# K213489: Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate

- Pathway: 510(k) (Traditional)
- Applicant: Wishbone Medical, Inc.
- Decided: Jan 27, 2022 after 87 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
Longest line of descent: 1 generation back to K180736 (2018). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180736: WishBone Medical Plate and Screw System, Wishbone Medical, Inc. (2018) Summary page 4.

## Most influential descendants
- K230527: WishBone Medical Plate and Screw System (2023), 0 descendants of its own

## 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. Specifically, the Straight Fibula Plates are intended for use in infant, child, and adolescent pediatric subgroups and adult patients.

Source page: https://510kreport.com/device/K213489
Methodology: https://510kreport.com/methodology