# K193368: Smart Correction System

- Pathway: 510(k) (Traditional)
- Applicant: Wishbone Medical, Inc.
- Decided: Sep 18, 2020 after 288 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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: 14 generations back to K962616 (1996). 59 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970748: Taylor Spatial Frame External Fixation System, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 4.
- K093047: Smith & Nephew Circular Fixation System, Smith & Nephew, Inc. (2010) Summary page 4.
- K141078: Orthofix TL-Hex True Lok Hexalobe System (TL-Hex), Orthofix Srl (2014) Summary page 4.
- K143125: Orthofix True Lok Hexapod System VI.3, Orthofix Srl (2014) Summary page 4.
- K152171: Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4, Orthofix Srl (2015) Summary page 4.
- K170650: Orthofix TrueLok Hexapod System (TL-HEX) V2.0, Orthofix Srl (2017) Summary page 4.

## Most influential descendants
- K231461: Smart Correction System (HA Half Pins) (2023), 1 descendant of its own
- K221366: Smart Correction System Rings and Compatible HA-Coated Half Pins (2022), 1 descendant of its own
- K252625: The Response Ortho Smart Fixator - Hexapod System (2025), 0 descendants of its own

## Recalls of this device
- Jan 4, 2023 · Class II · Z-1102-2023: Firm identified that user may be unable to adjust the length of the Smart Correction Dual Joint Express Struts due to the collar release pin backing out. This may lead to a delay in correction.

## 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 nonunions Limb Lengthening by epiphyseal or metaphyseal distraction Pseudoarthrosis of long bones

Source page: https://510kreport.com/device/K193368
Methodology: https://510kreport.com/methodology