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Syntec-Taichung Non-Sterile Knowles Pin, Models: For Hexagonal Collar: 2991-01/…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K983757

by Syntec Scientific Corp.

Identifiers

510(k) Number
K983757 FDA 510(k)
FDA Product Code
JDW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Syntec-Taichung Non-Sterile Knowles Pin is an orthopedic device available in models for hexagonal collar (2991-01/15, 2992-01/15) and square collar (29992-01). It is designed for use in orthopedic procedures, though the specific indications are not provided in the device data.

This device is non-sterile and supplied as a single-use or reusable product (not specified). It is not indicated for MRI use. The device is authorized under FDA 510K clearance with product code JDW and was received by the FDA on 1998-10-23, with a decision date of 1998-12-04.

Frequently asked questions

What types of orthopedic procedures is this Knowles Pin designed for, and how do I know which model to choose?

The Syntec-Taichung Knowles Pin is designed for orthopedic applications, though the exact clinical indications are not specified in the device data. The device comes in two collar types: hexagonal (models 2991-01/15 and 2992-01/15) and square (29992-01). The choice depends on the surgical requirements—hexagonal collars may offer better torque stability, while square collars may fit specific implant designs. Confirm compatibility with your surgical plan or implant system before use.

Is this pin sterile, and if not, how should it be handled in the operating room?

The Syntec-Taichung Knowles Pin is explicitly labeled as non-sterile. For use in surgery, it must be sterilized by the facility prior to implantation, following standard protocols for orthopedic hardware (e.g., ethylene oxide, autoclave, or gamma irradiation). Always verify sterility validation before use, as improper handling risks contamination.

Can this pin be reused, or is it intended for single-use only?

The device data does not explicitly state whether the Knowles Pin is reusable or single-use. However, orthopedic pins are typically designed for single-use to ensure patient safety and sterility. If reuse is considered, the facility must validate cleaning, sterilization, and inspection processes to meet regulatory standards. Consult your facility’s infection control protocols for guidance.

What storage conditions should I follow for these pins?

While specific storage instructions aren’t detailed, non-sterile orthopedic devices like this pin should be stored in a clean, dry environment protected from moisture, dust, and physical damage. Avoid extreme temperatures or direct sunlight. If sterilized for use, follow the manufacturer’s post-sterilization storage guidelines to maintain integrity until implantation.

How do I confirm this device meets FDA requirements for orthopedic hardware?

This pin holds an FDA 510(k) clearance (K983757) under product code JDW, with a decision date of December 4, 1998. The clearance indicates it was deemed substantially equivalent to a legally marketed predicate device for orthopedic use. For purchasing or clinical use, verify the lot/serial number against the manufacturer’s records to ensure compliance with the approved submission. The advisory committee (OR) and traditional clearance route are noted for reference.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Syntec Scientific Corp.

Sources (1)

  • FDA 510(k) K983757 24 fields · synced Sep 19, 2026