(42 days)
The Knowles Pin is provided non-sterile. The device may be used for bone reconstruction, for reducible intracapsular fracture of the femoral neck and to moderate slipped upper femoral epiphyses.
The Knowles Pin is partially threaded wires machined with a trocar point. The threads engage in cancellous and subchondral bone of the femoral head. The distal portion of the pin is broken off at the scored line following fracture fixation. The Knowles Pin is divided two kinds of styles: square and hexagonal collar. The standard Knowles Pin is a hexagonal collar, a thread length ranges from 1.25 inches (32 mm) to 3 inches (76 mm), and a thread diameter of 4.0 and 4.8 mm. Another pin has a square collar, both a thread length and thread diameter is the same as hexagonal collar.
This document is a 510(k) summary for a medical device called the "Syntec-Taichung Non-sterile Knowles Pin," used for bone fixation. It does not contain information about acceptance criteria or a study proving the device meets those criteria.
The provided text focuses on:
- Device Description: Material, styles (square and hexagonal collar), dimensions.
- Indication for Use: Bone reconstruction, reducible intracapsular femoral neck fractures, and moderate slipped upper femoral epiphyses.
- Regulatory Information: Classification as Class II, product code JDW, and the FDA's clearance of the 510(k) submission.
There is no mention of any performance metrics, studies, or acceptance criteria within the provided text. Therefore, I cannot generate the requested table or answer questions related to study design, sample sizes, ground truth, or expert involvement. The document primarily serves as a regulatory clearance document rather than a performance evaluation report.
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510(k) Summary of Safety and effectiveness
- 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
- Proprietary Name : Syntec-Taichung Non-sterile Knowles Pin >
- Common Name : Bone Fixation Pin ♪
-
Classification Status : Class II, CFR 888.3040
- ア Device Product Code : 87 JDW
- Material: This device is manufactured from commercially 316 LS stainless steel. >
> Indication for Use :
The Knowles Pin is provided non-sterile. The device may be used for bone reconstruction, for reducible intracapsular fracture of the femoral neck and to moderate slipped upper femoral epiphyses.
A Description of the Device :
The Knowles Pin is partially threaded wires machined with a trocar point. The threads engage in cancellous and subchondral bone of the femoral head. The distal portion of the pin is broken off at the scored line following fracture fixation.
The Knowles Pin is divided two kinds of styles: square and hexagonal collar. The standard Knowles Pin is a hexagonal collar, a thread length ranges from 1.25 inches (32 mm) to 3 inches (76 mm), and a thread diameter of 4.0 and 4.8 mm. Another pin has a square collar, both a thread length and thread diameter is the same as hexagonal collar.
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Rockville MD 20850
Image /page/1/Picture/2 description: The image shows the text "Food and Drug Administration" followed by the address "9200 Corporate Boulevard". The text is black and the background is white. The text is centered on the image.
4 1998 DEC
Mr. Ted Y. Shi President Syntec-Taichung Medical Instruments Company Limited 2,Kung San Road, Chaun Shing Industrial Zone, Shen Kang Chang Hua, Taiwan 509
Re: K983757 Syntec-Taichung Non-sterile Knowles Pin Regulatory Class: II Product Code: JDW Dated: October 19, 1998 Received: October 23, 1998
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 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 895. A 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 regulation (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 requlatory action. In addition, FDA may publish further announcements 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 requlations.
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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 regulation (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 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general 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,
f Cella 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 1 of 1
510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for use:
The Knowles Pin is provided non-sterile. The device may be used for bone reconstruction, for reducible intracapsular fracture of the femoral neck and to moderate i slipped upper femoral epiphyses.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
i
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter-Use | |
|---|---|
| (Optional Format 1-2-96) |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | KB3757 |
§ 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.