Internal Nail
MechanismMagnetic (ERC)
MaterialTitanium
LoadingModel-, size-, and plan-specific
Lengthening rangeConfirm current IFU for selected model
MRIConfirm current labeling before imaging
StatusCheck current regulator and manufacturer records
● Current status must be verified
Internal Nail
MechanismMagnetic (ERC)
Regulatory historyFDA 510(k) K232267
Recall initiatedSeptember 30, 2024
FDA classificationClass II recall
FDA status checkedOpen on July 12, 2026
Unimplanted devicesFDA record says cease use and return
● Open FDA recall — verify before relying
Internal Nail
MechanismMagnetic (ERC)
MaterialStainless steel
Regulatory historyFDA recall posted March 30, 2021
Reason for concernCorrosion and tissue-reaction reports
Current useDo not treat historical loading claims as current guidance
● Recalled and off market
Internal Nail
MechanismElectromagnetic induction
ControlSubcutaneous receiver + external transmitter
MaterialTitanium
IndicationsVary by jurisdiction and current labeling
StatusVerify current regulator and manufacturer records
● Availability is jurisdiction-specific
External Fixator
MechanismManual (turnbuckle)
StructureCircular rings + tensioned wires
LoadingFrame- and plan-specific
CorrectionCan address multiplanar deformity
Pin-site careFollow the treating team's protocol
● Technique and availability vary
External Fixator
MechanismComputer-guided struts
StructureHexapod (6 telescoping struts)
Correction6 axes simultaneously
PlanningWeb-based software
Potential useMultiplanar correction and lengthening
● Technique and availability vary
Hybrid Method
ConceptExternal fixator + IM nail
Fixator durationIntended to reduce frame time versus frame-only methods
Weight-bearingIM nail provides stability
Risk considerationPins and an intramedullary nail share the treatment course
CostDepends on the complete episode of care
● Surgeon- and center-dependent
Hybrid Method
ConceptLengthen with fixator → insert nail after
StagesTwo surgeries
SequenceNail is inserted after distraction
ConsolidationProtected by nail
CostDepends on the complete episode of care
● Surgeon- and center-dependent
Regulatory status checked against the FDA 510(k) and recall databases on July 12, 2026. Device labeling, availability, and recall status can change.
Loading and treatment instructions must come from the current model-specific labeling and treating team.
Educational reference only. Not medical advice. Device status, treatment parameters, and emergency instructions must be confirmed with current official sources and the treating team.