(56 days)
No
The summary describes a mechanical screw system for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a system of screws used for "fixation of fractures, non-unions, arthrodeses, and osteotomies of bones," which are medical conditions that require treatment.
No
The device is a screw system used for fixation of fractures, non-unions, arthrodeses, and osteotomies, which is a treatment rather than a diagnostic function.
No
The device description explicitly states it is a "screw system" consisting of physical screws, washers, and instruments, which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a system of screws and instruments used for orthopedic procedures. These are physical implants and tools 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical fixation.
N/A
Intended Use / Indications for Use
The Tiger Cannulated Screw System is indicated for fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Tiger Cannulated Screw System is a headed and headless, cannulated, self-drilling, self-tapping screw system for the management of bone orthopedic osteotomies and trauma. The system consists of Ø2.0-Ø7.0 mm screws and washers, and the necessary instruments to facilitate the placement of these implants.
The purpose of this submission is to add Ø5.5 mm and Ø7.0 mm headed cannulated screws to the Tiger Cannulated Screw System and to modify the indications for use statement for previously cleared devices (K081510 / K112737).
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)
The following analyses were conducted:
ASTM F543-07
Torque to Failure
Axial Pullout Strength
Axial Pull Through Strength
Driving/Insertion and Removal Torque
The results of these evaluations indicate that the Tiger Cannulated Screws are equivalent to predicate devices.
No clinical studies were performed
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.
K081510 / K112737, K962011 / K963172 / K963192 / K021556, K063298 / K151021
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, and they are connected by a flowing line.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 14, 2016
Trilliant Surgical, LTD % J.D. Webb President The OrthoMedix Group 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K153338
Trade/Device Name: Tiger Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: November 13, 2015 Received: November 19, 2015
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.
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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)
Device Name
Tiger Cannulated Screw System
Indications for Use (Describe)
The Tiger Cannulated Screw System is indicated for fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.
Type of Use (Select one or both, as applicable)
X | Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary:
| Date Prepared | November 13, 2015 |
|---|---|
| Submitted By | Trilliant Surgical, LTD |
| 6721 Portwest Dr, | |
| Suite 160 | |
| Houston, TX 77024 | |
| 713-388-6055 Tele | |
| jolson@trilliantsurgical.com | |
| Contact | J.D. Webb |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| 512-388-0199 Tele | |
| e-mail: jdwebb@orthomedix.net | |
| Trade Name | Tiger Cannulated Screw System |
| Common Name | Bone screws |
| Classification Name | Smooth & threaded metallic bone fixation fasteners |
| Class | II |
| Product Code | HWC |
| CFR Section | 21 CFR section 888.3040 |
| Device Panel | Orthopedic |
| Primary Predicate | |
| Device | Tiger Cannulated Screw System - K081510 / K112737 |
| Secondary Predicate | |
| Devices | Synthes Cannulated Screws - K962011 / K963172 / K963192 / K021556 |
| Osteomed ExtremiFix Cannulated Screw System - K063298 / K151021 | |
| Device Description | The Tiger Cannulated Screw System is a headed and headless, cannulated, |
| self-drilling, self-tapping screw system for the management of bone orthopedic | |
| osteotomies and trauma. The system consists of Ø2.0-Ø7.0 mm screws and | |
| washers, and the necessary instruments to facilitate the placement of these | |
| implants. | |
| The purpose of this submission is to add Ø5.5 mm and Ø7.0 mm headed | |
| cannulated screws to the Tiger Cannulated Screw System and to modify the | |
| indications for use statement for previously cleared devices (K081510 / | |
| K112737). | |
| Materials | Titanium alloy, Ti-6Al-4V (ASTM F136) |
| Substantial | |
| Equivalence Claimed | |
| to Predicate Devices | The Ø5.5 mm and Ø7.0 mm Tiger Cannulated Screws and Washers are |
| substantially equivalent to the predicate devices in terms of intended use, design, | |
| materials used, mechanical safety and performances. | |
| Indications for Use | The Tiger Cannulated Screw System is indicated for fixation of fractures, non- |
| unions, arthrodeses, and osteotomies of bones appropriate for the size of the | |
| device. | |
| Non-clinical Test | |
| Summary | The following analyses were conducted: |
| ASTM F543-07 | |
| • Torque to Failure | |
| • Axial Pullout Strength | |
| • Axial Pull Through Strength | |
| • Driving/Insertion and Removal Torque | |
| The results of these evaluations indicate that the Tiger Cannulated Screws are | |
| equivalent to predicate devices. | |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non- | |
| clinical and Clinical | Trilliant Surgical considers the Ø5.5 mm and Ø7.0 mm Tiger Cannulated Screws |
| and Washers to be equivalent to the predicate devices listed above. This | |
| conclusion is based upon the devices' similarities in principles of operation, | |
| technology, materials and indications for use |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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