(258 days)
Not Found
No
The device description and intended use are for a mechanical bone screw, and there is no mention of AI, ML, image processing, or data analysis capabilities.
No.
The device description indicates it is a bone screw made of stainless steel for fracture fixation and reconstruction, which is a physical implant rather than a therapeutic device that delivers therapy or treatment.
No
The device is described as a surgical implant (bone screw) used for fracture repair and fixation, not for diagnosing conditions. Its intended use focuses on treatment and reconstruction.
No
The device description explicitly states the device consists of "screws made of medic 11 grade 3 16L stainless steel," indicating it is a physical implant, 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 examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Trauson Bone Screw Function: The provided description clearly states the Trauson Bone Screw is an implantable device used for the physical fixation and repair of bones. It is surgically inserted into the body.
- No Specimen Analysis: There is no mention of the device analyzing any biological specimens outside of the body.
The description focuses on the mechanical properties and surgical application of the screw, which is characteristic of a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
Trauson Bone Screw is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
Product codes
HWC
Device Description
The applicant device of Trauson Bone Screw consists of screws made of medic 11 grade 3 16L stainless steel that meet ASTM 138 is intended for fixation of fractures, fusions, or osteotomies of bones of the hand and foot. The screws are Type HA with spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head.
The applicant devices are not sterile. No new materials are used in the development of this implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones of the 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)
Bench tests of the applicant device are conducted to determine the Torsional properties, Insertion Torque, Pullout Test, please see the Appendix 2, ASTM Test Report
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
K073159 #1/3
Appendix I. 510(k) Summary
JUL 2 3 2008
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The Assigned 510(k) Number is:
- Applicant Device Information Trade/Proprietary Name: Trauson Bone Screw Common Name: Smooth or threaded metallic bone fixation fastener Classification Name: Screw, fixation, bone Device Class: II Product Code: HWC Regulation Number: 888.3040 Intended Use:
Trauson Bone Screw is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
2. Submitter Information
Establishment Registration Name:
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD. 31 Houcun Road, Niutang Town Changzhou, Jiangsu, CHINA 213163 Phone: +86-757-86280075 Fax: +86-757-86397179
Contact Person of the Submission:
Ms. Diana Hong Mr. Eric. Chen Shanghai Mid-link Consulting Co., Ltd. 5300 Playa Vista Drive, Unit 15 Los Angeles, CA 90094, USA Phone: +86-21-64264467 x 152 Fax: +86-21-64264468 x 809 Email: Diana.hong@mid-link.net &: Eric.chen@mid-link.net
1
K073159 #2/3
Premarket Notification 510(k) Submission-510(k) Summary Report No .: A20060011
- Predicate Device K-number: K060071 Device Name: Nexa Compression Screw Device Trade Name: Nexa Compression Screw
Manufactured by:
Nexa Orthopedics, Inc., (dba Futura Biomedical, LLC) 10675 Sorrento Valley Road, Suite 1 00 San Diego, CA 92121
4. Device Description
The applicant device of Trauson Bone Screw consists of screws made of medic 11 grade 3 16L stainless steel that meet ASTM 138 is intended for fixation of fractures, fusions, or osteotomies of bones of the hand and foot. The screws are Type HA with spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head.
The applicant devices are not sterile. No new materials are used in the development of this implant.
2
K073159 * 3/3
Premarket Notification 510(k) Submission-510(k) Summary Report No .: A20060011
5. Test Data
The applicant device material only contains Medic 11 grade 3 16L stainless steel that meets ASTM 138, and the material is medical grade and widely used in the industry which requires no biocompatibility testing.
However, the all conducted Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices". The compatibility of all the component material in the finished product was provided.
Bench tests of the applicant device are conducted to determine the Torsional properties, Insertion Torque, Pullout Test, please see the Appendix 2, ASTM Test Report
Substantially Equivalence 6.
Comparison Analysis:
The Applicant device has the same classification information, intended use, sterilization specifications, performance, biocompatibility, chemical specifications and similar physical and mechanical specifications with the predicate device. The only difference between applicant device and predicate device is some physical specifications variant which is too slight to influence the effectiveness and safety. No new question was raised.
Conclusion:
The applicant device is Substantially Equivalent (SE) to the predicate device in terms of Effectiveness and Safety.
3
Image /page/3/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 2008
Trauson (Jiangsu) Medical Instrument Co., LTD. % Diana Hong Lane 999, Ahongshan No. 2 Road Suite 8D, No. 19 Shanghai, China 200030
Re: K073159
Trade/Device Name: Trauson Bone Screw, Models HA 3.5 and 4.5 Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: July 21, 2008 Reccived: July 22, 2008
Dear Ms. Hong:
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 Kegulations, 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.
4
Page 2 - Ms. Diana Hong
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 its toll-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliman
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Appendix II. Indications for Use
510(k) Number: K073159
Device Name: Trauson Bone Screw
Indications for Use:
Trauson Bone Screw is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature of
Witness
(Division Sign-Off) (Division Digiston of General, Restorative, and Neurological Devices of of 1 Page
510(k) Number