OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221 901, OSSAPLAST ORTHO, 3.0ML, MODEL# 221 903

K042305 · Ossacur AG · MQV · Oct 21, 2004 · Orthopedic

Device Facts

• Record ID: K042305
• Device Name: OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221 901, OSSAPLAST ORTHO, 3.0ML, MODEL# 221 903
• Applicant: Ossacur AG
• Product Code: MQV · Orthopedic
• Decision Date: Oct 21, 2004
• 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, illum, 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 device.

Device Story

OSSAPLAST ORTHO is a synthetic, implantable, resorbable, radiopaque bone void filler composed of pure-phase beta-tricalcium phosphate (β-TCP) in granulate form (500-1000 µm). It is osteoconductive with high interconnecting porosity. The device is supplied sterile in glass vials within Tyvek pouches. It is intended for surgical use by physicians to fill non-structural osseous defects in the spine, pelvis, ilium, or extremities. Once implanted, the material is gradually resorbed and replaced by natural bone during the healing process, aiding in defect repair.

Clinical Evidence

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

Technological Characteristics

Material: pure-phase β-TCP [Ca3(PO4)2]; Form: granulate (500-1000 µm); Porosity: high interconnecting; Radiopaque; Conforms to ASTM F1088-04; Sterilization: sterile configuration.

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 filling.

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)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the text "K042305" at the top, followed by the word "OSSACUR" in a stylized font. The word "OSSACUR" is enclosed within two curved lines, one above and one below, forming a circular shape around the word. The text and graphic appear to be part of a logo or branding element.

OCT 2 1 2004

# 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: | August 23, 2004 |

- B. Device Name

| Trade Name: | OSSAPLAST™ ORTHO |
|----------------------|----------------------------------------------------------------------------------|
| Common/Usual Name: | Bone Void Filler |
| Classification Name: | Resorbable calcium salt bone void filler device<br>§888.3045 (Product Code: MQV) |

- C. Predicate Device
Trade Name:

Cerasorb® ORTHO (K014156)

## D. Device Description

OSSAPLAST ORTHO is a synthetic, implantable, resorbable, radiopaque ß-tricalcium phosphate (β-ΤCP) ceramic in granulate form (particle size of 500 - 1000 µm). It consists of pure-phase ß-TCP [Ca3(PO4)2] and is osteoconductive, with high interconnecting porosity.

OSSAPLAST ORTHO is supplied sterile in sealed glass vials in various quantities. Each vial is packaged inside a Tyvek pouch to assure a double sterile configuration.

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### E. Intended Use

OSSAPLAST ORTHO is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, illum, 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 device.

## F. Technological Characteristics Summary

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

## 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 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 device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes on its body, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 1 2004

Ossacur AG c/o Ms. Kristi M. Kistner, RAC President Pacific OtterWorks, Inc. 975 Veronica Springs Road Santa Barbara, CA 93105

Re: K042305

OSSAPLAST® ORTHO Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MQV Dated: August 23, 2004 Received: August 25, 2004

Dear Ms. Kistner:

We have reviewed your Section 510(k) premarket notification of intent to market the we have feviewed your bootion o re(s) pinned the device is substantially equivalent (for device for use stated in the enclosure) to legally marketed predicate devices the indications for abo subscription to May 28, 1976, the enactment date of the marketed in morisiate commits, 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 with the provisions of the Pecial a pplication (PMA). You may, therefore, market the approval of a promance apple on well provisions of the Act. The general controls device, subject to the general requirements for annual registration, listing of devices, provisions of the ing 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 (I MF), It may be babyer to saving in the Code of Federal Regulations, Title 21, Parts affecting your de ross on 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 r lease be advised anas made a determination that your device complies with other not mean that I Drivinar of I mac or any Federal statutes and regulations administered by other requirements on the Her of at comply with all the Act's requirements, including, but not I cadelar agencies: " on and listing (21 CFR Part 807); labeling (21 CFR Part 801); good

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## Page 2 - Ms. Kristi M. Kistner, RAC

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.

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 A. Milkers

Celia M. Witten, Ph.D., M.D. 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): 1042305

Device Name: OSSAPLAST® ORTHO Bone Void Filler

Indications for Use:

OSSAPLAST ORTHO is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, 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.

Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (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)

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Mark A. Millham

Division of General, Restorative, and Neurological Devices

510(k) Number K042305