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The Simple Locking IntraMedullary (SLIM) System

by Pega Medical, Inc. 2 variants

510(k) K143355

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK143355 Date10 Jul 2015ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2278-2019 FDA Class II initiated 29 May 2019

    Handle could jam with the Driver due to the detachment of an internal Connector Ring.

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  • Withdrawn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
HSB
Device Class
Class II
Regulation
21 CFR Part 888.3020
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Simple Locking IntraMedullary (SLIM) System is an intramedullary fixation rod designed for use in long bones. It consists of a solid shaft with a beveled point and is available in pre-determined or blank length options to facilitate insertion into the medullary canal.

The system is intended for alignment, stabilization, and fixation of long bones in pediatric patients to correct deformities or fractures. It is supplied as a non-sterile, reusable device and has received FDA 510(k) clearance under K143355 with product code HSB and regulatory classification as Class II.

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Questions

AI-generated answers, 27 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 Simple Locking IntraMedullary (SLIM) System used for?

    The SLIM System is intended for alignment, stabilization, and fixation of long bones in pediatric patients to correct deformities or fractures, as it is designed as an intramedullary fixation rod for use in long bones.

  • How is the SLIM System supplied and is it sterile or reusable?

    The SLIM System is supplied as a non-sterile, reusable device, meaning it is not provided in a sterile condition and is intended for multiple uses after appropriate reprocessing by the healthcare facility.

  • What length options are available for the SLIM System?

    The SLIM System is available in pre-determined or blank length options to facilitate insertion into the medullary canal, allowing flexibility in surgical planning based on patient anatomy.

  • What regulatory pathway was used for the SLIM System?

    The SLIM System received FDA 510(k) clearance under K143355, indicating it was found substantially equivalent to a legally marketed predicate device through the traditional 510(k) submission process.