# K180736: WishBone Medical Plate and Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Wishbone Medical, Inc.
- Decided: Oct 4, 2018 after 196 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 4 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K213489: Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate (2022), 1 descendant of its own
- K230527: WishBone Medical Plate and Screw System (2023), 0 descendants of its own
- K203467: WishBone Medical Plate and Screw System (2020), 0 descendants of its own
- K182704: WishBone Guided Growth System (2019), 0 descendants of its own

## Recalls of this device
- Apr 30, 2021 · Class II · Z-1794-2021: Nonconformities were discovered to the engineering specifications for implant plates and screws.

## Indications for use
The WishBone Medical Plate and Screw System is used for pediatric and adult patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include fractures of the clavicle, scapula, humerus, ulna, radius, middle hand, metacarpals, pelvis acetabulum, femur, fibula, tibia, metatarsals and middle foot bones, and treatment of the calcaneus.

Source page: https://510kreport.com/device/K180736
Methodology: https://510kreport.com/methodology