(140 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of the implants and instruments, with no mention of AI or ML capabilities.
No.
The device is strictly for bone fusion and arthrodesis, which are surgical procedures, not therapeutic treatments.
No.
The device is an orthopedic surgical system used for bone fusion and arthrodesis, not for diagnosing medical conditions.
No
The device description explicitly states it consists of plates, fusion screws, and surgical instruments made of physical materials like Titanium and Stainless Steel. It also describes mechanical strength testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "bone fusion and arthrodesis of phalanges and metacarpals." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of "plates, fusion screws and surgical instruments" made of materials like Titanium and Stainless Steel. These are physical implants and tools used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to aid in diagnosis, monitoring, or screening. This device is a surgical implant system used for structural support and fusion within the body.
N/A
Intended Use / Indications for Use
OsteoMed Hand Fusion System is intended for use in bone fusion and arthrodesis of phalanges and metacarpals. It is intended for use in trauma, general surgery and reconstructive procedure.
The OsteoMed Hand Fusion System implants are intended for single use only.
Product codes
HRS, HWC
Device Description
The OsteoMed Hand Fusion System consists of plates, fusion screws and surgical instruments. Plates and fusion screws are provided in various sizes. The implants are made of Titanium (ASTM F-67 or ASTM F-136) or Stainless Steel (ASTM F-138 or ASTM F-139).
Surgical instrumentation is provided to facilitate modification, insertion, and removal of implants. These instrüments are made from various grades of stainless steel, anodized aluminum, and/or medical grade polymers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
phalanges and metacarpals
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
An engineering analysis of plate strength was conducted to compare the Fusion plate to the predicate device. Calculations based on cross sectional area and plate material showed that the Fusion plate is able to withstand more load than the predicate device. Mechanical strength testing of the Fusion screw and the Fusion plate and screw construct was performed to further prove substantial equivalence. Test results show that the factor of safety (the ratio of failure torque to insertion torque) of the Fusion screws is equivalent to the factor of safety of the OsteoMed Headless Screws, a predicate listed above. Test results also show the pullout strength of the Fusion screws is equivalent to the pullout strength of the predicate device. Finally, testing of the plate and screw construct showed locking screw engaged with the Fusion plate hole is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K063298, K090522, K063049, K030310
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K111419 #1/2
510(k) Summary
| Date Prepared: | 10/06/11 |
|---|---|
| Name of Submitter: | OsteoMed L. P. |
| 3885 Arapaho Road | |
| Addison, Texas 75001 | |
| Phone: (972) 677-4781 Fax: (972) 677-4778 | |
| Contact Person: | Suzanne Cheang |
| Device Proprietary Name: | OsteoMed Hand Fusion System |
| Common Name: | Hand Fusion System |
| Classification Name: | 21 CFR § 888.3030: Single/multiple component |
| metallic bone fixation appliances and accessories | |
| Product Code: | HRS, HWC |
Device Description:
The OsteoMed Hand Fusion System consists of plates, fusion screws and surgical instruments. Plates and fusion screws are provided in various sizes. The implants are made of Titanium (ASTM F-67 or ASTM F-136) or Stainless Steel (ASTM F-138 or ASTM F-139).
Surgical instrumentation is provided to facilitate modification, insertion, and removal of implants. These instrüments are made from various grades of stainless steel, anodized aluminum, and/or medical grade polymers.
Indication for Use:
OsteoMed Hand Fusion System is intended for use in bone fusion and arthrodesis of phalanges and metacarpals. It is intended for use in trauma, general surgery and reconstructive procedure.
The OsteoMed Hand Fusion System implants are intended for single use only.
1
K111419 *2/2
Substantial Equivalence Information:
K063298 - OsteoMed Cannulated Headless Screw System
K090522 - OsteoMed Hand Plating System
K063049 - Synthes Modular Mini Fragment LCP System
K030310 - Synthes Stainless Steel Modular Hand System
The OsteoMed Hand Fusion System shares dimensional and material characteristics with the OsteoMed Hand Plating System, listed as a predicate above. An engineering analysis of plate strength was conducted to compare the Fusion plate to the predicate device. Calculations based on cross sectional area and plate material showed that the Fusion plate is able to withstand more load than the predicate device. Mechanical strength testing of the Fusion screw and the Fusion plate and screw construct was performed to further prove substantial equivalence. Test results show that the factor of safety (the ratio of failure torque to insertion torque) of the Fusion screws is equivalent to the factor of safety of the OsteoMed Headless Screws, a predicate listed above. Test results also show the pullout strength of the Fusion screws is equivalent to the pullout strength of the predicate device. Finally, testing of the plate and screw construct showed locking screw engaged with the Fusion plate hole is substantially equivalent to the predicate devices.
Based upon similarities in the operational principle, design features, material and intended use to the predicate devices, the safety and effectiveness of the OsteoMed Hand Fusion System is substantially equivalent to the predicate devices listed above.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OsteoMed L.P. % Ms. Suzanne Cheang 3885 Arapaho Road Addison. Texas 75001
OCT - 7 2011
Re: K111419 Trade/Device Name: OsteoMed Hand Fusion System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: September 27, 2011 Received: September 28, 2011
Dear Ms. Cheang:
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
3
Page 2 - Ms. Suzanne Cheang
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.
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/Reportal?roblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K111419
Device Name: OsteoMed Hand Fusion System
Indications for Use:
OsteoMed Hand Fusion System is intended for use in bone fusion and arthrodesis of phalanges and metacarpals. It is intended for use in trauma, general surgery and reconstructive procedure.
The OsteoMed Hand Fusion System implants are intended for single use only.
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)
の 2007年07月 08:00 00000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
Mitra Allen for MXM
(Division Sign-Off)
Page 1 of 1
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111419