(110 days)
Not Found
No
The device description focuses solely on the mechanical properties and materials of bone screws, with no mention of software, algorithms, or data processing.
No
The device is indicated for fracture fixation, meaning it is used to stabilize broken bones, not to provide therapy.
No
The device is described as a system for "fracture fixation," indicating it is a therapeutic device used to treat fractures rather than diagnose them. Its components are surgical screws.
No
The device description clearly describes physical hardware components (cannulated titanium compression screws) and their material composition. There is no mention of software as the primary or sole component.
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 TriMed Omnitech Large System is described as a system of screws used for fracture fixation of bones. This is a surgical implant, not a device that analyzes biological samples.
- Intended Use: The intended use is for "fracture fixation," which is a surgical procedure to stabilize broken bones. This is a therapeutic intervention, not a diagnostic test.
The information provided clearly indicates this is a surgical implant used for treating bone fractures, which falls under the category of a surgical device or orthopedic implant, not an IVD.
N/A
Intended Use / Indications for Use
The TriMed Omnitech Large System is indicated for fracture fixation of large bone and large bone fragments, as well as fractures of the calcaneus, talus, and pelvis.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HTY
Device Description
The Omnitech Large screws are cannulated titanium compression screws available in diameters of 4.5 mm and 7.3 mm. The screws utilize two different thread pitches allowing the distal fragment to be drawn towards the proximal fragment with each turn of the screw. The conical shaped head increases the surface contact area with the cortical bone avoiding piercing of the cortical bone and the subsequent loss of compression. Currently the screws are made of TA6V ELI titanium alloy. Surgical grade stainless steel screws complying with ASTM F138 may be made available in the future.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large bone, large bone fragments, calcaneus, talus, pelvis
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)
Not Found
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.
K993106/K060736, K962011, K963172
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.
0
MAR ] 7 2010
510(K) Summary of Safety and Effectiveness TRIMED OMNITECH LARGE SYSTEM
| Submitted By: | TriMed, Inc. |
|---|---|
| 25864 Tournament Road, Ste. A | |
| Valencia, CA 91355 | |
| (800)633-7221 | |
| Registration #: | 2031009 |
| Manufactured By: | Biotech International |
| 305, allée de Craponne | |
| 13300 Salon De Provence | |
| France | |
| Registration#: | 3005270144 |
| Prepared By/Contact Person: | Kelli Anderson |
| Phone: (661)312-7150 | |
| Fax: (661)254-8485 | |
| Proprietary Name: | Omnitech Large or TriMed Compression |
| Screw | |
| Classification: | Class II: Bone, Fixation, Screws |
| HWC - Section 888.3040 | |
| Class II: Pin, Fixation, Smooth | |
| HTY - Section 888.3040 | |
| Summary Preparation Date: | March 10, 2010 |
I. Indications for Use:
. "
ﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
The TriMed Omnitech Large System is indicated for fracture fixation of large bone and large bone fragments, as well as fractures of the calcaneus, talus, and pelvis.
1
Device Description: II.
:"小
The Omnitech Large screws are cannulated titanium compression screws available in diameters of 4.5 mm and 7.3 mm. The screws utilize two different thread pitches allowing the distal fragment to be drawn towards the proximal fragment with each turn of the screw. The conical shaped head increases the surface contact area with the cortical bone avoiding piercing of the cortical bone and the subsequent loss of compression. Currently the screws are made of TA6V ELI titanium alloy. Surgical grade stainless steel screws complying with ASTM F138 may be made available in the future.
III. Substantial Equivalence:
K993106/K060736 - Smith & Nephew, Smith & Nephew Bone Plate System K962011- Synthes (USA), Synthes 7.0/7.3 mm Cannulated Screws K963172 - Synthes (USA), Synthes 4.5 mm Cannulated Screw
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three wing-like strokes, positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
TriMed. Inc. % Ms. Kelli Anderson Regulatory Affairs Consultant 25864 Tournament Road, Suite A Valencia, California 91355
MAR 1 7 2010
Re: K093676
Trade/Device Name: TriMed Omnitech Large System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, HTY Dated: February 17, 2010 Received: February 22, 2010
Dear Ms. Anderson:
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. Ilsting 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
3
Page 2 - Ms. Kelli Anderson
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/ucm115809.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 vours.
Qarban Buehno
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):___K093676
Device Name:__________________________________________________________________________________________________________________________________________________________________
The TriMed Omnitech Large System is indicated for fracture fixation of large bone and large bone fragments, as well as fractures of the calcaneus, talus, and pelvis.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sarta for mxm
(Division Sign-Off)
(Division Sign-Off Division of Surgical. Orthopedic, and Restorative Devices
510(k) Number K093676
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