# K221366: Smart Correction System Rings and Compatible HA-Coated Half Pins

- Pathway: 510(k) (Special)
- Applicant: Wishbone Medical, Inc.
- Decided: Jun 6, 2022 after 25 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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: 15 generations back to K962616 (1996). 60 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193368: Smart Correction System, Wishbone Medical, Inc. (2020) Summary page 4.

## Most influential descendants
- K252625: The Response Ortho Smart Fixator - Hexapod System (2025), 0 descendants of its own

## Indications for use
The Smart Correction System is indicated for pediatric subpopulations (excluding newborns) and adults for the following: • Joint contracture resulting in loss of range of motion. • Fractures and disease which generally may result in joint contractures or loss of range of motion. • Fractures requiring distraction. • Open and closed fracture fixation, including fractures of long bones (intracapsular, intertrochanteric, supracondylar, condylar). • Correction of bony or soft tissue defects. • Correction of bony or soft tissue deformities. • Joint arthrodesis. • Infected fractures or nonunion. • Limb Lengthening by epiphyseal or metaphyseal distraction. • Pseudoarthrosis of long bones.

Source page: https://510kreport.com/device/K221366
Methodology: https://510kreport.com/methodology