# K190365: Baby Gorilla/Gorilla Plating System

- Pathway: 510(k) (Special)
- Applicant: Paragon 28, Inc.
- Decided: Apr 12, 2019 after 56 days
- Product code: HRS (Plate, Fixation, Bone)
- 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
No predicates in its family tree.
36 later devices descend from it; 6 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K203511: Baby Gorilla/Gorilla Plating System (2020), 17 descendants of its own
- K203817: Tyber Medical Anatomical Plating System (2021), 10 descendants of its own
- K222465: Tyber Medical Anatomical Plating System (2023), 9 descendants of its own
- K221465: Baby Gorilla/Gorilla Plating System (2022), 6 descendants of its own
- K222194: Baby Gorilla®/Gorilla® Plating System (2022), 5 descendants of its own

Source page: https://510kreport.com/device/K190365
Methodology: https://510kreport.com/methodology