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Piccolo Composite Plate System

by Carbofix Orthopedics Ltd 3 variants

510(k) K143496

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) NumberK143496 Date29 May 2015IssuedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HRS
FDA applicant
CarboFix Orthopedics , Ltd.
Device class
Class II
Regulation
21 CFR Part 888.3030
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Piccolo Composite Plate System is a composite orthopedic fixation device designed for internal fixation of long bone fractures. It combines a titanium alloy plate with a composite material to provide rigid stabilization, facilitating bone healing while minimizing stress shielding effects.

This system is intended for use in orthopedic surgery settings and is supplied sterile for single-use. The plates are available in various sizes and configurations to accommodate different anatomical requirements. Authorized for use under FDA 510(k) clearance (K130061), it adheres to orthopedic fixation standards and is classified under product code HRS.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of long bone fractures is the Piccolo Composite Plate System designed to stabilize, and how does its composite design benefit healing?

    The Piccolo Composite Plate System is designed for internal fixation of long bone fractures, providing rigid stabilization to support bone healing. Its composite design—combining a titanium alloy plate with a composite material—helps reduce stress shielding, a common issue with traditional metal plates where the bone may weaken due to uneven load distribution. This design aims to maintain natural bone loading while ensuring secure fixation.

  • Is the Piccolo Composite Plate System intended for reuse in clinical settings, or is it meant to be used only once?

    The Piccolo Composite Plate System is supplied sterile and explicitly intended for single-use only. Reuse is not recommended or supported by the manufacturer, as single-use ensures patient safety and sterility standards are maintained.

  • What sizes and configurations are available for the Piccolo Composite Plate System, and how does this accommodate different anatomical needs?

    The Piccolo Composite Plate System comes in various sizes and configurations to match different anatomical requirements for long bone fixation. While exact dimensions are not specified, the modular design allows for customization to fit specific fracture patterns and bone types, ensuring adaptability in orthopedic procedures.

  • How should the Piccolo Composite Plate System be stored, and are there any special handling instructions to maintain its integrity?

    Since the system is supplied sterile, it should be stored in its original packaging until ready for use to preserve sterility. The manufacturer likely recommends keeping it in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow the included instructions for storage and handling to ensure the device remains uncontaminated and functional.