CERASORB M ORTHO

K040216 · Curasan AG · MQV · Mar 26, 2004 · Orthopedic

Device Facts

• Record ID: K040216
• Device Name: CERASORB M ORTHO
• Applicant: Curasan AG
• Product Code: MQV · Orthopedic
• Decision Date: Mar 26, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cerasorb® M ORTHO (morsels) is intended for use as a bone void filler in voids or gaps (resulting from surgery, trauma or degenerative processes) in the skeletal system (extremities, spine, pelvis) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the ß-TCP ceramic material is gradually resorbed and replaced with bone. The placement of Cerasorb® M ORTHO should not be in dry form, the material should be mixed with autologous blood.

Device Story

Cerasorb® M ORTHO is a synthetic, porous, resorbable bone void filler composed of pure phase Beta-Tricalcium Phosphate (ß-TCP). It serves as a line extension to existing granular and block forms of Cerasorb® ORTHO. The device is provided as polygonal morsels with interconnecting microporosity and meso/macropores (50-500 µm). During orthopedic or trauma surgery, the clinician mixes the morsels with autologous blood and packs the mixture into non-load-bearing skeletal voids or gaps. The material acts as an osteoconductive scaffold, gradually resorbing and being replaced by natural bone over time. It is intended for use in the extremities, spine, and pelvis.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and material composition.

Technological Characteristics

Material: Pure phase Beta-Tricalcium Phosphate (ß-TCP) per ASTM F 1088-87. Structure: Polygonal morsels with interconnecting microporosity and meso/macropores (50-500 µm). Function: Osteoconductive, resorbable bone void filler. Form factor: Granular/morselized solid.

Indications for Use

Indicated for use as a bone void filler in skeletal voids or gaps (extremities, spine, pelvis) resulting from surgery, trauma, or degenerative processes that are not intrinsic to bony stability. Contraindicated for use in dry form; must be mixed with autologous blood.

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 (granular form)
• Cerasorb® ORTHO (block forms)
• Vitoss Scaffold Synthetic

Submission Summary (Full Text)

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March 12, 2004

MAR 2 6 2004

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# Special 510 (K) Summary: Line Extension to Cerasorb® ORTHO (granular form)

### Submission Information:

| Name and Address<br>of the Sponsor: | curasan AG<br>Lindigstrasse 4<br>63801 Kleinostheim<br>Germany |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Stefan Meiners<br>Head of Regulatory Affairs and Quality Management<br>Tel.: ++49 - 6027 - 4686-94<br>Fax: ++49 - 6027 - 4686-33<br>E - Mail: [e-mail] |
| Registered U. S. agent: | Dr. Eric Wiechert<br>109 Shore Drive<br>Garner, NC 27529<br>USA<br>Phone: 919 - 772-8518, fax: 919 - 772-1300<br>E - Mail: [e-mail] |

### Device Identification:

| Proprietary Name: | Cerasorb® M ORTHO |
|-------------------|-------------------|
| Common Name: | Bone Void Filler |
| Classification: | Class II |

# Predicate Devices:

| | Cerasorb® ORTHO (granular form): Bone void filler consisting of pure phase<br>Beta-Tricalcium Phosphate. |
|----------------------------|--------------------------------------------------------------------------------------------------------------------|
| | Cerasorb® ORTHO (block forms): Bone void filler, block forms consisting of pure<br>phase Beta-Tricalcium Phosphate |
| Vitoss Scaffold Synthetic: | Bone void filler, granules, block forms and morsels<br>consisting of Beta-Tricalcium Phosphate |

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## Description of the Device Modification:

The device modification is a change in the shape resp. size of the bone void filler. The predicate device Cerasorb® ORTHO, a synthetic, porous, resorbable and osteoconductive bone void filler, was developed in granular form (spherical granules) of different diameter (500-1000um, 1000-2000um) to be filled in the bone void(s). The material consists of pure phase Beta-Tricalcium Phosphate of interconnecting porosity.

This submission is intended to address a modification in the shape of the bone void filler. The bone void filler is now additionally presented as polygonal shaped morsels of different sizes ranging from 50 8000m. The pure phase Beta-Tricalcium Phosphate material is of interconnecting microporosity and additionally contains defined interconnecting meso-, and macropores (50 - 500 um).

## Intended Use:

Cerasorb® M ORTHO (morsels) is intended for use as a bone void filler in voids or gaps (resulting from surgery, trauma or degenerative processes) in the skeletal system (extremities, spine, pelvis) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the ß-TCP ceramic material is gradually resorbed and replaced with bone. The placement of Cerasorb® M ORTHO should not be in dry form, the material should be mixed with autologous blood.

## Statement of technological comparison

All design modifications consist of pure phase Beta-Tricalcium Phosphate ceramic material according to ASTM F 1088-87, reapp. 1992. The material is of interconnecting porosity, osteoconductive and resorbable.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 2004

Curasan AG C/o Eric Wiechert, Ph.D., RAC President Applications Specialists International, Inc. 109 Shore Drive Garner. North Carolina 27529

Re: K040216

Trade/Device Name: Cerasorb® M ORTHO Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: II Product Code: MQV Dated: March 12, 2004 Received: March 18, 2004

Dear Dr. Wiechert:

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 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 - Eric Wiechert, Ph.D., RAC

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 yours,

Sincerely yours,

Mark N Milkman

Celia M. Witten, PhD. MD 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): K040216

Cerasorb® M ORTHO Device Name:

Indications for Use:

Cerasorb® M ORTHO (polygonal broken morsels) is intended for use as a bone void filler in voids or gaps (resulting from surgery, trauma or degenerative processes) in the skeletal system (e.g. extremities, spine, pelvis) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the ß-TCP ceramic material is gradually resorbed and replaced with bone. The placement of Cerasorb® M ORTHO should not be in dry form, the material should be mixed with autologous blood.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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510(k) Number кон 0216