HEMASORBPLUS Resorbable Hemostatic Bone Putty

K153317 · Orthocon, Inc. · MTJ · Nov 30, 2016 · SU

Device Facts

• Record ID: K153317
• Device Name: HEMASORBPLUS Resorbable Hemostatic Bone Putty
• Applicant: Orthocon, Inc.
• Product Code: MTJ · SU
• Decision Date: Nov 30, 2016
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Orthocon HemasorbPlus 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

HemasorbPlus is a sterile, biocompatible, resorbable bone putty used to control bleeding from bone surfaces. It consists of alkylene oxide polymers, vitamin E acetate, granular calcium phosphate, and sodium carboxymethylcellulose. The putty is applied directly to cut or broken bone by a surgeon; it acts as a mechanical barrier (tamponade) to stop bleeding. It requires no pre-warming or kneading and can be mixed 1:1 by volume with autograft. The device is intended for use in surgical settings to facilitate hemostasis and support bone healing.

Clinical Evidence

No human clinical data provided. Evidence includes bench testing (smearability, stickiness, stiffness, temperature sensitivity, dissolution, swelling), ISO 10993 biocompatibility testing (cytotoxicity, irritation, sensitization, toxicity, hemolysis, pyrogenicity), and animal studies confirming hemostasis and safety when mixed 1:1 with autograft.

Technological Characteristics

Putty-like material composed of alkylene oxide polymers, vitamin E acetate, granular calcium phosphate, and sodium carboxymethylcellulose. Sterile, gamma-irradiation sterilized. Mechanical barrier/tamponade principle. No electronic components or software.

Indications for Use

Indicated for control of bleeding from cut or damaged bone in patients requiring surgical or traumatic bone hemostasis.

Predicate Devices

• Hemostatic Bone Putty 3 (K123243)

Submission Summary (Full Text)

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

November 30, 2016

Orthocon, Inc. Howard Schrayer Official Correspondent 1 Bridge Street, Suite 121 Irvington, New York 10533

Re: K153317

Trade/Device Name: Hemasorbplus Resorbable Hemostatic Bone Putty Regulatory Class: Unclassified Product Code: MTJ Dated: November 21, 2016 Received: November 22, 2016

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 devicerelated adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David-Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K153317

Device Name

HemasorbPlus Resorbable Hemostatic Bone Putty

Indications for Use (Describe)

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

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Arial;"> </span> </span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### 510(k) SUMMARY (Per 21 CFR 807.92)

#### General Company Information

Name: Orthocon. Inc. Contact: Howard Schrayer Requlatory Affairs Consultant Address: 1 Bridge Street, Suite 121 Irvington, NY 10533 Telephone: (609) 924 - 9510 Fax: (914) 231 - 7884

Date Prepared November 29, 2016

### General Device Information

510(k) Number: K153317 Product Name: HEMASORBPLUS™ Resorbable Hemostatic Bone Putty Classification: "Bone Wax", Product code: MTJ Requlation: Unclassified

#### Predicate Device

Orthocon. Inc. - Hemostatic Bone Putty 3 510(k) Number: K123243

#### Description

HEMASORBPLUS™ Resorbable Hemostatic Bone Putty is a sterile, biocompatible, resorbable material of putty-like consistency for use in the control of bleeding from bone surfaces. The material contains a mixture of alkylene oxide polymer based materials, vitamin E acetate, granular calcium phosphate and sodium carboxymethylcellulose. HEMASORBPLUS™ Resorbable Hemostatic Bone Putty is virtually odorless, off-white in color and can be spread easily onto bone with minimal adhesion to surgical gloves. The putty requires no kneading or warming prior to application. When applied to surgically cut or traumatically broken bone, HEMASORBPLUS™ Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). HEMASORBPLUS Resorbable Hemostatic Bone Putty has been shown to be mixable with autograft in a 1:1 volume ratio.

#### Indications For Use

Orthocon HEMASORBPLUS 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.

#### Purpose of Submission

Orthocon is proposing to modify the labeling (Instructions for Use) to provide information regarding use of this device when mixed in a 1:1 ratio with autograft.

#### Testing Completed on Original Configuration

The following testing was completed on the original (predicate) device and is referenced in the 510(k) Notice because the device formulation is unchanged;

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#### Performance Data

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 and swelling properties. The following bench studies were completed: smearability. stickiness, stiffness, temperature sensitivity, and dissolution and swelling.

#### Biocompatibility Testing

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-irradiation sterilized device and in accordance with the GLP requirements: cytotoxicity, irritation, sensitization, acute systemic toxicity, implantation / subacute toxicity, hemolysis, and pyrogenicity.

#### In Vivo Performance Testing

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

#### Testing Completed to Support Mixing with Autograft

In accordance with design control procedures, Orthocon, Inc. performed a risk analysis for the proposed removal of the "Warning" statement that advised users not combine HEMASORBPLUS Resorbable Hemostatic Bone Putty with autograft. This design control process was based on an FMEA approach. Based on the results of the risk analysis, a study was conducted in laboratory animals to confirm that mixture with autograft in a 1:1 ratio (by volume) provided hemostasis and did not interfere with the normal bone healing process when compared with autograft alone.

#### Substantial Equivalence and Conclusions

This submission supports the position that the Orthocon HEMASORBPLUS Resorbable Hemostatic Bone Putty is substantially equivalent and is exactly the same as the predicate Orthocon HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty [cleared under 510(k) K123243]. Orthocon, Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as Orthocon HEMASORBPLUS Resorbable Hemostatic Bone Putty and that Substantial Equivalence to the predicate device has been established. The data presented demonstrate that the device is suitable for its indicated use. 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 quidelines.