OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER

K050490 · Medicrea · MQV · Apr 11, 2005 · Orthopedic

Device Facts

• Record ID: K050490
• Device Name: OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER
• Applicant: Medicrea
• Product Code: MQV · Orthopedic
• Decision Date: Apr 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OSMOSYS is intended for use as a bone void filler to fill bony void gaps of the skeletal system (i.e. the extremities, spine and pelvis) resulting from surgery or trauma that are not intrinsic to the stability of the bony structure. OSMOSYS is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. Following placement in the bony voids or gap, OSMOSYS resorbs and is replaced with bone during the healing process.

Device Story

OSMOSYS is a synthetic, biphasic, macro-porous bio-ceramic bone void filler composed of hydroxyapatite (HA) and tricalcium phosphate (TCP). Available as irregular granules (2-3 mm) or sticks (5x5x20 mm), it is implanted by surgeons into bony voids or gaps in the extremities, spine, or pelvis resulting from surgery or trauma. The material features a porous structure (average 70% volume, 300-500μm pore size) that facilitates resorption and replacement with natural bone during the healing process. It is intended for non-load-bearing applications where the defect does not compromise skeletal stability.

Clinical Evidence

Bench testing only. Evidence consists of material characterization, including pycnometry for porosity analysis and optic microscopy for pore size verification, confirming compliance with ASTM F1088-1987 and ASTM F1185-2003 standards.

Technological Characteristics

Biphasic calcium phosphate ceramic (hydroxyapatite and tricalcium phosphate). Macro-porous structure (70% porosity, 300-500μm pore size). Form factors: 2-3 mm granules and 5x5x20 mm sticks. Conforms to ASTM F1088-1987 and ASTM F1185-2003.

Indications for Use

Indicated for patients requiring treatment of surgically created osseous defects or traumatic bone injuries in the extremities, spine, and pelvis. Not for use in defects intrinsic to bony structure stability.

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

• Calcigen (K030178)
• Mastergraft Resorbable Ceramic (K020986)

Submission Summary (Full Text)

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## OSMOSYS Bone Substitute 510(k) Summarv April 4, 2005

| <b>Submitter</b> | MEDICREA TECHNOLOGIES<br>ZI Chef de Baie<br>17000 La Rochelle<br>France |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| <b>Contact person</b> | J.D. Webb<br>1001 Oakwood Blvd<br>Round Rock. TX 78681<br>512-388-0199 |
| <b>Trade Name</b> | OSMOSYS Calcium Phosphate Ceramic Bone Filler |
| <b>Common name</b> | Bone void filler |
| <b>Classification name</b> | Filler, calcium sulfate, preformed pellets<br>Class II per 21 CFR section 888.3045 |
| <b>Product Code</b> | MQV |
| <b>Equivalent Device</b> | Calcigen (K030178) (Biomet - Warsaw, IN)<br>Mastergraft Resorbable Ceramic (K020986) (Medtronic Sofamor Danek -<br>Memphis, TN). |
| <b>Device Description</b> | |

OSMOSYS is a synthetic bone substitute composed of a mixture of hydroxyapatic (HA) and tricalcium phosphate (TCP). The resulting product is a biphasic macro-porous bio-ceramic designed to fill bony void gaps of the skeletal system (i.e., the extremities, spine and polvis) resulting from surgery or trauma that are not intrinsic to the stability of the bony structure.

Analysis by pycnometry reveals the presence of pores representing on average 70% of the volume of the material. The pores are between 300um and 500μm, correlating well with the values from optic microscopy. OSMOSYS is available in the form of irregular granules (2-3 mm) and sticks (5x5x20 mm).

OSMOSYS is in conformity with the specifications of ASTM F1088-1987 and ASTM F1185-2003.

## Intended Use

OSMOSYS is intended for use as a bone void filler to fill bony void gaps of the skeletal system (i.e. the extremities, spine and pelvis) resulting from surgery or trauma that are not intrinsic to the stability of the bony structure. OSMOSYS is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. Following placement in the bony voids or gap, OSMOSYS resorbs and is replaced with bone during the healing process.

## Summary Nonclinical Tests

OSMOSYS is similar to the predicate device in terms of composition, porosity, pore size, and resorption.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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APR 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MEDICREA TECHNOLOGIES C/o Mr. J.D. Webb OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K050490

Trade/Device Name: OSMOSYS Calcium Phosphate Ceramic Bone Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: February 21, 2005 Received: March 02, 2005

Dear Mr. Webb:

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 docs 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- Mr. J.D. Webb

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/industry/support/index.html.

Sincerely yours,

Sincerely yours,

Kipt Clurda

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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## Indications for Use

510(k) Number (if known): K050490

Device Name: OSMOSYS Calcium Phosphate Ceramic Bone Filler

Indications for Use:

OSMOSYS is intended for use as a bone void filler to fill bony void gaps of the skeletal system (i.e. the extremities, spine and pelvis) resulting from surgery or trauma that are wa in the system (t.e. the extremities). spine and perviol readers is indicated for use in the not mirmsic to the stability of the bony information or osseous defects created from traimatic treatment of surgically created osseous deroces or easy OSMOSYS resorbs and is replaced with bone during the healing process.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Styk Plodr

(Division Division of General Beatherstiv and Neurological a conce

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50490

510(k) Number