(277 days)
Not Found
No
The device description focuses on the mechanical properties and design of bone plates and screws, with no mention of AI or ML capabilities.
No
The device is described as an osteo-plate and screw fixation system for fracture fixation, which is a structural support device rather than a device intended to treat or cure a disease or medical condition.
No
The device is described as a fixation system (plates and screws) for fracture fixation, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly details physical components (plates and screws) made of specific materials and dimensions, indicating a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the Syntec Osteo-plate and screw Fixation is a device used for fracture fixation on bones. It is a physical implant used to stabilize broken bones.
- Intended Use: The intended use is to fix fractures in various bones of the body. This is a surgical procedure performed directly on the patient, not a test performed on a sample outside the body.
The information provided describes a surgical implant, not a diagnostic test performed on a biological sample.
N/A
Intended Use / Indications for Use
Syntec Osteo-plate and screw Fixation is intended to be used on small bones or large bones for fracture fixation, including the fractures of clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and small bones (metacarpals, metatarsals, and phalanges).
Product codes
HWC, HRS
Device Description
The Syntec Osteo-plate and screw Fixation provides two materials, Stainless Steel and Titanium Alloy (Ti-6Al-4V) and commercially followed by ASTM F138, and ASTM F136.
Those are designed with various sizes of partially and fully threaded to satisfy with different kinds of fractures as using on small bones or large bones. The subject components are plates available in width from 3.8mm to 17.5mm, in total length from 15mm to 319mm and the hole numbers are 2 to 22 holes. The threads of the screws are available in diameters from 2.4mm to 7.3mm, and in length from 6mm to 180mm. Those screws have been designed for fitting on different symptoms of fractures and the plates have been designed to distribute for local anatomies and should be necessary to be used with its intended screws. Basically, the screws used to fasten plates onto bone, or, as lag screws, to hold together fragments of bone. We have totally the same kinds of the screws and plates as the predicate devices' functions, but with self-tapping or self-drilling to promote the operation efficiency. Besides this, we have another alternative screws and plates which are designed with locking head of the screws taken place with the traditional screw head, and threaded aside locking hole of the plates taken place with the aside plain hole of the plates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones or large bones, including the fractures of clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and small bones (metacarpals, metatarsals, and phalanges).
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
The test results of the Compression strength of plates and screws, Pull-out strength of screws, and Torsional strength of screws were compared to the results of the Syntec-Taichung Non-sterile Bone Plate and Screw implants and demonstrated substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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JUN 2 5 2010
510(K) SUMMARY
Submitter's name : Address :
Contact person :
Common name:
Produce Code :
Predicate device:
Name of the device :
Classification name :
Regulation Number :
Trade or proprietary name :
Syntec Scientific Corporation 2, Kung San Rd, Chuan Shing Industrial Zone, Shen Kang, Chang Hua, Taiwan Tel : 886-4-7987099 Fax: 886-4-7987077 Carol Chang Syntec Osteo-plate and screw Fixation Syntec Osteo-plate and screw Fixation bone plate and bone screw Smooth or threaded metallic bone fixation fastener. HWC, HRS 888.3030, 888.3040 II Syntec-Taichung Non-sterile Bone Plate and Screw Implants (K983495) August 01, 2009
Preparation of the date:
Material:
Class :
The Syntec Osteo-plate and screw Fixation provides two materials, Stainless Steel and Titanium Alloy (Ti-6Al-4V) and commercially followed by ASTM F138, and ASTM F136.
Description of the Device:
Those are designed with various sizes of partially and fully threaded to satisfy with different kinds of fractures as using on small bones or large bones. The subject components are plates available in width from 3.8mm to 17.5mm, in total length from 15mm to 319mm and the hole numbers are 2 to 22 holes. The threads of the screws are available in diameters from 2.4mm to 7.3mm, and in length from 6mm to 180mm. Those
1
K092889 #2/3
screws have been designed for fitting on different symptoms of fractures and the plates have been designed to distribute for local anatomies and should be necessary to be used with its intended screws. Basically, the screws used to fasten plates onto bone, or, as lag screws, to hold together fragments of bone. We have totally the same kinds of the screws and plates as the predicate devices' functions, but with self-tapping or self-drilling to promote the operation efficiency. Besides this, we have another alternative screws and plates which are designed with locking head of the screws taken place with the traditional screw head, and threaded aside locking hole of the plates taken place with the aside plain hole of the plates.
Indications for Use:
Syntec Osteo-plate and screw Fixation is intended to be used on small bones or large bones for fracture fixation, including the fractures of clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and small bones (metacarpals, metatarsals, and phalanges).
Technology Characteristics:
The design, materials and indications for use of the Osteo-plate and screw are equivalent to device previously approved for market in the United States.
| Predicate Device | Applicant | |
|---|---|---|
| Sponsor | Syntec Scientific Corporation | Syntec Scientific Corporation |
| Device name | Syntec-Taichung Non-sterile | |
| Bone Plate and Screw implants | Syntec Osteo-plate and screw | |
| Fixation | ||
| 510(k) number | K983495 | - |
| Regulation number/ | ||
| name/ class/ product | ||
| code | Class II §888.3030, 888.3040 | |
| Single/ Multiple component | ||
| metallic bone fixation | ||
| appliances and accessories/ | ||
| Smooth or threaded metallic | ||
| bone fixation fastener | ||
| HRS, HWC | Class II §888.3030, 888.3040 | |
| Smooth or threaded metallic bone | ||
| fixation fastener | ||
| HRS, HWC | ||
| Intended Use | The bone plates and screws are | |
| provided non-sterile. The | Syntec Osteo-plate and screw | |
| Fixation is intended to be used on |
Device Comparison Table:
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K092889 #3/3
| | devices are intended to treat
fractures of various bones,
including the clavicle, scapula,
pelvis, long bone (humerus,
ulna, radius, femur, tibia, and
fibula), and small bone
(metacarpals, metatarsals, and
phalanges). | mini, small bones or large bones
for fracture fixation, including the
fractures of clavicle, scapula,
pelvis, long bone (humerus, ulna,
radius, femur, tibia, and fibula),
and small bone (metacarpals,
metatarsals, and phalanges). |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Diameters of screws | From 1.5mm to 7.3mm | From 2.4mm to 7.3mm |
| Lengths of plates | From 17mm to 262mm | From 15mm to 319mm |
| Materials | Stainless steel and
titanium alloy (Ti-6Al-4V) | Stainless steel and
titanium alloy (Ti-6Al-4V) |
Performance Data:
The test results of the Compression strength of plates and screws, Pull-out strength of screws, and Torsional strength of screws were compared to the results of the Syntec-Taichung Non-sterile Bone Plate and Screw implants and demonstrated substantial equivalence.
Conclusion:
The Syntec Osteo-plate and screw Fixation is no new issue of safety or effectiveness. The device does not additional concerns regarding safety and effectiveness and may, therefore, be considered substantially equivalent to the predicate device.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of flowing lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JUN 2 6 2010
Syntec Scientific Corporation % Ms. Carol Chang 3F1. 96 Chung Hsiao E. Rd. Sec. 3 Taipei China (Taiwan) 106
Re: K092889
Trade/Device Name: Syntec Osteo-plate and screw Fixation Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: June 10, 2010 Received: June 15, 2010
Dear Ms. Chang:
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 Part 801); medica! device reporting (reporting of medical
4
Page 2 - Ms. Carol Chang
device-related adverse events) (21 CFR 803); 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.
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 yours,
Mark N. Melke Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE
Indications for Use
510(k) Number (if known): K092889 Device Name: Syntec Osteo-plate and screw Fixation Indications for Use:
Syntec Osteo-plate and screw Fixation is intended to be used on small bones or large bones for fracture fixation, including the fractures of clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and small bones (metacarpals, metatarsals, and phalanges).
Prescription Use _____________________________ AND/OR Over-The-Counter Use_ ( Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Smuta for mxin
Division Sign-Q Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092889