Cleared Traditional

K220190 - The GIRO Growth Modulation System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220190 · Pega Medical, Inc. · Orthopedic device
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Oct 2022
Decision
273d
Days
Class 2
Risk

K220190 is an FDA 510(k) clearance for the The GIRO Growth Modulation System. Classified as Plate, Bone, Growth Control, Pediatric, Epiphysiodesis (product code OBT), Class II - Special Controls.

Submitted by Pega Medical, Inc. (Laval, CA). The FDA issued a Cleared decision on October 24, 2022 after a review of 273 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Pega Medical, Inc. devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 122d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.