(92 days)
Not Found
No
The device description and intended use are for a mechanical trauma screw, and there is no mention of AI, ML, image processing, or data analysis capabilities.
No
The device, a trauma screw, is intended for mechanical purposes like fixation and compression of bones, not for treating or curing a disease or medical condition in a therapeutic sense.
No
Explanation: The device is a trauma screw used for compression and fixation, which are treatment (therapeutic) functions, not diagnostic ones. Its "Intended Use" describes surgical procedures (bone reconstruction, fracture repair, etc.), not the identification or analysis of medical conditions.
No
The device description clearly states it is a "trauma screw" and mentions physical materials like "titanium and stainless steel," indicating it is a physical implant, not software.
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 description and intended use clearly state that this device is a trauma screw designed for surgical implantation to fix and compress bone. It is a physical implant used directly on the patient's anatomy.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, this device falls under the category of a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
A trauma screw designed to apply compression and fixation between two adjacent segments of cortical and/or calcaneus bone. The Tyber Medical Trauma Screws are 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 (comma separated list FDA assigned to the subject device)
HWC
Device Description
General trauma screw for compression and fixation of bone. The sterile and non-sterile implants come solid and cannulated, titanium and stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones appropriate for the size of the device
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)
Non-clinical mechanical testing was performed consisting of Pullout and Torsional Yield per ASTM F564. All data indicates the device is substantial equivalence to the predicate systems Clinical data and conclusions were not needed for this device.
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
§ 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
K133842 (pg 1/1) 510(k) Premarket Notification
510(k) Summary of Safety and Effectiveness:
TYBER MEDICAL Interbody System
| Submitter by: | Tyber Medical LLC
89 Headquarters Plaza North, #1464
Morristown, New Jersey 07960 |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Jeff Tyber
CEO and President
Phone: (303) 717-5060 Fax: (866) 889-9914
Email: jtyber@tybermed.com |
| Date Prepared | December 17, 2013 |
| Common Names | Bone Compression Screw |
| Trade Name | Tyber Medical Trauma Screw |
| Classification Name
and Number | Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040) |
| Product Code | HWC |
| Predicate Devices | 1. WRIGHT COMPRESSION SCREWS; Wright Medical - K082320
2. HEADLESS COMPRESSION SCREW; Synthes - K021556
3. VILEX/DUAL CANNULATED BONE SCREW; Vilex - K973309 |
| Device Description | General trauma screw for compression and fixation of bone. The sterile and
non-sterile implants come solid and cannulated, titanium and stainless steel. |
| Intended Use/
Indications for use | A trauma screw designed to apply compression and fixation between two
adjacent segments of cortical and/or calcaneus bone.
The Tyber Medical Trauma Screws are 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. |
| Performance Data
(Non-Clinical and/or
Clinical) | Non-clinical mechanical testing was performed consisting of Pullout and
Torsional Yield per ASTM F564. All data indicates the device is substantial
equivalence to the predicate systems
Clinical data and conclusions were not needed for this device. |
| Statement of
Technological
Comparison | The Tyber Medical Trauma Screw and its predicate devices have the same
indications for use; same design; are made of similar materials, same
application, and have the same anatomic mechanical properties. |
| Conclusion | The Tyber Medical Trauma Screw is substantially equivalent to its predicate
devices. This conclusion is based upon indications for use, materials, design,
test data and principles of operation. |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20. 2014
Tyber Medical LLC Mr. Jeff Tyber President and CEO 89 Headquarters Plaza North, #1464 Morristown, New Jersey 07960
Re: K133842
Trade/Device Name: Tyber Medical Trauma Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: December 18, 2013 Received: December 23, 2014
Dear Mr. Tyber:
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 device-rclated adverse events) (21 CFR 803); good manufacturing practice requirements as set
2
Page 2 - Mr. Jeff Tyber
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 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" (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/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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wigqins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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TYBER MEDICAL Trauma Screw
510(k) Premarket Notification
Indications for Use
510(k) Number (if known):
Device Name:
K133842 (pg 1/1)
Indications for Use:
Tyber Medical Trauma Screw
The Tyber Medical Trauma Screws are 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 X AND/OR Over-the-counter (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth动态rank -S
Division of Orthopedic Devices