packaged in unitary blister pack with Tyvek® lids. The outer packaging is a heavy weight cardboard box.
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.
Section 4 Page 3 of 3
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 2 2002
Ms. Lisa Simpson Regulatory Representative Exactech® 2320 NW 66th Court Gainesville, Fl 32653
Re: K021715
Trade Name: Tecres Bone Cement RX, ISOPLASTIC, XL Regulation Number: 21 CFR 888.3027 Regulation Name: PolymethyImethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: May 22, 2002 Received: May 23, 2002
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.
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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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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,
Mach N Millkern
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
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Tecres Cemex Bone Cement
Indications for Use
page iofl
ON1715 510(k) Number:
. Device Names:
Cemex Rx Bone Cement Cemex XL Bone Cement Cemex Isoplastic 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 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 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
Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | or | Over the Counter Use |
|---|---|---|
| ------------------ | ---- | ---------------------- |
for Mark A Millbern
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K021715 |
|---|---|
| Section 3Page 1 of 1 |
§ 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.”