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Free Gliding Slipped Capital Femoral Epiphysis Screw (SCFE)

by Pega Medical, Inc.

510(k) K131591

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK131591 Date27 Nov 2013ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0324-2016 FDA Class II initiated 20 Oct 2015

    SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.

    • Terminated Z-1848-2015 FDA Class II initiated 15 Jun 2015

    SCFE Drivers of the Free-Gliding SCFE Screw System are recalled because the handle of the instruments may detach from the shaft if high torques are applied in counter-clockwise rotation.

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  • Withdrawn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
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 Free Gliding Slipped Capital Femoral Epiphysis Screw (SCFE) is a self-extending, cannulated orthopedic implant designed for the fixation of slipped capital femoral epiphysis. Classified under orthopedic device nomenclature, it stabilizes the femoral head and neck junction in pediatric patients with open growth plates, preventing further slippage while preserving normal proximal femur development. The device consists of modular components—male, female, and cap—that interlock via threaded fixation to maintain alignment.

This screw system is supplied as a sterile, single-use device intended for surgical use in orthopedic settings. It is intended for use in patients with slipped capital femoral epiphysis or femoral neck fractures, as authorized under FDA 510(k) clearance (K131591). The modular design allows for precise placement and fixation without compromising growth plate integrity. Storage and handling must comply with sterile surgical instrument protocols, and sizing is tailored to pediatric anatomy.

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Questions

AI-generated answers, 20 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 patients is this screw designed to treat, and why is the modular design important for them?

    This screw is specifically designed for pediatric patients with open growth plates who have slipped capital femoral epiphysis (SCFE) or femoral neck fractures. The modular design—comprising male, female, and cap components—allows for precise, customizable placement without damaging the growth plate, ensuring stability while preserving normal femoral development.

  • Is this device reusable, and if not, how should it be handled to maintain sterility?

    No, this device is a single-use implant intended for surgical use only. Since it is supplied sterile, it must be handled using strict sterile surgical protocols to prevent contamination before and during implantation. Follow standard sterile instrument handling guidelines to ensure integrity.

  • What sizes or models are available, and how does the sizing relate to pediatric anatomy?

    The device is tailored to pediatric anatomy, though exact sizes or model variants aren’t specified in the data. The modular design allows for adjustable fixation, accommodating varying femoral head and neck dimensions in young patients with open growth plates. Sizing is likely determined intraoperatively based on the patient’s anatomy.

  • How is this screw different from traditional SCFE fixation methods, and what advantages does the 'free gliding' feature provide?

    Unlike traditional screws, this system uses a self-extending, cannulated design with modular interlocking components, which allows for precise alignment without over-tightening. The 'free gliding' feature likely reduces stress on the growth plate, minimizing the risk of growth disturbances while maintaining stability—critical for preserving long-term femoral development in pediatric patients.