CERAMENT BONE VOID FILLER

K051951 · Bonesupport AB · MQV · Sep 28, 2005 · Orthopedic

Device Facts

• Record ID: K051951
• Device Name: CERAMENT BONE VOID FILLER
• Applicant: Bonesupport AB
• Product Code: MQV · Orthopedic
• Decision Date: Sep 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cerament™ is a ceramic bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Cerament™ is indicated to be injected into bony voids or gaps in the skeletal system, i.e. extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects from traumatic injury to the bone. Cerament™ provides a bone void filler that resorbs and is replaced by bone during the healing process.

Device Story

Cerament™ is an injectable bone mineral substitute for filling non-structural orthopedic bone voids. Material consists of powder (calcium sulphate hemihydrate and hydroxyapatite) and liquid (radio-contrast agent Iohexol). Components are mixed into a viscous paste and injected percutaneously into bone voids using an accompanying device. Procedure performed under radiographic guidance to monitor filling. Material resorbs over time, with hydroxyapatite providing an osteoconductive scaffold for new bone in-growth. Used by orthopedic surgeons in clinical settings. Benefits include providing a resorbable filler that is gradually replaced by natural bone during the healing process.

Clinical Evidence

No clinical data provided. Evidence consists of extensive in vitro and animal testing demonstrating that the device meets requirements for calcium salt bone void fillers.

Technological Characteristics

Injectable bone mineral substitute composed of calcium sulphate hemihydrate, hydroxyapatite, and Iohexol (radio-contrast agent). Material is a two-component system (powder/liquid) mixed prior to percutaneous injection. Osteoconductive properties; resorbable. No electronic components or software.

Indications for Use

Indicated for orthopedic patients with bony voids or gaps in the skeletal system (extremities, spine, pelvis) resulting from surgical procedures or traumatic injury, where the void is not intrinsic to bony structure stability.

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

• MIIG IITM (K024336)
• Osteoset BVF Kit (K010532)
• Cem-OsteticTM (K022622)
• Norian® XR (K023862)
• ApaPore® (K033722)
• Hapset (K961511)

Submission Summary (Full Text)

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# SECTION III.

## PRE-510(K) SUMMARY

| SUBMITTER: | Bone Support AB<br>Ideon Science Park<br>Ole Romesrv 12<br>SE-223 Lund Sweden |
|----------------------|-------------------------------------------------------------------------------|
| DATE PREPARED: | September 21st, 2005 |
| TRADE NAME: | Bone Support AB Cerament™ - |
| CLASSIFICATION NAME: | Filler, Bone Void MQV<br>Class II Special Controls per<br>21 CFR 8883045 |

## PREDICATE DEVICES:

| 510(k) Number | Trade or Proprietary or Model Name | Manufacturer |
|---------------|------------------------------------|-------------------------------|
| K024336 | MIIG IITM | Wright Medical Technology |
| K010532 | Osteoset BVF Kit | Wright Medical Technology |
| K022622 | Cem-OsteticTM | Berkley Advanced Biomaterials |
| K023862 | Norian® XR | Synthes Inc. |
| K033722 | ApaPore® | Apa Tech Limited |
| K961511 | Hapset | Lifecore Biomedical |

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#### Device Description:

Cerament™ is an injectable bone mineral substitute material intended for stabilization of fractured osteoporotic bone void. The material consists of a powder and a liquid component. The major constituents of the powder component are calcium sulphate hemihydrate and hydroxyl apatite and the liquid component is the radio-contrast agent Iohexol. Mixing of the powder and liquid components results in a viscous mixture suitable for percutaneous injection into the fractured bone void. During resorption of the calcium sulfate dihydrate, the hydroxy apatite remains intact providing osteoconductive support for the in-growth of new bone, which gradually replaces the resorbed calcium sulfate dihydrate.

The bone mineral substitute material is injected into the bone void in a percutaneous procedure with the use of an accompanying injection device. Prior to injection, the powder and liquid components of the substitute material are mixed in a mixing container. The substitute material is injected into the bone void during careful radiographic inspection until the bone void is filled as judged from the radiographic image.

#### Intended Use:

#### Bone Support AB Cerament™ - - Indications:

Cerament™ is a ceramic bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Cerament™ is indicated to be injected into bony voids or gaps in the skeletal system, i.e. extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects from traumatic injury to the bone. Cerament™ provides a bone void filler that resorbs and is replaced by bone during the healing process.

#### Technological Characteristics and Substantial Equivalence

Cerament™ is composed of a calcium salt and hydroxyapatite equivalent to that contained in a number of the predicate devices and to that in routine clinical use. The technologies employed in Cerament™ and in its predicate devices is therefore substantially equivalent. Cerament™ is presented in the same manner as its predicate devices. Its indications, contraindications, risks and potential adverse events are the same and thus substantial equivalence is claimed for this device.

#### Testing

Extensive in vitro and animal testing has shown Cerament™ to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a traditional symbol of medicine. The symbol is composed of three curved lines that represent the human form.

SEP 2 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bone Support AB c/o Jefferey R. Shideman, Ph.D. President International Medical Products Corporation 7307 Glouchester Drive Edina, Minnesota 55435

Re: K051951

Trade/Device Name: Cerament Bone" Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: July 8, 2005 Received: July 22, 2005

Dear Dr. Shideman:

We have reviewed your Scction 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 docs not mean that FDA has made a determination that your device complics 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 - Jefferey R. Shideman, Ph.D.

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/cdrb/industry/support/index.html.

Sincerely yours,

Mark McMillan

Mark N. Melkerson, Acting 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): K051951

Device Name: Cerament Bone™ Void Filler

Indications for Usc:

Cerament™ is a ceramic bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Ccrament™ is indicated to be injected into bony voids or gaps in the skeletal system, i.c. extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects from traumatic injury to the bone. Cerament™ provides a bone void filler that resorbs and is replaced by bone during the healing process

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

(Posted November 13, 2003)

Mark A. Williamson
Page *_ of _*

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number**