3I CALCIUM SULFATE BONE CEMENT

K012047 · Implant Innovations, Inc. · LYC · Sep 19, 2001 · Dental

Device Facts

• Record ID: K012047
• Device Name: 3I CALCIUM SULFATE BONE CEMENT
• Applicant: Implant Innovations, Inc.
• Product Code: LYC · Dental
• Decision Date: Sep 19, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

3i® Calcium Sulfate Bone Cement is used over a filled defect providing a stable barrier to graft material migration and is also indicated for use as a binder of bone graft particles. For use in dental applications only.

Device Story

3i Calcium Sulfate Bone Cement is a two-component system consisting of calcium sulfate dihydrate powder and a liquid solution (potassium citrate monohydrate, sodium phosphate dibasic, and distilled water). Components are mixed via a female-female Luer coupler to form a homogenous paste. The paste is applied by a dental clinician to a bone defect site; it hardens within 5-10 minutes. The device functions as a physical barrier to prevent graft migration and as a binder for bone graft particles. It is biodegradable and resorbs in approximately four to eight weeks. The device provides a stable environment for bone healing in dental procedures.

Clinical Evidence

No clinical testing performed. Safety and efficacy supported by biocompatibility testing (non-toxic, non-mutagenic, non-hemolytic, non-pyrogenic) and animal studies demonstrating biodegradation/resorption in four to eight weeks.

Technological Characteristics

Material: Calcium sulfate dihydrate powder; liquid component: potassium citrate monohydrate, sodium phosphate dibasic, distilled water. Form factor: Two-syringe system with Luer coupler for mixing. Hardening time: 5-10 minutes. Biodegradable. No software or electronic components.

Indications for Use

Indicated for dental applications as a barrier to prevent graft material migration over filled defects and as a binder for bone graft particles.

Regulatory Classification

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• CAPSET® Calcium Sulfate Bone Graft Plaster

Submission Summary (Full Text)

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## SEP 1 9 2001

# KOIZ

### Summary of Safety and Effectiveness

Applicant/Sponsor: Biomet, Inc. 56 E. Bell Drive Warsaw, Indiana 46582

- Contact Person: Mary L. Verstynen Telephone: [phone] Fax: [phone]
Proprietary Name: 3i® Calcium Sulfate Bone Cement

Common Name: calcium sulfate dihydrate

Classification Name: Implant, endosseous for bone filling and/or reconstruction (872.3640)

Legally Marketed Device To Which Substantial Equivalence Is Claimed: CAPSET® Calcium Sulfate Bone Graft Plaster

Device Description: 318 Calcium Sulfate Cement is packaged in two syringes. One svringe contains the powder component while the other syringe contains the liguid component. The powder component is calcium sulfate dihydrate (CaSO4 · 2H2O). The liquid component is a solution comprised of potassium citrate monohydrate (KaC6HsOr " H2O), sodium phosphate dibasic (NazHPO4 7H2O), and distilled water (H2O). The svringe with the liguid component comes with a female-female Luer coupler for connecting the two syringes together for mixing. When mixed, the powder and liquid combine to form a homogenous paste. The paste hardens approximately 5-10 minutes after the start of mixing.

Intended Use: 3i® Calcium Sulfate Bone Cement is used over a filled defect providing a stable barrier to graft material migration and is also indicated for use as a binder of bone graft particles.

Summary of Technologies: The cement has the same technological characteristics as the predicate device

Non-Clinical Testing: 38 Calcium Sulfate Cement is biodegradable and in animal studies, depending on the defect size, was found to resorb in approximately four to eight weeks. Biocompatibilty testing and animal studies demonstrate the safety of the material, which was found to be non-toxic, non-mutagenic, non-hemolytic, and nonpyrogenic.

Clinical Testing: Not performed on this device,

## 00259

³i is a registered trademark of Implants Innovations, Inc. Capset is a registered trademark of Lifecore Biomedical, Inc.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a human figure in profile, with three overlapping silhouettes suggesting a sense of community or interconnectedness.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 9 2001

Implant Innovations, Incorporated C/O Ms. Mary L. Verstynen Biomet. Incorporated 56 East Bell Drive Warsaw, India 46582

Re: K012047

Trade/Device Name: 31 Calcium Sulfate Bone Cement Regulation Number: None Regulation Name: Calcium Ulfate Dihydrate Regulatory Class: Unclassified Product Code: LYC Dated: June 22, 2001 Received: June 29, 2001

Dear Ms. Verstynen:

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 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

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Page 2 - Ms. Verstynen

and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and insting (21 er read on the quality systems (QS) regulation (21 CFR Part 820); and if roquirelier as as betronic product radiation control provisions (section 531-542 of the Act; 21); CFR 1000-1050.

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 premilated 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours,

L. Alatorre

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K012047

Page of

510(k) NUMBER (IF KNOWN): ___K012047

DEVICE NAME: 3i® Calcium Sulfate Bone Cement

INDICATIONS FOR USE:

3i® 's Calcium Sulfate Bone Cement is used over a filled defect providing a stable barrier to graft material migration and is also indicated for use as a binder of bone graft particles.

For use in dental applications only.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use (Optional Format 1-2-96)

Susan Pharr

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ COLORY