K Number

Device Name

Manufacturer

EXACTECH, INC.

Date Cleared

2003-05-22

(16 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended 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.

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.

AI/ML Overview

This submission describes the "Exactech, Inc. Tecres Cemex® System Fast Bone Cement" and compares it to a predicate device, "Cemex System" (K000943). The primary difference is a change in the powder-to-liquid ratio, leading to a quicker setting time.

There is no study described in this document that proves acceptance criteria for device performance beyond direct comparison to the predicate device based on material composition and intended use. This is a 510(k) submission for a Class II medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical performance studies or establishing new acceptance criteria for efficacy. The details provided primarily focus on the device description, packaging, mixing/application, and sterilization, along with a statement of substantial equivalence to a predicate.

Therefore, many of the requested elements for a study proving device performance against acceptance criteria are not explicitly present in the provided document.

Here's an attempt to address the request based on the information available:

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence claim for a bone cement, the "acceptance criteria" revolve around the composition and intended function being nearly identical to the predicate, with the only notable performance difference being the setting time.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Cemex System Fast)
Intended Use: Fixation of plastic/metal joint prostheses to host bone.	Identical to Cemex System.
Indications for Use: Same orthopedic musculoskeletal procedures.	Identical to Cemex System.
Contraindications: Same conditions.	Identical to Cemex System.
Chemical Constituents: Identical to predicate.	Identical: Methylmethacrylate, N-N dimethyl p-toluidine, hydroquinone (liquid); Polymethylmethacrylate, barium sulphate, benzoyl peroxide (powder).
Sterility Assurance Level (SAL): Meets standards.	Powder: 10^-6 (EO); Liquid: 10^-3 (membrane filtration). (Implied to meet standards based on predicate equivalence).
Packaging: Identical to predicate.	Uses identical double blister pack with Tyvek® lids and heavy weight cardboard box.
Mixing & Application: Manual closed mixing, syringe application.	Same method, with transparency for inspection as per ISO 5833.
Powder-to-Liquid Ratio: Specific ratio for faster setting.	2.4:1 (compared to 2.7:1 for predicate). This is the key distinguishing "performance" aspect.
Setting Time: Quicker than predicate.	Quicker due to reduced powder-to-liquid ratio (specific time not quantified in this document, but stated as the reason for the change).

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable. No "test set" in the sense of a clinical or in-vitro performance study with a specific sample size is detailed in this document. Substantial equivalence is often based on material characterization and comparison to predicate device specifications.
Data Provenance: Not applicable for a separate "test set." The substantial equivalence claim is based on the known characteristics and regulatory history of the predicate device (Cemex System, K000943).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. Ground truth in this context is established by regulatory bodies and standards for bone cements, and by the manufacturer's internal product specifications and chemical analysis, not by a panel of external experts evaluating a "test set."
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable. There is no "adjudication method" described for a test set in this document, as the submission relies on demonstrating intrinsic material properties and design similarity to a predicate.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: Not applicable. This device is a bone cement, not an AI-powered diagnostic or decision support tool that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This is a physical bone cement, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: The "ground truth" for this submission is the established regulatory acceptance and performance of the legally marketed predicate device (Cemex System, K000943). For the new device, the ground truth is established through its chemical composition matching the predicate and the design change (powder-to-liquid ratio) leading to a specific, understood physical property modification (quicker setting time), which is presented as an accommodation for various application techniques rather than a new primary therapeutic effect. Basic material characterization (e.g., setting time, mechanical properties if tested) would form part of the technical information provided for such a change, although not detailed in this summary.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that uses training sets.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable. This is not an AI/machine learning device.

Summary

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K031430

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

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

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Exactech, Inc. Tecres Cemex® System Fast Bone Cement

Special 510(k) Summary of Safety and Effectiveness

GENERAL DESCRIPTION -- Substantial Equivalency Information

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.

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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.

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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. 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,

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

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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

K031430

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

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Over the Counter Use

Section 3 Page 1 of 1

Regulation Number and Section

§ 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.”