BONEOPTIMIZER

K100841 · Curasan AG · MQV · Aug 19, 2010 · Orthopedic

Device Facts

• Record ID: K100841
• Device Name: BONEOPTIMIZER
• Applicant: Curasan AG
• Product Code: MQV · Orthopedic
• Decision Date: Aug 19, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3045
• Device Class: Class 2

Intended Use

Cerasorb® MIX is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structures. It is indicated for filling of bone defects, caused by surgery, trauma or degenerative process. Cerasorb® MIX granules are intended to be gently packed into the bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, and pelvis). Cerasorb® MIX is not indicated for use in load-bearing applications. It does not possess sufficient mechanical strength, therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization. Following placement in the bony voids or gaps, the Beta-tricalcium phosphate granules are gradually resorbed and replaced with new bone.

Device Story

Cerasorb® MIX is a bone void filler composed of a 1:1 mixture of two previously cleared beta-tricalcium phosphate (beta-TCP) granule products (Cerasorb® and Cerasorb® M). The device is supplied as granules (500-2000 µm) which are mixed with autologous blood by a clinician at the point of care. The resulting paste is packed into non-load-bearing bony voids or gaps in the extremities, pelvis, or posterolateral spine. The material acts as an osteoconductive scaffold, gradually resorbing and being replaced by new bone as the patient heals. It provides no mechanical strength; therefore, surgeons must use standard internal or external fixation to ensure rigid stabilization of the site. The device is intended for prescription use only.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the identical material composition (beta-TCP) and established safety/biocompatibility profiles of the predicate devices.

Technological Characteristics

Material: ≥99% pure phase beta-tricalcium phosphate (beta-TCP). Form: Granules (500-2000 µm). Porosity: Interconnecting micro, meso, and macropores. Sterilization: Sterile, non-pyrogenic. Single patient use. Osteoconductive. Non-load-bearing.

Indications for Use

Indicated for filling bone defects (surgery, trauma, degenerative) in skeletal system voids/gaps (extremities, posterolateral spine, pelvis) not intrinsic to structural stability. Not for load-bearing applications.

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

• Cerasorb® Ortho granules (K014156)
• Cerasorb® M Ortho granules (K040216)

Submission Summary (Full Text)

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## 510(k) Summary for the Cerasorb® MIX

### 1. SUBMITTER/510(K) HOLDER

Curasan AG Lindigstrasse 4 63 801 Kleinostheim Germany

··

Dr. Wolf-Dietrich Hübner Contact Person: [phone] Telephone:

Date Prepared: August 16, 2010

## 2. DEVICE NAME

| Trade Name: | Cerasorb® MIX |
|----------------------|--------------------------------------------------------------------------|
| Common Name: | Bone Void Filler |
| Classification Name: | Filler, bone void, calcium compound, 21CFR 888.3045,<br>Product Code MQV |

## 3. PREDICATE DEVICES

.

- Cerasorb® Ortho granules subject of K014156 .
- Cerasorb® M Ortho granules subject of K040216 .

## 4. DEVICE DESCRIPTION

The Cerasorb® MIX Device is a mixture of two legally marketed bone void filler devices, the Cerasorb Ortho granules subject of K014156 and Cerasorb M Ortho granules subject of K040216. The bone replacement and bone regeneration material Cerasorb MIX consists of ≥99% pure phase beta-tricalcium phosphate (beta-TCP). The Cerasorb® and Cerasorb® M mixture includes granule sizes of 500-1000 um and 1000-2000 um. The mixing ratio is 1cc to 1cc of Cerasorb® and Cerasorb® M granules.

The material should not be packed in dry form; it should be mixed with autologous blood (blood from the void or venous blood). The implanted material must be in direct contact with the bleeding vital bone.

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## 5. INTENDED USE

Cerasorb® MIX is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structures. It is indicated for filling of bone defects, caused by surgery, trauma or degenerative process. Cerasorb® MIX granules are intended to be gently packed into the bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, and pelvis). Cerasorb® MIX is not indicated for use in load-bearing applications. It does not possess sufficient mechanical strength, therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization. Following placement in the bony voids or gaps, the Beta-tricalcium phosphate granules are gradually resorbed and replaced with new bone.

#### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

Since the Cerasorb® MIX device is a mixture of two legally marketed bone void filler devices, the Cerasorb Ortho granules subject of K014156 and Cerasorb M Ortho granules subject of K040216, the technological characteristics are identical to that described in the previously cleared 510(k) premarket notifications. The bone replacement and bone regeneration material Cerasorb® MIX consists of ≥99% pure phase beta-tricalcium phosphate (beta-TCP). The Cerasorb® and Cerasorb® M mixture includes granule sizes of 500-1000µm and 1000-2000 µm. The mixing ratiò is 1cc to 1cc. Cerasorb® and Cerasorb® M granules.

| | Cerasorb® MIX Device | Predicate Cerasorb Ortho<br>Granules | Predicate Cerasorb M Ortho<br>Granules |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Regulatory Status | Proposed | K014156 | K040216 |
| Target population | For patients with bony voids or gaps resulting from surgery, trauma or degenerative<br>processes and which are not intrinsic to the stability of the bony structure. | | |
| Labeling | Labeling contains same<br>intended use, contraindications,<br>warnings, precautions, and<br>adverse events as predicate. | same | Labeling contains same<br>intended use, contraindications,<br>warnings, precautions, and<br>adverse events as predicate. |
| Performance | Osteoconductive | Osteoconductive | Osteoconductive |
| Sizes | 500 - 2000µm | 50 - 2000µm | 50 µm -8000µm |
| Porosity | >0 to 500 µm | Micropores >0<80 µm | Interconnecting micro, meso-,<br>and macropores (0 - 500 µm) |
| Sterility | Sterile, Non-pyrogenic<br>Single patient use | Sterile, Non-pyrogenic<br>Single patient use | Sterile, Non-pyrogenic<br>Single patient use |
| Bio-compatibility | Established | Established | Established |
| Mechanical safety | Does not impart mechanical<br>strength to surgical site | Does not impart mechanical<br>strength to surgical site | Does not impart mechanical<br>strength to surgical site |

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KJOOS41

#### 7. PERFORMANCE TESTING

The only difference between the proposed device and the predicate devices is that the Cerasorb® MIX device is constructed of two forms of previously cleared calcium phosphate salts. This does not affect safety or effectiveness since they are all resorbable and carry out the same function. The safety and biocompatibility testing performed for calcium phosphates (found in K014156 and K040216) and the long history of safe clinical use. Curasan believes that the proposed device has the identical technological characteristics as the predicate devices; therefore, the Cerasorb® MIX device should behave and function exactly as the parent devices and therefore no new testing is required. Testing performed on the proposed device contained in K014156 and K040216 confirmed that the Cerasorb® MIX device meets the applicable requirements of the FDA guidance documents on bone void fillers. Therefore, the differences in material forms between the proposed and predicate devices do not impact the safety or effectiveness of the device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Curasan AG % Medical Device Consultants, Inc. Cynthia J.M. Nolte, Ph.D. Senior Regulatory Consultant 49 Plain Street North Attleboro, Massachusetts 02760

AUG 1 9 2010

Re: K100841

. Trade/Device Name: Cerasorb® MIX Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MOV Dated: July 19, 2010 Received: July 21, 2010

Dear Dr. Nolte:

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 I ( 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/CDRH0ffices/ucm115800.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Port 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K100841

# Indications for Use

510(k) Number (if known): K100841

Device Name:

Cerasorb® MIX

Indications for Use:

Cerasorb® MIX is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structures. It is indicated for filling of bone defects, caused by surgery, trauma or degenerative process. Cerasorb® MIX granules are intended to be gently packed into the bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, and pelvis). Cerasorb® MIX is not indicated for use in load-bearing applications. It does not possess sufficient mechanical strength, therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization. Following placement in the bony voids or gaps, the Beta-tricalcium phosphate granules are gradually resorbed and replaced with new bone.

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100841