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510(k) Data Aggregation
K Number
K213272Device Name
Formus Hip
Manufacturer
Formus Labs, Ltd
Date Cleared
2023-03-31
(547 days)
Product Code
QIH
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Formus Labs, Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Formus Hip is a preoperative surgical planning software. It is intended to assist qualified medical professionals in the preoperative planning of orthopedic surgical procedures.
Device Description
Formus Hip is a semi-automated Software as a Medical Device (SaMD) that allows pre-operative planning of primary total hip arthroplasty in real time using the Zimmer Biomet Taperloc G7 system. Using a series of algorithms, the software creates a 3D model and relevant measurements derived from the patient's pre-dimensioned CT scan. Formus Hip generates a 3D model without any user input. Additional algorithms fit the femoral stem and acetabular cup based on the patient anatomy. The software allows the user to adjust the plan interactively to achieve the desired clinical targets.
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