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Knowles Pin

by Onyx Medical Corp. 510(k)

Active United States

510(k) K903259

Overview

The Knowles Pin is an orthopedic fixation device classified under product code HWC, designed for internal fixation of fractures. It is a type of intramedullary pin used to stabilize long bone fractures by providing rigid alignment and support during the healing process.

This device is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K903259) with a traditional review pathway, classified as a Class II medical device. Storage and handling must comply with sterile instrument protocols, and its use is restricted to orthopedic surgical settings as indicated by its advisory committee classification.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SN Traditional NumberK903259 Date9 Aug 1990DecidedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SN

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Questions

  • What types of fractures is the Knowles Pin specifically designed to stabilize, and how does it work to support healing?

    The Knowles Pin is an intramedullary fixation device intended for stabilizing long bone fractures by providing rigid internal alignment and support. It is designed to be inserted into the medullary cavity of the bone, ensuring proper alignment during the healing process. This rigid fixation helps prevent movement at the fracture site, promoting stable bone union.

  • Is the Knowles Pin reusable, or is it meant for single-use only? How should it be stored to maintain sterility?

    The Knowles Pin is explicitly intended for single-use only. To maintain sterility, it must be stored and handled according to sterile instrument protocols, as it is supplied in a sterile condition. Proper storage ensures it remains uncontaminated until use in an orthopedic surgical setting.

  • What regulatory pathway was followed for FDA clearance of the Knowles Pin, and what does this mean for its use in clinical practice?

    The Knowles Pin received FDA clearance through a 510(k) submission (K903259) under the traditional review pathway, classified as a Class II medical device. This means it was determined to be substantially equivalent to a legally marketed device for some indications, and its use is restricted to orthopedic surgical applications as indicated by its advisory committee classification (OR—Orthopedic).

  • Are there different sizes or models of the Knowles Pin, and if so, how would a clinician determine the appropriate one for a patient?

    The provided data does not specify exact sizes or models of the Knowles Pin, but as an intramedullary fixation device for long bone fractures, its selection would typically depend on factors like bone diameter, fracture location, and surgeon preference. Clinicians would rely on manufacturer guidelines or intraoperative assessment to choose the most suitable pin size for proper fit and stability.