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Biopro K-Wire Models 16863, 17231, 17232, 18577, 18682-18685

FDA 510(k)

Class II (US FDA 510(k))

510(k) K083490

by Biopro, Inc.

Identifiers

510(k) Number
K083490 FDA 510(k)
FDA Product Code
HTY FDA 510(k)
Models / Variants
16863 FDA 510(k)
17231 FDA 510(k)
17232 FDA 510(k)
18577 FDA 510(k)
18682-18685 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 Biopro K-Wire is a metallic bone fixation fastener designed for orthopedic applications. It is used by surgeons to stabilize bone fractures, facilitate bone reconstructions, and serve as a guide pin for secondary implant placement.

This device has received FDA 510(k) clearance. It is available in multiple models, including 16863, 17231, 17232, 18577, and 18682-18685.

Frequently asked questions

What is the primary clinical purpose of the Biopro K-Wire?

The Biopro K-Wire is a metallic bone fixation fastener intended for orthopedic surgical applications. It is specifically used to stabilize bone fractures, assist in bone reconstruction procedures, and function as a guide pin to facilitate the accurate placement of secondary implants.

Which specific models are included in this product line?

This device is available in a range of configurations to suit various orthopedic needs, specifically including models 16863, 17231, 17232, 18577, and the series 18682 through 18685.

What is the regulatory status of the Biopro K-Wire?

The Biopro K-Wire has received FDA 510(k) clearance. It was reviewed under the orthopedic advisory committee and determined to be substantially equivalent to existing devices, allowing it to be marketed for its intended surgical use.

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. Sources consulted: Biopro K-wire, Models 16863, 17231, 17232, 18577, 18682-18685, Biopro K-wire, Models 16863, 17231, 17232, 18577, 18682-18685, Biopro K-wire, Models 16863, 17231, 17232, 18577, 18682-18685, "K-WIRE THREADED .062""" 18577 GUDID Device - FDA.report, Biopro, Inc. FDA 510 (k) Products (1987-2017)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biopro, Inc.

Sources (1)

  • FDA 510(k) K083490 24 fields · synced Oct 6, 2026