# K131591: Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe)

- Pathway: 510(k) (Traditional)
- Applicant: Pega Medical, Inc.
- Decided: Nov 27, 2013 after 180 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K903810 (1990). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 2.
- K964893: Hansson Pin System, Osteonics Corp. (1997) Summary page 2.
- K033968: Hansson Pin System, Howmedica Osteonics Corp. (2004) Summary page 2.
- K092189: Pogo Screw, Fxdevices (2009) Summary page 2.
- K080649: Pogo Screw, Fxdevices (2008) Summary page 2.

## Recalls of this device
- Oct 20, 2015 · Class II · Z-0324-2016: SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.
- Jun 15, 2015 · Class II · Z-1848-2015: 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.

## Indications for use
The Free-Gliding SCFE Screw System is indicated as a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in all pediatric patients (less than or equal to 21 years old) with the exclusion of newborn and infants under 2 years of age.

Source page: https://510kreport.com/device/K131591
Methodology: https://510kreport.com/methodology