(70 days)
Richards - Trimax Nail System
Not Found
No
The description focuses solely on the mechanical design and features of a bone fixation system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as an implant used for fixation of fractures, which falls under orthopedic surgical devices. While it aids in healing, it is not a therapeutic device in the sense of delivering treatment like drugs, radiation, or specific therapies, but rather a mechanical support.
No
The device is an "Interlocking Nail System" designed for the fixation of fractures in long bones. Its purpose is therapeutic (to repair fractures), not to diagnose a condition or disease.
No
The device description clearly details physical implants (nails and screws) made of metal, 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 clearly stated as "for the fixation of fractures" by being inserted into the bone. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details implants (nails and screws) designed for mechanical support within the bone. This is consistent with a surgical implant, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) from the human body to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are used in vitro (outside the body) to examine specimens. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Interlocking Nail System is provided non-sterile. The implants are inserted into the medullary(bone marrow) canal of long bones(humerus, femur, and tibia) for the fixation of fractures.
Product codes (comma separated list FDA assigned to the subject device)
87 HSB
Device Description
The interlocking system makes up of Humeral, Fibial Nail and bolt screws. The bolt screws are utilized with the different interlocking nails have the same features such as:
- Proximal locking: Choice of two oval holes for static locking(only three holes for humerus) secures the rotational and axial stability.
- Anatomical design:
- Humerus: The curvature of 5° in the upper third of the Reamed Humeral Nail allows for easy insertion and good anatomical fit.
- Femur: The 1.88m radius of the Reamed Femoral Nail corresponds closely with the average anatomical curvature of the femur.
- Tibia: The curvature of 15° in the upper third of the Reamed Tibial Nail allows for easy insertion and good anatomical fit.
- Distal locking: Through two medial holes, additional locking is also possible in the anatomical seat.
- Easy insertion: The curvature of the posterior aspect of the nail reduces damage to the interior posterior cortical surface during insertion.
The dimension of the interlocking nail ranges in diameter from 7 to 16 mm and total length 200 to 480 mm.
The locking bolt screws have high strength, no tapping necessary and easy locking technique. The dimension of the bolt screw ranges in thread diameter from 3.9 to 6.4 mm and total length 20 to 100 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
medullary(bone marrow) canal of long bones(humerus, femur, and tibia)
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.
Richards - Trimax Nail System
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
510(k) Summary of Safety and effectiveness
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Sponsor: Syntec-Taichung Medical Instruments Co., Ltd. > 2, Kung San Road, Chuan Shing Industrial Zone, Shen Kang, Chang Hua, Taiwan. 509 Phone / FAX: 886-4-7987099 / 886-4-7987077 Contact Person: Ted Y. Shi
984543 -
Proprietary Name : Syntec-Taichung Non-sterile Interlocking Nail System A
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A Common Name : Various Types of Intramedullary Fixation Implants
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Classification Status : Class II, CFR 888.3020
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Device Product Code : 87 HSB A
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A Material: This device is manufactured from commercially 316LS stainless steel.
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A Indication for Use :
The Interlocking Nail System is provided non-sterile. The implants are inserted into the medullary(bone marrow) canal of long bones(humerus, femur, and tibia) for the fixation of fractures.
Description of the Device : A
The interlocking system makes up of Humeral, Fibial Nail and bolt screws. The bolt screws are utilized with the different interlocking nails have the same features such as:
- A Proximal locking: Choice of two oval holes for static locking(only three holes for humerus) secures the rotational and axial stability.
- A Anatomical design:
- Humerus: The curvature of 5° in the upper third of the Reamed Humeral Nail � allows for easy insertion and good anatomical fit.
- Femur: The 1.88m radius of the Reamed Femoral Nail corresponds closely � with the average anatomical curvature of the femur.
- � Tibia: The curvature of 15° in the upper third of the Reamed Tibial Nail allows for easy insertion and good anatomical fit.
1
- Distal locking: Through two medial holes, additional locking is also possible in the > anatomical seat.
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Easy insertion: The curvature of the posterior aspect of the nail reduces damage to the interior posterior cortical surface during insertion.
The dimension of the interlocking nail ranges in diameter from 7 to 16 mm and total length 200 to 480 mm.
The locking bolt screws have high strength, no tapping necessary and easy locking technique. The dimension of the bolt screw ranges in thread diameter from 3.9 to 6.4 mm and total length 20 to 100 mm.
> Basis of Substantial Equivalence :
A comparison of the non-sterile Interlocking Nail System described in this submission and Richards - Trimax Nail System has been commercial device that they are very similar or identical in terms of design, sizes, material and appliance. Based on this information, Syntec-Taichung (Taiwan) believes that the non-sterile Interlocking Nail System is substantially equivalent to Richards - Trimax Nail System.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 1 1999
Mr. Ted Y. Shi President Syntec-Taichung Medical Instruments Company Limited 2, Kung San Road, Chuan Shing Industrial Zone Shen Kang, Chang Hua, Taiwan 509
K984543 Re: Syntec-Taichung (Taiwan) Non-sterile Interlocking Nail System Requlatory Class: II нав Product Code: December 15, 1998 Dated: December 21, 1998 Received:
Dear Mr. Shi:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 (Premarket Approval), it may Existing major be subject to such additional controls. requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Ted Y. Shi
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact Also, please note the Office of Compliance at (301) 594-4639. the regulation entitled, "Misbranding by reference to Other general premarket notification" (21 CFR 807.97). information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page __ of ___________________________________________________________________________________________________________________________________________________________________
510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for use:
The Interlocking Nail System is provided non-sterile. The implants are inserted into the medullary(bone marrow) canal of long bones(humerus, femur, and tibia) for the fixation of fractures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |||
|---|---|---|---|
| Prescription Use | + | OR | Over-The-Counter-Use_ |
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) | ||
| (Division Sign-Off) | |||
| Division of General Restorative Devices | |||
| 510(k) Number | K984543 |