CERASORB ORTHO

K014156 · Curasan AG · MQV · Mar 18, 2002 · Orthopedic

Device Facts

• Record ID: K014156
• Device Name: CERASORB ORTHO
• Applicant: Curasan AG
• Product Code: MQV · Orthopedic
• Decision Date: Mar 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cerasorb ORTHO in granular form 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 ORTHO granules are intended to be gently packed into the bony voids or gaps of the skeletal system. 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. Cerasorb ORTHO granules have no weight-bearing capacity. Therefore, osteosynthetic measures may be required. Following placement in the bony voids or gaps, the Beta-Tricalciumphosphate granules are gradually resorbed and substituted by vital, natural bone.

Device Story

Cerasorb ORTHO is a synthetic, porous, resorbable bone void filler composed of pure phase Beta-Tricalciumphosphate (β-TCP). Provided as sterile granules (500-2000 µm), it is intended for surgical use by clinicians. The device is mixed with autologous blood and packed into non-weight-bearing bony defects. It acts as an osteoconductive scaffold, guiding three-dimensional bone regeneration as the material gradually resorbs and is replaced by natural bone. It requires direct contact with bleeding vital bone to function. Because it lacks weight-bearing capacity, clinicians must use it in conjunction with osteosynthetic measures when structural stability is required. The device benefits patients by facilitating the repair of bony defects caused by trauma, surgery, or degeneration.

Clinical Evidence

Clinical evidence includes animal studies demonstrating 90% or greater resorption of the β-TCP material and clinical data showing successful resorption and bone replacement. No specific human clinical trial metrics (e.g., p-values, CIs) are provided in the summary.

Technological Characteristics

Material: Pure phase Beta-Tricalciumphosphate (ASTM F 1088-87). Form: Porous granules (500-2000 µm). Structure: Interconnected porosity. Energy: None. Connectivity: None. Sterilization: Gamma radiation. Single-use only.

Indications for Use

Indicated for filling bone voids or gaps in the skeletal system (extremities, spine, pelvis) caused by surgery, trauma, or degenerative processes in patients requiring bone void fillers. Contraindicated for use in defects intrinsic to the stability of bony structures; requires osteosynthetic support for weight-bearing.

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

• Vitoss™ Scaffold Synthetic (K014156)

Submission Summary (Full Text)

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MAR 1 8 2002

Image /page/0/Picture/1 description: The image shows the word "curasan" in a bold, sans-serif font. Above the word, there is a handwritten code "KO14156" and "10F3". The word "curasan" is the main focus of the image, and the handwritten codes appear to be annotations or identifiers.

# 510 (K) Summary Cerasorb ORTHO Synthetic Bone Void Filler

# Submitted by

Lindigstrasse 4, D - 63801 Kleinostheim, Germany curasan AG Contact person: Dr. Rolf Kaufmann, Head of Regulatory Affairs Tel.: ++49 -- 6027 -- 468653 Fax: ++49 - 6027 -- 468633 E - mail [e-mail]

CommERCIALIZATION GROUP, LLC KENNETH WEST Registered U. S. agent ECHNOLOGY SOPHIA DRIVE SAN' HILL, NC 27514 USA 116 4PEL 1.6748

Prepared:

Curasan Ab

| | Subject Device | Predicate Device |
|---------------------|-----------------------------------------------------|-----------------------------------------------------|
| Trade name | Cerasorb ORTHO | Vitoss™ Scaffold Synthetic |
| Common Name | Bone void filler | Bone void filler |
| Classification Name | Filler, β-Tricalciumphosphate<br>Preformed granules | Filler, β-Tricalciumphosphate<br>Preformed granules |

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## Comparison To Predicate Tabulated Form

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K014156
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ු ක්‍රමුණු ප්‍රධාන කොට පැහැ

| | Cerasorb ORTHO | Vitoss™ Scaffold |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Indication / intended use | Bone void filler, synthetic | Bone void filler, synthetic |
| Patient population | Patients with bone voids or<br>gaps, caused by surgery,<br>trauma or degeneration | Patients with bone voids or<br>gaps, caused by surgery or<br>trauma |
| Anatomical location | skeletal system (extremities,<br>spine, pelvis) | skeletal system (extremities,<br>spine, pelvis) |
| Labeling | Same intended use,<br>contraindications, warnings,<br>precautions and adverse<br>events as predicate | see enclosure |
| Chemical composition of the<br>material | β-Tricalciumphosphate,<br>Ca3(PO4)2 | β-Tricalciumphosphate,<br>Ca3(PO4)2 |
| Structure of the material | Interconnective porosity | Trabecular structure similar<br>to cancellous bone |
| Porosity of the material | Micropores >0<80µm | Pore size 1 - 1000 μm |
| Performance Osteoconductivity Resorption Bone remodeling Mechanical properties | +<br>+<br>+<br>Granules have no weight-<br>bearing capacity. Execution of<br>osteosynthetic measures<br>eventually necessary | +<br>+<br>Does not import mechanical<br>strength to surgical site |
| Sterility | Sterile (gamma radiation)<br>Single use only | Sterile (gamma radiation)<br>Single use only |
| Biocompatibility | Established | Established |
| Presentation | Granules, sizes:<br>500 - 1000 µm | Morsels (1-4mm sizes) and<br>blocks (9x23mm cylinder) |

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#### Device description

Cerasorb ORTHO is a porous resorbable bone void filler for the repair of bony defects. Chemically the material consists of pure phase Beta-Tricalciumphosphate, as described in the ASTM F 1088 - 87 (reapproved 1992). It is an osteoconductive implant with interconnected porosity. The implant is provided sterile in granular form, granular sizes being 500 - 1000um or 1000 - 2000 um.

When Cerasorb ORTHO is placed in the defect site with direct contact with the viable host bone, it guides the three-dimensional regeneration of bone. As the Cerasorb ORTHO granules resorbs, newly formed bone grows into the space previously occupied by the granular Beta-Tricalciumphosphate material. Cerasorb ORTHO was shown to have 90% or greater resorption in animal studies and was also shown to resorb well clinically.

### Intended use

Cerasorb ORTHO in granular form is intended for use as a bone vold 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 ORTHO granules are intended to be gently packed into the bony voids or gaps of the skeletal system. 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.

Cerasorb ORTHO granules have no weight-bearing capacity. Therefore, osteosynthetic measures may be required.

Following placement in the bony voids or gaps, the Beta-Tricalciumphosphate granules are gradually resorbed and substituted by vital, natural bone.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right and has a sleek, modern design. The text is in a simple, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 8 2002

Curasan AG c/o Arrowsmith-Lowe Consulting, Inc. 5 Eagle Creek Road P.O. Box 3148 Ruidoso, New Mexico 88355 Attn: Thomas Arrowsmith-Lowe

Re: K014156

Cerasorb ORTHO Regulatory Class: unclassified Product Code: MQV Dated: December 18, 2001 Received: December 19, 2001

Dear Dr. Arrowsmith-Lowe:

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

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Page 2 - Dr. Thomas Arrowsmith-Lowe:

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 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 Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Mark N Wilkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices

Enclosure

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Page 1 of I

510(k) Number (if known): K014156

Cerasorb ORTHO Device Name:

Indications For Use: Intended use

Cerasorb ORTHO in granular form is intended for use as a bone void filler for volds 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 ORTHO many of wou intended to be gently packed into the bony voids or gaps of the skeletal system. 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.

Cerasorb ORTHO granules have no weight-bearing capacity. Therefore, osteosynthetic measures may be required.

Following placement in the bony voids or gaps, the Beta-Tricalciumphosphate granules are gradually resorbed and replaced with new bone.

(PLEASE DO NOT WRITE BELOW THIS LINE-CCONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of CDevice Evaluation (ODE)

for Mark A. Millman

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

510(k) Number -

(Optional Format 3-10-98)