Search Results
Found 1 results
510(k) Data Aggregation
K Number
K220190Device Name
The GIRO Growth Modulation System
Manufacturer
Pega Medical, Inc.
Date Cleared
2022-10-24
(273 days)
Product Code
OBT, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Pega Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GIRO™ Growth Modulation System is intended as a temporary implant to aid in the correction of the angle of growth of long bones by modulating growth of the physis in pediatric (child and adolescent) patients. It is indicated for the following conditions:
- [ Femur and tibia: varus, valgus, flexion, or extension deformities of the knee.
- □ Humerus: valgus or varus deformities of the elbow.
- □ Radius and ulna: flexion or extension deformities of the wrist.
- □ Ankle: varus, valgus or plantar flexion deformities of the ankle.
- □ Limb length discrepancy of the femur and tibia.
Device Description
The GIRO™ Growth Modulation System is a tether device used for quided growth and deformity correction. It includes two couplings linked via a flexible cable and anchored to the bone via screws and bi-cortical posts. By tethering the growth plate, angular deformities can be corrected. The implants are manufactured in medical grade 316L stainless steel (ASTM F138) and offered in two sizes: 4.5 and 6.0.
Ask a Question
Page 1 of 1