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510(k) Data Aggregation
K Number
K202810Device Name
AutoStrut G2
Manufacturer
OrthoSpin Ltd
Date Cleared
2021-01-06
(105 days)
Product Code
KTT, OSN
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
OrthoSpin Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AutoStrut G2 is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which growth plates have fused and will not be crossed with hardware:
- fracture fixation (open and closed)
- pseudoarthrosis of long bones
- limb lengthening (epiphyseal or metaphyseal distraction)
- joint arthrodesis
- infected fractures or nonunions
- correction of bony or soft tissue deformities ●
- correction of segmental defects. ●
Device Description
The AutoStrut G2 is comprised of control system, software, and six length-adjustable struts powered by a motor. The devices are used in conjunction with the DePuy Synthes MAXFRAME multi axial correction system (K161417), including all its parts and software, except that the MAXFRAME struts are substituted with the AutoStrut G2 motorized struts.
The MAXFRAME was cleared with software that generates a treatment plan for the patient, detailing how much each strut should be extended after a given amount of time. The output of this software is downloaded to the AutoStrut G2 control box which will then automatically extend the motorized struts the predetermined amount at the prespecified times. The AutoStrut G2 struts are provided in three (3) sizes, Large, Medium and Small corresponding to the MAXFRAM and should be steam sterilized by the user prior to use.
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