(22 days)
Not Found
No
The summary describes a mechanical trauma screw and its performance testing, with no mention of AI or ML.
Yes
This device is intended for clinical use in various medical procedures such as bone reconstruction, fracture repair, and joint fusion, indicating its therapeutic purpose.
No
The device, Tyber Medical MST Trauma Screws, is described as a medical implement for bone reconstruction, fracture repair, and fixation. Its intended use is therapeutic, involving physical intervention (screws for compression and fixation of bone), not the identification or analysis of a disease or condition.
No
The device description clearly states it is a physical screw made of titanium, intended for surgical implantation. 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 clearly states the device is for "bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones." This describes a surgical implant used directly on the patient's body.
- Device Description: The description confirms it's a "General trauma screw for compression and fixation of bone." This is a physical device used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Tyber Medical MST 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
HWC
Device Description
General trauma screw for compression and fixation of bone with modified surface treatment (MST). The screws will be provided sterile in both solid and cannulated form, made of from titanium.
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
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
The following tests were performed to demonstrate that the Tyber Medical MST Trauma Screw is substantially equivalent to other predicate device. Pull out Test per ASTM F543 Static Torsion Test per ASTM F543 Biocompatibility evaluation including Cytotoxicity testing per ISO 10993-5. X-ray photoelectron spectroscopy (XPS) was performed to verify the MST Trauma Screw have the same elemental composition as the predicate. The results of these studies showed that the Tyber Medical MST Trauma Screw met the acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
Tyber Medical Trauma Screw – K133842
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 25, 2015
Tyber Medical LLC Mr. Mark F. Schenk Director of QA/RA 89 Headquarters Plaza North, #1464 Morristown, New Jersey 07960
Re: K153180
Trade/Device Name: Tyber Medical MST 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: November 3, 2015 Received: November 3, 2015
Dear Mr. Schenk:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director, Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K153180
Device Name
Tyber Medical MST Trauma Screw
Indications for Use (Describe)
The Tyber Medical MST Trauma Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. Screws are intended for single use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Special 510(k) Summary
as required by section 807.92(c).
Tyber Medical MST Trauma Screw
K 153180
| Updated | 11/23/15 |
|---|---|
| Submitter: | Tyber Medical LLC |
| 89 Headquarters Plaza North, #1464 | |
| Morristown, New Jersey 07960 | |
| Contact Person | Mark F Schenk |
| Director of QA/RA | |
| Phone: (610) 507-8255 Fax: (866) 889-9914 | |
| Email: mschenk@tybermed.com | |
| Trade Name | Tyber Medical MST Trauma Screw |
| Common Name | Bone Compression Screw |
| Device Class | Class II |
| Classification Name | Smooth or threaded metallic bone fixation fastener |
| and Number | 21 CFR 888.3040 |
| Classification Panel: | Orthopedic |
| Product Code | HWC |
| Predicate Devices | Tyber Medical Trauma Screw – K133842 |
| Device Description | General trauma screw for compression and fixation of bone |
| with modified surface treatment (MST). The screws will be | |
| provided sterile in both solid and cannulated form, made of | |
| from titanium. |
4
| Intended Use | A trauma screw designed to apply compression and fixation
between two adjacent segments of cortical and/or calcaneus
bone. |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Tyber Medical MST 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. |
| Statement of
Technological
Comparison and
Fundamental Scientific
Technology | Tyber Medical MST Trauma Screw and its predicate device
have the same indications for use, similar design, similar
materials, technology principles of operation and test
results. |
| ----------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Nonclinical Testing
Summary | The following tests were performed to demonstrate that the
Tyber Medical MST Trauma Screw is substantially equivalent to other
predicate device. Pull out Test per ASTM F543 Static Torsion Test per ASTM F543 Biocompatibility evaluation including Cytotoxicity testing per
ISO 10993-5. X-ray photoelectron spectroscopy (XPS) was performed to
verify the MST Trauma Screw have the same elemental
composition as the predicate. The results of these studies showed that the Tyber Medical MST
Trauma Screw met the acceptance criteria. |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Test Summary | n/a |
| Conclusion | Tyber Medical MST Trauma Screw and its predicate device have the same indications for use, similar design, and test results. Both devices are manufactured using materials with a long history of use in orthopedic implants. |
|---|---|
| ------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |