(121 days)
Not Found
No
The device description and intended use are for a mechanical screw system and associated instruments, with no mention of software, algorithms, or AI/ML capabilities.
No
The device, a screw system, is used for mechanical support in bone repair and fixation rather than directly treating a disease or condition therapeutically.
No
The device is a system of screws and instruments for surgical procedures like bone reconstruction and fracture repair, not for diagnosing medical conditions.
No
The device description explicitly states that the system is comprised of screws made of Titanium Alloy and includes various surgical instruments (guide wires, drills, taps, drivers, etc.), indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The Osteomed Headless Cannulated Screw System is a surgical implant used for bone repair and fixation. It is physically inserted into the body to provide structural support.
- Lack of Diagnostic Testing: The description and intended use do not mention any form of testing on biological samples or providing diagnostic information.
This device is a surgical implant/orthopedic device, not an IVD.
N/A
Intended Use / Indications for Use
The Osteomed Headless Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.
Product codes
HWC
Device Description
The OsteoMed Headless Cannulated Screw system is comprised of screws in diameters of 2.0mm (10-42mm length), 2.4mm (10-50mm length), 3.0mm (10-40mm length), 4.0mm (12-52mm length) and 6.5mm (40-120mm length). The screws are made of Titanium Alloy (ASTM F-136). Guide Wires, drills, taps, drivers, handle, depth gauge, bone clamp, screw extractor and preparation instruments will also be a part of the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones
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)
K060071, K043102, K792022, K014154, K954330
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
510(k) Summary
MAR 0 2 2007
Device Proprietary Name:
Device Common Name:
Classification Name:
Name of Submitter:
OsteoMed Headless Cannulated Screw System
Bone Screw
HWC, Screw, Fixation, Bone
OsteoMed L. P. 3885 Arapaho Road Addison, Texas 75001 Phone: (972) 677-4600 Fax: (972) 677-4601
Contact Person:
Date Prepared:
Dawn D. Tindall October 31 . 2006
Summary:
This submission describes the OsteoMed Headless Cannulated Screw System indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.
The OsteoMed Headless Cannulated Screw system is comprised of screws in diameters of 2.0mm (10-42mm length), 2.4mm (10-50mm length), 3.0mm (10-40mm length), 4.0mm (12-52mm length) and 6.5mm (40-120mm length). The screws are made of Titanium Alloy (ASTM F-136). Guide Wires, drills, taps, drivers, handle, depth gauge, bone clamp, screw extractor and preparation instruments will also be a part of the system.
Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Nexa Compression Pin cleared under K060071, the Wright Multi Use Compression Screw (K043102), the Zimmer Herbert Bone Screw (K792022), the Vilex/Duval/Orthex Cannulated Bone Screw (K014154) and the OsteoMed Super Screw System (K954330).
Due to the similarity of materials and design to both pre-enactment and postenactment devices, OsteoMed believes that the OsteoMed Headless Cannulated Screw System does not raise any new safety or effectiveness issues.
OsteoMed L.P. 3885 Arapaho Road Addison, Texas 75001 (972) 677-4600 FAX: (972) 677-4601 Customer Service: (800) 456-7779
Image /page/0/Picture/21 description: The image shows a logo with the word "Colson" in a stylized font. The logo also includes the text "A COLSON ASSO", which is likely part of a company or organization name. The logo appears to be for a company named Colson or an organization associated with Colson.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the HHS logo, which consists of a stylized caduceus symbol with three wavy lines representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OsteoMed L.P. % Ms. Dawn D. Tindall 3885 Arapaho Road Addison, Texas 75001
MAR 0 2 2007
K063298 Re: Trade/Device Name: OsteoMed Headless Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener. Regulatory Class: II Product Code: HWC Dated: February 5, 2007 Received: February 6, 2007
Dear Ms. Tindall:
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 (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Dawn D. Tindall
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 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) 276-0120. 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 N Mikkelsen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K063298 / S00 1
Device Name: __ OsteoMed Headless Cannulated Screw System Indications for Use:
The Osteomed Headless Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.
Prescription Use (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)
(Posted November 13, 2003)
Mark A. Millken
Page of
(Division Sign-Off) Division of Ceneral, Restorative, and Neurole Jeal Devices
510(k) Number.