ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY

K063330 · Orthocon, Inc. · MTJ · Nov 22, 2006 · SU

Device Facts

• Record ID: K063330
• Device Name: ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY
• Applicant: Orthocon, Inc.
• Product Code: MTJ · SU
• Decision Date: Nov 22, 2006
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Orthocon HemaSorb™ Resorbable Hemostatic Bone Putty is indicated for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries.

Device Story

HemaSorb is a sterile, moldable, resorbable bone putty used to control bleeding from cut or damaged bone. It acts as a mechanical barrier (tamponade) when applied manually to the bone surface. The device is composed of calcium stearate, Vitamin E Acetate, and alkylene oxide copolymers. It requires no pre-application kneading and maintains consistency at body temperature. It is intended for use by surgeons during surgical procedures or trauma care. The material is designed to be dispersed and resorbed by the body within 60 days, eliminating the need for removal.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and established history of use of the constituent materials.

Technological Characteristics

Sterile, moldable, resorbable putty. Composition: calcium stearate (tamponade), Vitamin E Acetate (handling properties), and alkylene oxide copolymers (dispersing agent). Mechanical barrier principle. No energy source. No software.

Indications for Use

Indicated for control of bleeding from cut or damaged bone via mechanical tamponade in patients undergoing surgical procedures or receiving treatment for traumatic bone injuries.

Predicate Devices

• OrthoStat Resorbable Hemostatic Bone Putty (K043260)

Submission Summary (Full Text)

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K063330 page 1/2

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)

### General Company Information

| Name: | Orthocon, Inc. | | | Nov 2 2006 |
|----------------------------|--------------------------------------------------|--|--|------------|
| Contact: | Howard Schrayer<br>Regulatory Affairs Consultant | | | |
| Address: | 167 Stone Hill Road<br>Colts Neck, NJ 07722 | | | |
| Telephone: | (732) 683 - 9304 | | | |
| Fax: | (732) 683 - 9476 | | | |
| Date Prepared | November 1, 2006 | | | |
| General Device Information | | | | |
| Product Name: | HemaSorb™ Resorbable Hemostatic Bone Putty | | | |
| Classification: | "Bone Wax", Product code: MTJ | | | |

#### Predicate Device

Unclassified

Orthocon, Inc. - OrthoStat Resorbable Hemostatic Bone Putty 510(k) Number K043260

# Description

Orthocon HemaSorb™ Resorbable Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible, resorbable material of putty-like consistency intended for use it the management of bleeding from the cut surface of bone. The material is a mxture of calcium stearate (a wax-like tamponade), Vitamin E Acetate (for handling mroperties) and alkylene oxide copolymers (a dispersing agent). The material is virtualling proponicos, offwhite in color and can be spread easily with minimal adhesion to surgical gloves, The bone putty requires no kneading prior to application and does not soften appreciably at body temperature.

When applied manually to surgically incised or traumatically broken bone, HemaSorb Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). The bone putty will be dispersed and resorbed within a period of 60 days.

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K063330 Page 2/2

#### Intended Use (Indications)

Orthocon HemaSorb™ Resorbable Hemostatic Bone Putty is indicated for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries.

#### Substantial Equivalence

This submission supports the position that the Orthocon HemaSorb™ Resorbable Hemostatic Bone Putty is substantially equivalent to a number of pre-enactment and previously cleared devices, including:

Orthocon, Inc. – OrthoStat Resorbable Hemostatic Bone Putty - 510(k) Number K043260

The 510(k) Notice contains summaries of studies conducted to demonstrate substantial equivalence and a description of the modification made to the composition.

The data presented demonstrate that the device is suitable for its indicated use.

#### Conclusions

Orthocon, Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the Orthocon HemaSorb™ Resorbable Hemostatic Bone Putty. The materials from which the Orthocon device is fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA guidelines.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Orthocon, Inc. % Mr. Howard L. Schrayer 167 Stone Hill Road Colts Neck, New Jersey 07722

NOV 2 2 2006

Re: K063330

Trade/Device Name: Orthocon, HemaSorb™ Resorbable Hemostatic Bone Putty Regulatory Class: Unclassified Product Code: MTJ Dated: November 2, 2006 Received: November 3, 2006

Dear Mr. Schrayer:

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 (Scctions 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

Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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Page 2 – Mr. Howard L. Schrayer

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,

Mark M. Milliman

Mark N. Melkerson 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): KO63330

Device Name: Orthocon, HemaSorb™ Resorbable Hemostatic Bone Putty

Indications For Use:

The Orthocon HemaSorb™ Resorbable Hemostatic Bone Putty is indicated for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Pelotmo

eral, Restorative. and Neurological Devices

510(k) Number L06336