CEMENTEK

K041493 · Teknimed, S.A. · MQV · Aug 19, 2004 · Orthopedic

Device Facts

• Record ID: K041493
• Device Name: CEMENTEK
• Applicant: Teknimed, S.A.
• Product Code: MQV · Orthopedic
• Decision Date: Aug 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cementek® is intended for use only as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Cementek® is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. The putty can be molded to specific shapes and placed into the bony voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

Device Story

Cementek is a malleable bone void filler supplied as solid and liquid phases. Mixed in the operating room by clinical staff, the components form a paste that is manually molded and placed into osseous defects. The material undergoes an athermic reaction to form an apatitic calcium phosphate cement. Once implanted, the scaffold acts as a filler that resorbs over time, facilitating replacement with natural bone during the healing process. Used in orthopedic procedures to fill non-structural bony voids.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing (physical properties) and animal model performance comparisons.

Technological Characteristics

Apatitic calcium phosphate cement. Supplied as two-part (solid/liquid) system for intraoperative mixing. Malleable paste form factor. Resorbable scaffold. Athermic setting reaction. No software or electronic components.

Indications for Use

Indicated for treatment of surgically created or traumatic osseous defects in the skeletal system (extremities, spine, pelvis) where the defect is not intrinsic to bony stability. For prescription use.

Regulatory Classification

Identification

A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.

Predicate Devices

• Cem-Ostetic™ (K022622)
• α-BSM (K011048)

Submission Summary (Full Text)

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| AUG 1 9 2004 | 510(k) S |
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| | May 20 |

Teknimed, S.A. Submitter: 11 rue Apollo 31240 L'Union FRANCE

- Contact person: J.D. Webb 1001 Oakwood Blvd Round Rock. TX 78681 512-388-0199
Cementek® Trade Name:

Common name: Bone void filler

Classification name: Class II per 21 CFR section 888.3045

Product Code: MQV

Cem-Ostetic™ (Berkley Advanced Biomaterials - K022622) Equivalent Device: α-BSM (DePuy - Κ011048).

## Device Description

As a malleable bone substitute, Cementek® is packaged as a solid phase and a liquid phase. The liquid and solid phases are mixed in the operating room, then introduced as a paste into the osseous cavity and allowed to set. This reaction is an athermic reaction resulting in a apatitic calcium phosphate cement. Cementek is marketed in two different dosages; Cementek® 20 produces 8cc of paste and Cementek® 40 produces 16cc.

## Intended Use

Cementek® is intended for use only as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Cementek® is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. The putty can be molded to specific shapes and placed into the bony voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

## Summary of Technological Characteristics Compared to Predicate Device

Cementek® is equivalent to a-BSM and Cem-Ostetic™ in terms of physical form, how supplied, compressive strength, porosity, average pore size, composition of final product and indications. In an animal model is performed similar to a-BSM.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 9 2004

Teknimed SA c/o Mr. J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd. Round Rock, TX 78681

Re: K041493

Trade Name: Cementek Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: May 28, 2004 Received: June 4, 2004

Dear Mr. Webb:

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.

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 Eederal 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 and noments as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if

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Page 2 - Mr. J.D. Webb

applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

P. 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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## Indications for Use

510(k) Number (if known): _ (04 /493

Device Name: Cementek®

Indications for Use:

Cementek® is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Cementek® is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. The putty can be molded to specific shapes and placed into the bony voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, Cementek® resorbs and is replaced with bone during the healing process.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mah A. Milburn

Restorative. and Neurological Devices

**510(k) Number** K041493