Cleared Special

K180624 - Guided Growth Plate System Plus

K180624 is an FDA 510(k) clearance for Guided Growth Plate System Plus, manufactured by Orthofix Srl. The device is a Class 2 Orthopedic device with product code OBT cleared through the Special 510(k) pathway after a 67-day FDA review.

K180624 · Orthofix Srl · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
67d
Days
Class 2
Risk

K180624 is an FDA 510(k) clearance for the Guided Growth Plate System Plus. Classified as Plate, Bone, Growth Control, Pediatric, Epiphysiodesis (product code OBT), Class II - Special Controls.

Submitted by Orthofix Srl (Bussolengo, IT). The FDA issued a Cleared decision on May 15, 2018 after a review of 67 days - a notably fast clearance 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K180624

510(k) Number K180624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2018
Decision Date May 15, 2018
Days to Decision 67 days
Submission Type Special
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
55d faster than avg
Panel avg: 122d · This submission: 67d
Pathway characteristics
Modification to existing cleared device.

OBT Device Classification - Class 2, Special Controls

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.

Regulatory Consultant

Wagoner Consulting, LLC
Gianluca Ricadona

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

Devices cleared under the same product code (OBT) and FDA review panel - the closest regulatory comparables to K180624.
The GIRO Growth Modulation System
K220190 · Pega Medical, Inc. · Oct 2022
WishBone Guided Growth System
K182704 · Wishbone Medical · Jun 2019
Guided Growth Plate System Plus
K172183 · Orthofix Srl · Jan 2018
GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)
K110805 · Orthofix, Inc. · Jun 2011
GUIDED GROWTH SYSTEM
K093442 · Orthofix, Inc. · Jun 2010
K180624 · Guided Growth Plate System Plus
Download PDF FDA Summary Orthofix Srl