OSSAPLAST ORTHO

K050416 · Ossacur AG · MQV · Mar 29, 2005 · Orthopedic

Device Facts

• Record ID: K050416
• Device Name: OSSAPLAST ORTHO
• Applicant: Ossacur AG
• Product Code: MQV · Orthopedic
• Decision Date: Mar 29, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OSSAPLAST ORTHO is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, illium, and/or extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone or a degenerative process. OSSAPLAST ORTHO is gradually resorbed and replaced with bone during the healing process.

Device Story

OSSAPLAST ORTHO is a synthetic, radiopaque, resorbable bone void filler composed of pure-phase β-tricalcium phosphate (β-TCP) in granulate form (1000–2000 µm). It features high interconnecting porosity to facilitate osteoconduction. The device is supplied sterile in glass vials within Tyvek pouches. It is intended for surgical use by clinicians to fill non-structural osseous defects. Upon implantation, the material is gradually resorbed and replaced by natural bone during the healing process, aiding in the repair of skeletal voids.

Clinical Evidence

Bench testing only. Performance testing conducted in conformance with Class II Special Controls Guidance Document for Resorbable Calcium Salt Bone Void Filler Devices.

Technological Characteristics

Material: pure-phase β-tricalcium phosphate (β-TCP). Conforms to ASTM F1088-04. Form: granulate (1000–2000 µm). Properties: radiopaque, osteoconductive, high interconnecting porosity. Sterilization: sterile.

Indications for Use

Indicated for filling non-structural bony voids or gaps in the skeletal system (spine, pelvis, ilium, extremities) caused by surgery, trauma, or degenerative processes in patients requiring bone void fillers.

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 (K014156)
• Cerasorb® M ORTHO (K040216)
• OSSAPLAST™ ORTHO (K042305)

Submission Summary (Full Text)

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K05 0416

MAR 2 9 2005

Image /page/0/Picture/2 description: The image shows the word "OSSACUR" in a bold, sans-serif font. A thick, black circle partially surrounds the word, with the top and bottom portions of the circle missing. The word is centered within the circle, creating a logo-like appearance.

# 510(K) Summary

#### A. Submitter Information

| Submitter's Name: | OSSACUR® AG |
|----------------------|-----------------------|
| Address: | Benzstrasse 2 |
| | D-71720 |
| | Oberstenfeld, Germany |
| Phone Number: | ([phone] |
| Fax Number: | ([phone] |
| Contact Person: | Arne Briest |
| Date of Preparation: | February 16, 2005 |

B. Device Name

| Trade Name: | OSSAPLAST ™ ORTHO (1000 – 2000 μm) |
|----------------------|-------------------------------------------------|
| Common/Usual Name: | Bone Void Filler |
| Classification Name: | Resorbable calcium salt bone void filler device |
| | §888.3045 (Product Code: MOV) |

### C. Predicate Devices

| Trade Name: | Cerasorb® ORTHO (K014156) |
|-------------|-----------------------------|
| Trade Name: | Cerasorb® M ORTHO (K040216) |
| Trade Name: | OSSAPLAST™ ORTHO (K042305) |

### D. Device Description

OSSAPLAST ORTHO (1000 – 2000 µm) is a synthetic, implantable, resorbable, radiopaque β-tricalcium phosphate (β-ΤCP) ceramic in granulate form. It consists of pure-phase β-ΤСР [Саз(РОд)չ] and is osteoconductive, with high interconnecting porosity.

# 000061

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K050416

Image /page/1/Picture/1 description: The image shows the number "2/2" in the upper left corner. To the right of the numbers is the logo for "OSSACUR". The logo has the text "OSSACUR" with a partial circle above and below the text.

OSSAPLAST ORTHO (1000 – 2000 µm) is supplied sterile in sealed glass vials, in various quantities. Each vial is packaged inside a Tyvek pouch to assure a double sterile configuration.

#### E. Intended Use

OSSAPLAST ORTHO is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, illium, and/or extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone or a degenerative process. OSSAPLAST ORTHO is gradually resorbed and replaced with bone during the healing process. OSSAPLAST ORTHO is substantially equivalent in intended use to the predicate devices.

#### F. Technological Characteristics Summary

OSSAPLAST ORTHO (1000 -- 2000 µm) does not incorporate any new technological characteristics as compared to the predicate devices. OSSAPLAST ORTHO (1000 - 2000 um) and the predicate devices are made from the same material (pure-phase β-TCP) and conform to the standard specifications of ASTM F1088-04 for a medical grade ß-TCP to be used in surgical implant applications. OSSAPLAST ORTHO (1000 - 2000 µm) is substantially equivalent to the predicate devices in regard to structure, porosity, form, packaging, sterility, and biocompatibility.

#### G. Performance Data

Performance testing was conducted in conformance with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA (FDA/ODE, 6/2/2003). All data demonstrated that OSSAPLAST ORTHO (1000 – 2000 µm) is suitable for use as a bone void filler. It has been designed and manufactured to perform in a manner substantially equivalent to that of the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized waves or lines, often interpreted as representing the department's mission related to health and well-being.

#### Public Health Service

MAR 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kristi M. Kistner, RAC President OSSACUR AG C/o Pacific Otter Works, Inc. 975 Veronica Springs Road Santa Barbara, California 93105

Re: K050416

K050410
Trade/Device Name: OSSAPLAST™ ORTHO (1000 TO 2000 microns) 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: February 16, 2005 Received: February 18, 2005

Dear Ms. Kistner:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conninered phor to may 20, 2017 () in accordance with the provisions of the Federal Food, Drug, de Mees that have been that do not require approval of a premarket approval application (PMA). and Cosmotion For (110) and the device, subject to the general controls provisions of the Act. The r ou may, ateres, anians of the Act include requirements for annual registration, listing of general controls profice, 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 that I Dr Has Intactions and regulations administered by other Federal agencies. You must or any I 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 form in the quant) of ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Ms. Kristi M. Kistner

This letter will allow you to begin marketing your device as described in your Section 510(k)
The success of the success of a lot sticket to the legice of your device to a le This letter will allow you to begin makemity of substantial equivalence of your device to a legally premarket notification. THE FDA Inding of substantal equive 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 if you desire specific advice for your device of a Also, please note the regulation entitled, contact the Office of Comphanes at (210) 216-78 Part 807.97). You may obtain " Misbranding by reference to premainers within and r the Act from the Division of Small other general information on your responses Assistance at its toll-free number [phone] or and index html Manufacturers, International and Oolisanters http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Hypt Rhodes

Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# SECTION I-E.

## Statement of Indications for Use

510(k) Number (if known): _ |<o5o416

Device Name: OSSAPLAST™ ORTHO (1000 to 2000 um) Bone Void Filler

### Indications for Use:

mateations for Coo.
OSSAPLAST ORTHO is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, illium, and/or extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically immolo to the other or osseous defects resulting from traumatic injury to the broated observerative process. OSSAPLAST ORTHO is gradually resorbed and replaced with 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)

Atwell Rhodes

Division of General, Restorative, and Neurological Devices

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OSSACUR® AG

KOSTAL B 510(k) Number-

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000016