(11 days)
Not Found
No
The device description focuses on the material composition and mechanical action of the bone putty, with no mention of AI or ML technologies.
Yes
The device is indicated for use in the control of bleeding from cut or damaged bone, which is a therapeutic purpose.
No
The device is a hemostatic bone putty used to control bleeding, not to diagnose a condition.
No
The device description clearly states it is a "sterile, soft, moldable, biocompatible, absorbable material of putty-like consistency" composed of physical substances like calcium stearate, Vitamin E Acetate, and alkylene oxide copolymer. This describes a physical medical device, not a software-only one.
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 patient's body.
- Device Description: The description details a physical material applied to the bone surface. It doesn't involve analyzing samples from the body (like blood, urine, or tissue) to provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, measure a substance, or provide information about a patient's health status based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical and therapeutic.
N/A
Intended Use / Indications for Use
Orthocon Orthostat™ 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 Orthostat™ Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible, absorbable material of putty-like consistency intended for use in 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 properties) and alkylene oxide copolymer (a dispersing agent). The material is virtually odorless, off-white 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, Orthostat™ Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). The bone putty will be dispersed and absorbed 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
bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical procedures, treating traumatic injuries
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
K091121 page 1/2
ORTHOCON
APR 2 8 2009
510(k) Summary Of Safety And Effectiveness (Per 21 CFR 4 807.92)
General Company Information
| Name: | Orthocon Inc. |
|---|---|
| Contact: | Kenneth Collins |
| Address: | 675 US Highway One |
| North Brunswick, NJ 08902 | |
| Telephone: | 732.418.0025 |
| Fax: | 732-418-0221 |
| Date Prepared: | March 30, 2009 |
General Device Information
| Product Name: | Orthostat™ Hemostatic Bone Putty |
|---|---|
| Classification: | Unclassified |
| : | "Bone Wax". Product code: MTJ |
Predicate Device
| Device Name: | Orthostat™ Hemostatic Bone Putty |
|---|---|
| 510(k) Number: | 043260 |
| Decision Date: | August 12, 2005 |
| Decision: | Substantially Equivalent (SE) |
Device Description
Orthocon Orthostat™ Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible, absorbable material of putty-like consistency intended for use in 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 properties) and alkylene oxide copolymer (a dispersing agent). The material is virtually odorless, off-white 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, Orthostat™ Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). The bone putty will be dispersed and absorbed within a period of 60 days.
1
K091121 Page 42
ORTHOCON
Intended Use (Indications)
Orthocon Orthostat™ 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
In this Special 510(k) submission the device is its own predicate. Orthostat™ Hemostatic Bone Putty is unchanged in its formulation from its predicate 510(k) clearance. The Indications for Use also remain unchaged. This Special 510(k) is to add the following contraindications to the labeling of the device.
Do not use Orthostat in joints or in contact with synovial membrane or in procedures where the material will be in direct intra-articular contact with the joint (e.g. bunionectomy).
Do not use Orthostat as a bone void filler or graft extender.
This Special 510(k) Notice contains revised Risk Management documents, summaries of biocompatibility testing and reports from investigations of the use of the device. Conformance to applicable Special Controls has been verified.
The data presented demonstrate the substantial equivalence of the modified device to the original device.
2
Image /page/2/Picture/1 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" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Orthocon Corporation % Dr. Kenneth A. Collins 675 US Highway One North Brunswick, New Jersey 08902
APR 2 8 2009
Re: K091121
Regulatory Class: Unclassified Product Code: MTJ Dated: April 15, 2009 Received: April 17, 2009
Dear Dr. Collins:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 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.
3
Page 2 - Dr. Kenneth A. Collins
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 N. Melkerson
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ORTHO
- The Role of the State in the Economy The role of the state in the economy is a complex and multifaceted issue that has been debated for centuries. There are many different perspectives on what the state's role should be, ranging from laissez-faire capitalism, where the state plays a minimal role, to socialism, where the state controls most of the economy. In general, the state plays a role in the economy by providing public goods and services, regulating economic activity, and redistributing income. Public goods and services are those that are non-excludable and non-rivalrous, meaning that they are available to everyone and that one person's use of them does not diminish their availability to others. Examples of public goods and services include national defense, law enforcement, and infrastructure. The state also regulates economic activity to protect consumers, workers, and the environment. Regulations can take many forms, such as setting minimum wages, banning certain products, and requiring businesses to meet certain standards. Finally, the state redistributes income through taxes and transfer payments. Taxes are used to fund public goods and services, while transfer payments are used to provide income support to low-income individuals and families. The appropriate role of the state in the economy is a matter of ongoing debate. There are many different perspectives on what the state's role should be, and there is no easy answer. However, it is clear that the state plays a significant role in the economy, and that its actions can have a major impact on people's lives.
2.1 Orthostat™ Indications for Use
510(k) Number (if known): K09
Device Name:
Orthostat™ Hemostatic Bone Putty
Indications for Use:
Orthocon Orthostat™ 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krone for MXM
(Division Sign-C Division of General, Restorative, and Neurological Devices
510(k) Number K091121