(19 days)
Not Found
No
The device description focuses on the physical and chemical properties of the bone putty and its mechanical function as a hemostatic agent. There is no mention of AI, ML, image processing, or data-driven decision making.
Yes
The device is intended to control bleeding by acting as a mechanical barrier or tamponade, which is a therapeutic function.
No
This device is a resorbable hemostatic bone putty used to control bleeding from bone, primarily acting as a mechanical barrier. It does not perform any diagnostic function.
No
The device description clearly states it is a physical material (putty) composed of calcium stearate, Vitamin E Acetate, and alkylene oxide copolymers, intended for manual application to bone. It functions as a mechanical barrier. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to control bleeding from bone by acting as a mechanical barrier. This is a direct therapeutic action on the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a physical material applied to the bone surface. It does not describe a test or assay performed on a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MTJ
Device 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 mixture 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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 | |||
| Regulatory Affairs Consultant | ||||
| Address: | 167 Stone Hill Road | |||
| 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.
1
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.
2
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.
3
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
4
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