K220190 is an FDA 510(k) clearance for the The GIRO Growth Modulation System. This device is classified as a Plate, Bone, Growth Control, Pediatric, Epiphysiodesis (Class II - Special Controls, product code OBT).
Submitted by Pega Medical, Inc. (Laval, CA). The FDA issued a Cleared decision on October 24, 2022, 273 days after receiving the submission on January 24, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030. Intended To Redirect The Angle Of Growth Of Long Bone(s) Only In Pediatric Patients. Indicated For Temporary Or Permanent Epiphysiodesis. For Gradually Correcting Angular Deformities Of Long Bones In Pediatric Patients With An Open Physis. Specific Conditions/diseases For Which The Device Will Be Indicated Include Valgus, Varus, Or Flexion Extension Deformities Of The Knee (femur And/or Tibia); Valgus, Varus Or Plantar Flexion Deformities Of The Ankle, Valgus Or Varus Deformities Of The Elbow, As Well As Radial Or Ulnar Deviation, Flexion Or Extension Deformities Of The Wrist (radius). The Device May Be Removed When Growth Has Equalized Or The Growth Plate Has Fused..
| 510(k) Number | K220190 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 2022 |
| Decision Date | October 24, 2022 |
| Days to Decision | 273 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OBT - Plate, Bone, Growth Control, Pediatric, Epiphysiodesis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |
| Definition | Intended To Redirect The Angle Of Growth Of Long Bone(s) Only In Pediatric Patients. Indicated For Temporary Or Permanent Epiphysiodesis. For Gradually Correcting Angular Deformities Of Long Bones In Pediatric Patients With An Open Physis. Specific Conditions/diseases For Which The Device Will Be Indicated Include Valgus, Varus, Or Flexion Extension Deformities Of The Knee (femur And/or Tibia); Valgus, Varus Or Plantar Flexion Deformities Of The Ankle, Valgus Or Varus Deformities Of The Elbow, As Well As Radial Or Ulnar Deviation, Flexion Or Extension Deformities Of The Wrist (radius). The Device May Be Removed When Growth Has Equalized Or The Growth Plate Has Fused. |