(30 days)
Not Found
No
The summary describes a mechanical orthopedic implant and its associated instruments, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an implantable screw intended for fixation of fractures, non-unions, arthrodeses, and osteotomies, which are therapeutic interventions for musculoskeletal conditions.
No.
The device description and intended use clearly state that the Tiger Headless Cannulated Screws are implants used for fixation of fractures, non-unions, arthrodeses, and osteotomies. They are instruments for management of bone conditions, not for diagnosing them.
No
The device description clearly states it is a system of physical screws and instruments, which are hardware 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 the "fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones In the hand and foot." This describes a surgical implant used directly on the patient's body for structural support and repair.
- Device Description: The description confirms it's a "headless, cannulated, self-drilling, self-tapping screws" and mentions "implants." This further reinforces its nature as a physical device implanted in the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health status, which is the core function of an IVD.
Therefore, the Tiger Headless Cannulated Screws are a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Tiger Headless Cannulated Screws are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones In the hand and foot.
Product codes
HWC
Device Description
Tiger Headless Cannulated Screws are headless, cannulated, self-drilling, self-tapping screws for the management of small bone orthopedic osteotomies and trauma. The system consists of multiple screw lengths and diameters and the necessary instruments to facilitate the placement of these implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and foot
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)
The components were subjected to static axial pull out testing, static axial pull through testing, driving torque and failure torque.
The results of this testing indicate that the Tiger Headless Cannulated Screws are equivalent to the predicate devices.
No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 for the Tiger Headless Cannulated Screws
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Tiger Headless Cannulated Screws
1. GENERAL INFORMATION
| Date Prepared: September 14, 2011 |
|---|
| Trade Name: Tiger Headless Cannulated Screws |
| Common Name: Bone Screw |
| Classification Name: Smooth & threaded metallic bone fixation fasteners |
| Class: II |
| Product Code: HWC |
| CFR section: 21 CFR section 888.3040 |
| Device panel: Orthopedic |
| Legally Marketed Tiger Cannulated screws (K081510) |
| Predicate Device: 2.4 and 3.0mm Headless Compression Screws (K050636/K021556) |
| Submitter: Trilliant Surgical LTD |
| 602 Sawyer Street, Suite 120 |
| Houston, TX 77007 |
| Telephone: 214-288-1035 |
| Contact: J.D. Webb |
| 1001 Oakwood Blvd |
| Round Rock, TX 78681 |
| 512-388-0199 |
| e-mail: ortho.medix@shcglobal.net |
2. DEVICE DESCRIPTION
Tiger Headless Cannulated Screws are headless, cannulated, self-drilling, self-tapping screws for the management of small bone orthopedic osteotomies and trauma. The system consists of multiple screw lengths and diameters and the necessary instruments to facilitate the placement of these implants.
Change from Predicate:
The change from the predicate device is a dimensional and geometry change.
Materials:
Ti-6Al-4V alloy per ASTM F136
Function:
The Tiger Headless Cannulated Screws are used to reduce and hold in place bone fragments, and are tightened to further compress the fragments and hold the reduction.
3. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES
The Tiger Headless Cannulated Screws are substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances.
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4. INTENDED USE
The Tiger Headless Cannulated Screws are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones In the hand and foot.
5. NON-CLINICAL TEST SUMMARY
The components were subjected to static axial pull out testing, static axial pull through testing, driving torque and failure torque.
The results of this testing indicate that the Tiger Headless Cannulated Screws are equivalent to the predicate devices.
6. CLINICAL TEST SUMMARY
No clinical studies were performed
7. CONCLUSIONS NONCLINICAL AND CLINICAL
The Tiger Headless Cannulated Screws are substantially equivalent to the predicate devices in terms of indications for use, design, material, performance and function.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or protecting another person, representing the department's mission of protecting the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
OCT 2 0 2011
Trilliant Surgical LTD % J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681
Re: K112737
Trade/Device Name: Tiger Headless Cannulated Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth & threaded metallic bone fixation fasteners Regulatory Class: II Product Code: HWC Dated: September 14th, 2011 Received: September 20th, 2011
Dear Mr. Webb:
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.
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Page 2 – Mr. J.D. Webb
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 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/ucm1.15809.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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Erine Keith
ForMark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Tiger Headless Cannulated Screws
Indications for Use:
The Tiger Headless Cannulated Screws are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones In the hand and foot.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
lielandhens for MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112737)