# Wishbone Medical, Inc.

- Location (FDA's records): Warsaw, IN
- FDA decisions: 9 (2017–2023): 9 510(k) clearances
- Names in FDA's records: Wishbone Medical, Inc. (8); Wishbone Medical (1)
- Product codes: HRS (3), KTT (3), HTY (1), OBT (1), HWC (1)
- 510(k) review time since 2016: median 54 days, against 118 for FDA's reviews in the same codes and years (5 of 8 faster)
- Predicates its devices cite: 19 (7 its own); citations of its devices by later devices: 10 (7 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Orthofix, Inc.: 5 (https://510kreport.com/company/orthofix)
- OrthoPediatrics Corp.: 2 (https://510kreport.com/company/orthopediatrics)
- Biopro, Inc.: 2 (https://510kreport.com/company/biopro)
- Synthes (USA) Products, LLC: 1 (https://510kreport.com/company/synthes-usa-products)
- Smith & Nephew, Inc., Orthopaedic Div.: 1 (https://510kreport.com/company/smith-nephew-orthopaedic-div)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)

## Firms that cite its devices most
- Response Ortho Solutions, LLC: 3 (https://510kreport.com/company/response-ortho-solutions)

## Its most-cited devices
- K180736: WishBone Medical Plate and Screw System (2018), cited by 4
- K193368: Smart Correction System (2020), cited by 3
- K221366: Smart Correction System Rings and Compatible HA-Coated Half Pins (2022), cited by 1
- K213489: Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate (2022), cited by 1
- K231461: Smart Correction System (HA Half Pins) (2023), cited by 1

## Recent decisions
- K231461: Smart Correction System (HA Half Pins) (Jun 16, 2023)
- K230527: WishBone Medical Plate and Screw System (Mar 29, 2023)
- K221366: Smart Correction System Rings and Compatible HA-Coated Half Pins (Jun 6, 2022)
- K213489: Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate (Jan 27, 2022)
- K203467: WishBone Medical Plate and Screw System (Dec 23, 2020)
- K193368: Smart Correction System (Sep 18, 2020)
- K182704: WishBone Guided Growth System (Jun 25, 2019)
- K180736: WishBone Medical Plate and Screw System (Oct 4, 2018)

Source page: https://510kreport.com/company/wishbone-medical