# K230527: WishBone Medical Plate and Screw System

- Pathway: 510(k) (Special)
- Applicant: Wishbone Medical, Inc.
- Decided: Mar 29, 2023 after 30 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: 6 generations back to K981372 (1998). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213489: Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate, Wishbone Medical, Inc. (2022) Summary page 4.
- K180736: WishBone Medical Plate and Screw System, Wishbone Medical, Inc. (2018) Summary page 4.
- K112085: Synthes LCP Pediatric Plate Systems, Synthes (USA) Products, LLC (2011) Summary page 4.

## Indications for use
The WishBone Medical Plate and Screw System is indicated for pediatric and adult patients for 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, and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. The system includes Femoral Locking Plates and Screws, which are indicated for use in infant, child, and adolescent pediatric subgroups and small stature adult patients.

Source page: https://510kreport.com/device/K230527
Methodology: https://510kreport.com/methodology