Guided Growth System
FDA 510(k) K093442 · Orthofix, Inc.
510(k) numberK093442
Submission
- Device name
- Guided Growth System
- Applicant
- Orthofix, Inc.
Mckinney, TX, US - Received
- November 5, 2009
- Decision date
- June 10, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBT – Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
- Life-sustaining
- Yes
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)…
Other 510(k)s with product code OBT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220190 | The GIRO Growth Modulation SystemOBT · Traditional | Pega Medical, Inc. | 10/24/2022SE |
| K182704 | WishBone Guided Growth SystemOBT · Traditional | Wishbone Medical | 06/25/2019SE |
| K180624 | Guided Growth Plate System PlusOBT · Special | Orthofix Srl | 05/15/2018SE |
| K172183 | Guided Growth Plate System PlusOBT · Traditional | Orthofix Srl | 01/09/2018SE |
| K110805 | Guided Growth System Eight-Plate, Quad-Plate (Stainless Steel)OBT · Special | Orthofix, Inc. | 06/21/2011SE |
More from Orthofix, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260146 | Fitbone® Transport and Lengthening SystemHSB · Traditional | 05/19/2026SE |
| K253991 | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAHSB · Traditional | 05/08/2026SE |
| K250112 | FitboneTM TrochantericHSB · Traditional | 04/10/2025SE |
| K242270 | OrthoNext Platform SystemQIH · Traditional | 12/19/2024SE |
| K242861 | TrueLok ElevateKTT · Traditional | 12/03/2024SE |
| K233867 | Fitbone TrochantericHSB · Traditional | 06/18/2024SE |
| K240749 | PILLAR SA Ti Spacer System (82-XXX)MAX · Traditional | 05/28/2024SE |
| K232648 | RODEO Telescopic NailHSB · Traditional | 05/03/2024SE |
| K232169 | FITBONE® Transport and Lengthening SystemHSB · Traditional | 03/22/2024SE |
| K213572 | JuniOrtho Plating SystemHWC · Traditional | 01/18/2022SE |
Questions and answers
When was Guided Growth System cleared by the FDA?
Guided Growth System (K093442) received a 510(k) decision of Substantially Equivalent on June 10, 2010, 217 days after the submission was received.
What is the product code of K093442?
The FDA product code is OBT – Plate, Bone, Growth Control, Pediatric, Epiphysiodesis, a Class II (moderate risk) device regulated under 21 CFR 888.3030.