HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY

K123243 · Orthocon, Inc. · MTJ · Apr 5, 2013 · SU

Device Facts

• Record ID: K123243
• Device Name: HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY
• Applicant: Orthocon, Inc.
• Product Code: MTJ · SU
• Decision Date: Apr 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

Device Story

Hemostatic Bone Putty 3 is a sterile, moldable, resorbable putty used to control bleeding from bone surfaces. It acts as a mechanical barrier or tamponade. The putty is composed of alkylene oxide polymer-based materials, vitamin E acetate, granular calcium phosphate, and carboxymethylcellulose sodium salt. It is applied directly to bone surfaces by a surgeon; it does not require kneading prior to use and exhibits minimal adhesion to surgical gloves. The device is intended for use in surgical settings where bone bleeding occurs. By providing a physical seal, it aids in hemostasis, potentially reducing blood loss during procedures involving bone cutting or damage.

Clinical Evidence

No clinical data. Evidence consists of bench testing and animal studies. Bench testing evaluated handling (stiffness, spreadability, stickiness), temperature sensitivity, electrocautery compatibility, dissolution, and swelling. Biocompatibility testing (ISO 10993) included irritation, sensitization, acute systemic toxicity, genotoxicity, implantation/subacute toxicity, LAL, and pyrogenicity. Animal studies demonstrated intraoperative in vivo hemostasis, resistance to irrigation, device removal, and absorption time.

Technological Characteristics

Sterile, moldable putty. Composition: alkylene oxide polymer-based materials, vitamin E acetate, granular calcium phosphate, carboxymethylcellulose sodium salt. Water-soluble and resorbable. Gamma-radiation sterilized. No electronic components or software.

Indications for Use

Indicated for control of bleeding from cut or damaged bone in patients requiring mechanical barrier or tamponade for hemostasis.

Predicate Devices

• Ostene® AOC Bone Wax (K041363)
• US Surgical Auto Suture Bone Wax (K971680)
• Skeletal Kinetics CAAP (Calcium Apatite) Bone Wax (K111538)
• CP Medical Bone Wax (K024372)

Submission Summary (Full Text)

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Traditional 510(K) HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty

## 510(k) Summary

| Contact: | Howard Schrayer<br>Orthocon, Inc.<br>1 Bridge Street, Suite 121<br>Irvington, NY 10533<br>Telephone: [phone]<br>Fax: [phone]<br>[e-mail] | APR | 5 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|---|
| Date Prepared: | October 15, 2012 | | |
| Device Trade Name: | HEMOSTATIC BONE PUTTY 3<br>Resorbable Hemostatic Bone Putty | | |
| Manufacturer: | Orthocon, Inc.<br>1 Bridge Street, Suite 121<br>Irvington, NY 10533 | | |
| Common Name: | Bone wax | | |
| Classification: | Unclassified | | |
| Product Code: | MTJ | | |

Indications for Use:

HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. ·

#### Device Description:

HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible formulation comprised of water soluble and resorbable materials in a putty-like consistency intended for use in the control of bleeding from bone surfaces by acting as a mechanical barrier or tamponade. The putty is a mixture of alkylene oxide polymer-based materials, vitamin E acetate, granular calcium phosphate, and carboxymethylcellulose sodium salt. The material is virtually odorless, off-white in color and can be spread easily onto bone with minimal adhesion to surgical gloves. The bone putty does not require kneading prior to application.

2013

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### Substantial Equivalence and Predicate Devices:

The device was shown to be substantially equivalent to previously cleared bone wax devices including Ostene® AOC Bone Wax (K041363), US Surgical Auto Suture Bone Wax (K971680), and Skeletal Kinetics CAAP (Calcium Apatite) Bone Wax (K111538), and traditional nonabsorbable bone wax devices, including CP Medical Bone Wax (K024372).

Traditional 510(K)

#### Performance Testing:

Bench testing; biocompatibility and animal functionality testing performed on the HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty demonstrate that the device is substantially equivalent to predicate devices in intended use, technological characteristics, and performance. This testing included the following:

Bench Testing was conducted to verify the device's handling properties, to characterize the device's performance over a range of temperatures and to evaluate the device's dissolution properties. The following bench studies were completed: relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility, dissolution and swelling.

Biocompatibility Testing was conducted to evaluate the device's biocompatibility in accordance with the recommendations of ISO 10993. The following biocompatibility studies were conducted on the final, finished, gamma-radiation sterilized device in accordance with GLP requirements: irritation, sensitization, acute systemic toxicity, genotoxicity, implantation/subacute toxicity, LAL and pyrogenicity.

Animal Testing included animal studies to demonstrate intraoperative in vivo hemostasis, resistance to irrigation, ability to remove the device, and to characterize absorption time.

#### Conclusion

HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty is substantially equivalent to previously cleared and preamendment bone wax devices with respect to intended use, general technological characteristics and performance.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The logo is black and white.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter dated: April 5, 2013

Orthocon, Inc. % Mr. Howard Schrayer One Bridge Street, Suite 121 Irvington, New York 10533

Re: K123243

Trade/Device Name: Hemostatic Bone Putty 3 Resorbable Hemostatic Bone Putty Regulatory Class: Unclassified Product Code: MTJ Dated: March 11, 2013 Received: March 12, 2013

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Howard Schrayer

forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark Newelkerson -S

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

Enclosure

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#### Traditional 510(K) HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty

#### Indications for Use

510(k) Number (if known): K123243

Device Name: HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty

HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

Prescription Use ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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David Krause/g

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123243

CONFIDENTIAL