HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY

K113627 · Orthocon · MTJ · Feb 17, 2012 · SU

Device Facts

• Record ID: K113627
• Device Name: HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY
• Applicant: Orthocon
• Product Code: MTJ · SU
• Decision Date: Feb 17, 2012
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Hemasorb Resorbable Hemostatic Bone Putty is intended 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, absorbable bone putty composed of calcium stearate, vitamin E acetate, and a liquid surfactant. It functions as a mechanical barrier or tamponade to control bleeding from cut or damaged bone. The device is applied by a surgeon during surgical procedures or trauma treatment. The subject of this 510(k) is the addition of a spatula as an alternative application method. The putty requires no kneading, does not soften at body temperature, and exhibits minimal adhesion to surgical gloves. It provides a physical seal to stop bone bleeding, aiding in surgical site management.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included simulated use, shipping, mechanical testing (cyclic compression and tensile failure), finite element analysis, and stability/sterile package integrity testing.

Technological Characteristics

Composition: calcium stearate, vitamin E acetate, liquid surfactant. Form: sterile, soft, moldable, absorbable putty. Application: manual or via spatula. Mechanical properties: does not soften at body temperature, minimal glove adhesion. Sterilization: not specified.

Indications for Use

Indicated for control of bleeding from cut or damaged bone in surgical procedures or traumatic injuries. No specific age or gender restrictions provided.

Predicate Devices

• K043260
• K102762

Submission Summary (Full Text)

{0}------------------------------------------------

K113627 68 1 64 5

FEB 1 7 2012

## 510(k) Summary

| Contact: | Rosemary Harry<br>Vice President, Regulatory and Quality Affairs<br>Orthocon, Inc<br>1 Bridge Street, Suite 121<br>Irvington, NY 10533<br>[e-mail]<br>914-357-2600 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | January 18, 2012 |
| Device Trade Name: | Hemasorb® Resorbable Hemostatic Bone Putty |
| Manufacturer: | Orthocon, Inc.<br>1 Bridge Street<br>Suite 121<br>Irvington, NY 10533 |
| Common Name: | Wax, bone |
| Classification: | None applicable |
| Class: | Unclassified |
| Product Code: | MTI |

### Indications For Use:

Hemasorb Resorbable Hemostatic Bone Putty is intended 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 Description:

Orthocon Hemasorb Resorbable Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible, absorbable material of putty-like consistency intended for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material is a mixture of calcium stearate, vitamin E acetate and a liquid surfactant. The material is virtually odorless, off-white in color and can be spread easily with minimal adhesion to surgical gloves. Hemasorb requires no kneading prior to application and does not soften appreciably at body temperature. The subject of this 510(k) is the addition of a spatula as an alternative method of Hemasorb application.

#### Predicate Devices:

Substantial equivalence was shown with the previously cleared devices in K043260 and K102762.

{1}------------------------------------------------

## Summary of Non-Clinical Performance Testing

The in vitro tests performed were: simulated use and shipping (including mechanical tests of cyclic compression and tensile failure testing), finite element analysis, and stability (including sterile package integrity).

The device was determined to be biocompatible and to demonstrate adequate integrity and performance characteristics.

## Conclusion:

The modification subject to this 510(k) was shown to be substantially equivalent to previously cleared devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure, composed of three curved lines.

Public Health Service

FEB 1 7 2012

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Orthocon, Inc. % Ms. Rosemary Harry VP. RA/QA 1 Bridge Street, Suite 121 · Irvington, New York 10533

Re: K113627

Trade/Device Name: Hemasorb® Resorbable Hemostatic Bone Putty Regulatory Class: Unclassified · Product Code: MTJ Dated: January 18, 2012 Received: January 20, 2012

Dear Ms. Harry:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo have a row a your 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). and Cosmetic Fror (. 10.) has the device, subject to the general controls provisions of the Act. The I ou may, thereforminens of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addition. Trease now. however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Dri has made a and regulations administered by other Federal agencies. You must or uny 1 cithe Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI K I all 607), labornig (21 CFR 803); good manufacturing practice requirements as set

{3}------------------------------------------------

Page 2 - Ms. Rosemary Harry

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Mark A. Milikurn

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# 4. Indications for Use

510(k) Number (if known): 长川3 627

Device Name: Hemasorb® Resorbable Hemostatic Bone Putty

Hemasorb Resorbable Hemostatic Bone Putty is intended for use in the control of Flemaboro Tesserouser Traged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

K11362

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Moore for NXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113627