WishBone Guided Growth System
FDA 510(k) K182704 · Wishbone Medical
510(k) numberK182704
Submission
- Device name
- WishBone Guided Growth System
- Applicant
- Wishbone Medical
Warsaw, IN, US - Received
- September 27, 2018
- Decision date
- June 25, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| 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 |
| K093442 | Guided Growth SystemOBT · Special | Orthofix, Inc. | 06/10/2010SE |
More from Orthofix, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K231461 | Smart Correction System (HA Half Pins)KTT · Special | 06/16/2023SE |
| K230527 | WishBone Medical Plate and Screw SystemHRS · Special | 03/29/2023SE |
| K221366 | Smart Correction System Rings and Compatible HA-Coated Half PinsKTT · Special | 06/06/2022SE |
| K213489 | Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula PlateHRS · Traditional | 01/27/2022SE |
| K203467 | WishBone Medical Plate and Screw SystemHWC · Special | 12/23/2020SE |
| K193368 | Smart Correction SystemKTT · Traditional | 09/18/2020SE |
| K180736 | WishBone Medical Plate and Screw SystemHRS · Traditional | 10/04/2018SE |
| K173013 | WishBone K-Wire SystemHTY · Traditional | 12/14/2017SE |
Questions and answers
When was WishBone Guided Growth System cleared by the FDA?
WishBone Guided Growth System (K182704) received a 510(k) decision of Substantially Equivalent on June 25, 2019, 271 days after the submission was received.
What is the product code of K182704?
The FDA product code is OBT – Plate, Bone, Growth Control, Pediatric, Epiphysiodesis, a Class II (moderate risk) device regulated under 21 CFR 888.3030.