(92 days)
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.
General trauma screw for compression and fixation of bone. The sterile and non-sterile implants come solid and cannulated, titanium and stainless steel.
This document describes K133842 for the Tyber Medical Trauma Screw.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Set by ASTM F544) | Reported Device Performance (Tyber Medical Trauma Screw) |
|---|---|
| Pullout strength as per ASTM F544 | All data indicates the device is substantially equivalent to the predicate systems |
| Torsional Yield as per ASTM F544 | All data indicates the device is substantially equivalent to the predicate systems |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a distinct "test set" and instead refers to non-clinical mechanical testing. The sample size for this mechanical testing is not explicitly stated. The data provenance is non-clinical, meaning it originates from laboratory testing. No information is provided regarding country of origin or whether it's retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This device is a mechanical implant, and its performance is evaluated through objective mechanical tests (Pullout and Torsional Yield) rather than relying on expert-established ground truth like in image-based diagnostic devices.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods are typically used when subjective assessments or multiple reader interpretations are involved, which is not the case for mechanical testing of a bone screw.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a medical device (bone screw), not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. Standalone Performance Study:
Yes, a standalone performance study was done in the form of non-clinical mechanical testing. The study evaluated the Tyber Medical Trauma Screw's Pullout and Torsional Yield strength. The results indicated substantial equivalence to predicate devices.
7. Type of Ground Truth Used:
The "ground truth" for this device's performance is established by the standardized requirements and testing methods defined in ASTM F544 for pullout and torsional yield strength. The performance is assessed against these established mechanical properties.
8. Sample Size for the Training Set:
Not applicable. This device does not involve a "training set" in the context of machine learning or AI algorithms. It's a physical medical device.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for this device.
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K133842 (pg 1/1) 510(k) Premarket Notification
510(k) Summary of Safety and Effectiveness:
TYBER MEDICAL Interbody System
| Submitter by: | Tyber Medical LLC89 Headquarters Plaza North, #1464Morristown, New Jersey 07960 |
|---|---|
| Contact Person | Jeff TyberCEO and PresidentPhone: (303) 717-5060 Fax: (866) 889-9914Email: jtyber@tybermed.com |
| Date Prepared | December 17, 2013 |
| Common Names | Bone Compression Screw |
| Trade Name | Tyber Medical Trauma Screw |
| Classification Nameand Number | Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040) |
| Product Code | HWC |
| Predicate Devices | 1. WRIGHT COMPRESSION SCREWS; Wright Medical - K0823202. HEADLESS COMPRESSION SCREW; Synthes - K0215563. VILEX/DUAL CANNULATED BONE SCREW; Vilex - K973309 |
| Device Description | General trauma screw for compression and fixation of bone. The sterile andnon-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 twoadjacent segments of cortical and/or calcaneus bone.The Tyber Medical Trauma Screws are indicated for use in bonereconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, andfracture fixation of bones appropriate for the size of the device. Screws areintended for single use only. |
| Performance Data(Non-Clinical and/orClinical) | Non-clinical mechanical testing was performed consisting of Pullout andTorsional Yield per ASTM F564. All data indicates the device is substantialequivalence to the predicate systemsClinical data and conclusions were not needed for this device. |
| Statement ofTechnologicalComparison | The Tyber Medical Trauma Screw and its predicate devices have the sameindications for use; same design; are made of similar materials, sameapplication, and have the same anatomic mechanical properties. |
| Conclusion | The Tyber Medical Trauma Screw is substantially equivalent to its predicatedevices. 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
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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
§ 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.