# K182704: WishBone Guided Growth System

- Pathway: 510(k) (Traditional)
- Applicant: Wishbone Medical
- Decided: Jun 25, 2019 after 271 days
- Product code: OBT (Plate, Bone, Growth Control, Pediatric, Epiphysiodesis)
- 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
Longest line of descent: 4 generations back to K993106 (1999). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090666: Pediplates, OrthoPediatrics Corp. (2009) Summary page 4.
- K171173: OrthoPediatrics Titanium PediPlates® System, OrthoPediatrics Corp. (2017) Summary page 4.
- K110805: Guided Growth System Eight-Plate, Quad-Plate (Stainless Steel), Orthofix, Inc. (2011) Summary page 4.
- K180736: WishBone Medical Plate and Screw System, Wishbone Medical, Inc. (2018). Cleared while this submission was under review Summary page 4.
- K081149: Biopro GO-EZ Screw, Biopro, Inc. (2008) Summary page 4.
- K041595: Toe MP Joint, Models 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870, Biopro, Inc. (2004) Summary page 4.

## Recalls of this device
- Apr 5, 2024 · Class II · Z-1808-2024: The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titanium implant as the packaging and part number indicated.

## Indications for use
The WishBone Medical Guided Growth System is designed for the express and sole purpose of redirecting the angle of growth of long bone(s). This is useful for gradually correcting angular deformities in growing children. Specific conditions/diseases for which the device will be indicated include: valgus, varus or flexion, extension deformities of the knee (femur and/or tibia), valgus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow (humerus), radial or ulnar deviation, flexion or extension deformities of the wrist (radius).

Source page: https://510kreport.com/device/K182704
Methodology: https://510kreport.com/methodology