# K242452: Monkey Bars Pin to Bar External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: Nov 1, 2024 after 74 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: 3 generations back to K831576 (1983). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211112: OIC External Fixation System, Orthopaedic Implant Company (2021) Summary page 6.
- K113770: Orthofix Galaxy Fixation System, Orthofix Srl (2012) Summary page 6.

## Indications for use
The Monkey Bars Pin to Bar External Fixation System is intended to be used in adult and pediatric patients (specifically, children and adolescents aged 2 through 21 years) for provisional fixation of open and/or unstable fractures in the lower and upper extremities and pelvis. It may also be used for temporary fixation of peri-articular or intra-articular fractures. Additionally, the device can be used on fractures where soft tissue injury or an infected fracture site may preclude the use of other fracture fixation treatments.

Source page: https://510kreport.com/device/K242452
Methodology: https://510kreport.com/methodology