# K170704: The Locking Pediatric Osteotomy Plate (LolliPOP) System

- Pathway: 510(k) (Traditional)
- Applicant: Pega Medical, Inc.
- Decided: Sep 8, 2017 after 184 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K962616 (1996). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914546: Angled Blade Plate, Synthes (Usa) (1991) Summary page 4.
- K033669: Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws), Smith & Nephew, Inc. (2003) Summary page 4.
- K110959: Orthopediatrics Blade Plate System, OrthoPediatrics Corp. (2011) Summary page 4.
- K080109: Synthes (Usa) Modular Blade Plate System, Synthes (Usa) (2008) Summary page 4.

## Indications for use
The Locking Pediatric Osteotomy Plate (LolliPOP) system is a modular hip blade-plate system intended for stable fixation of valgus, varus, derotation, flexion and extension of proximal femoral osteotomies (PFO) and fractures in the pediatric (ages 2 to 21 years old) population. Indications for use include the following: *Inter and subtrochanteric valgus osteotomies *Inter and subtrochanteric varus osteotomies *Inter and subtrochanteric derotation osteotomies *Inter and subtrochanteric flexion and extension osteotomies, *Inter and subtrochanteric fractures.

Source page: https://510kreport.com/device/K170704
Methodology: https://510kreport.com/methodology