(67 days)
Not Found
No
The 510(k) summary describes a system of screws and instruments for bone fixation, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device, the Tiger Cannulated Screw Fixation System, is described as implants (screws) intended for fixation of fractures, non-unions, arthrodeses, and osteotomies of the small bones in the hand and foot. This direct therapeutic action (fixation) for medical conditions fulfills the definition of a therapeutic device.
No
Explanation: The device description states it is a "Cannulated Screw System" comprised of screws and instruments for "bone fixation of the hand and foot". This indicates a therapeutic or surgical purpose, not a diagnostic one.
No
The device description explicitly states it is comprised of screws and instruments, which are physical hardware components, 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: The Tiger Cannulated Screw Fixation System is a system of implants (screws) and instruments used for the fixation of bones within the hand and foot. This is a surgical device used within the body, not for testing samples outside the body.
- Intended Use: The intended use is for the fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones In the hand and foot. This is a therapeutic and structural purpose, not a diagnostic one.
The information provided clearly describes a surgical implant system, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The Tiger Cannulated Screw Fixation System implants (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
The Tiger Cannulated Screw System is comprised of screws used for bone fixation of the hand and foot following trauma or osteotomy. The system features 2.0mm diameter, 2.4mm diameter, 3.0mm diameter and 4.0mm diameter cannulated screws. System instruments include 2.0mm/2.4mm drill bit, countersink, driver, 3.0mm/4.0mm drill bit, countersink, driver, screw driver handle, depth gauge, screw remover and K-wires to facilitate the placement of screws.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
The Tiger Cannulated Screw System is substantially equivalent to similar previously cleared cannulated screws. (Exact K/DEN not explicitly stated in the document).
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 Cannulated Screw System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Tiger Cannulated Screw System.
Date Prepared: May 27, 2008
AUG - 4 2008
| 1. Submitter: | Contact Person: | A |
|---|---|---|
| Trilliant Surgical Ltd | ||
| 1630 W.13th St | ||
| Houston, TX 77008 | J.D. Webb | |
| The OrthoMedix Group, Inc. | ||
| 1001 Oakwood Blvd | ||
| Round Rock, TX 78681 | ||
| Telephone: 512-388-0199 |
| 2. Trade name: | Tiger Cannulated Screw System |
|---|---|
| Common Name: | Bone screw |
| Classification Name: | Screw, Fixation, Bone |
| Class II per 21 CFR section 888.3040 | |
| HWC |
3. Predicate or legally marketed devices which are substantially equivalent:
The Tiger Cannulated Screw System is substantially equivalent to similar previously cleared cannulated screws.
4. Description of the device:
The Tiger Cannulated Screw System is comprised of screws used for bone fixation of the hand and foot following trauma or osteotomy. The system features 2.0mm diameter, 2.4mm diameter, 3.0mm diameter and 4.0mm diameter cannulated screws. System instruments include 2.0mm/2.4mm drill bit, countersink, driver, 3.0mm/4.0mm drill bit, countersink, driver, screw driver handle, depth gauge, screw remover and K-wires to facilitate the placement of screws.
Materials:
The screws will be manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136.
Function:
The Tiger Cannulated Screw Fixation System is comprised of screws used for bone fixation of the hand and foot following trauma or osteotomy.
5. Intended Use:
The Tiger Cannulated Screw Fixati on System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones In the hand and foot.
Comparison of the technological characteristics of the device to predicate and legally marketed 6. devices:
Due to the similarity of materials and design to both pre-enactment and post-enactment devices, Trilliant Surgical believes that the Tiger Cannulated Screw Fixation System does not raise any new safety or effectiveness issues and does not require any nonclinical testing.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Trillian Surgical Ltd. % The OrthoMedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
AUG - 4 2008
Re: K081510
Trade/Device Name: Tiger Cannulated Screw Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 27, 2008 Received: May 29, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
2
Page 2 - Mr. J.D. Webb
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millman
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): _K0815 | را | ر
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Tiger Cannulated Screw Fixation System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones In the hand and foot.
Prescription Use _ X (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)
Mark A. Wilkerson
Division of General, Restorative, and Neurological Devices
0815 510(k) Number