Cleared Special

K093442 - GUIDED GROWTH SYSTEM (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K093442 · Orthofix, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
217d
Days
Class 2
Risk

K093442 is an FDA 510(k) clearance for the GUIDED GROWTH SYSTEM. Classified as Plate, Bone, Growth Control, Pediatric, Epiphysiodesis (product code OBT), Class II - Special Controls.

Submitted by Orthofix, Inc. (Mckinney, US). The FDA issued a Cleared decision on June 10, 2010 after a review of 217 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Orthofix, Inc. devices

Submission Details

510(k) Number K093442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2009
Decision Date June 10, 2010
Days to Decision 217 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 122d · This submission: 217d
Pathway characteristics
Modification to existing cleared device.

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.