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Hinge Pediatric Plating System

by Pega Medical, Inc.

510(k) K090440

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)SESE Substantially Equivalent · Traditional NumberK090440 Date20 May 2009ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Hinge Pediatric Plating System is an articulated plate and screw system designed to correct knee deformities in growing children through growth modulation. It is intended to fix pediatric mal-alignment through a less-invasive, gentle correction, with the goal of achieving ideal placement of a true hinge at the growth plate.

The device is supplied as part of a plating system and is intended for use in pediatric patients. Regulatory authorizations include FDA 510(k) clearance, with the submission reviewed by the Orthopedic (OR) advisory committee. The device is not specified as single-use or reusable, and storage requirements are not detailed in the provided data.

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Questions

AI-generated answers, 25 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 is the Hinge Pediatric Plating System used for?

    This system is designed to correct knee deformities in growing children. It works by gently correcting pediatric mal-alignment to achieve ideal placement of a true hinge at the growth plate.

  • How is the device supplied?

    The device is supplied as part of a plating system. It is intended for use in pediatric patients.

  • What regulatory authorizations does it have?

    The Hinge Pediatric Plating System has FDA 510(k) clearance. The submission was reviewed by the Orthopedic (OR) advisory committee.

  • Is the device intended for single use?

    The provided data does not specify whether the device is intended for single use or reuse.

  • What are the storage requirements for the device?

    The provided data does not include specific storage requirements for the Hinge Pediatric Plating System.