OBT — Plate, Bone, Growth Control, Pediatric, Epiphysiodesis Class II
FDA product code OBT covers "Plate, Bone, Growth Control, Pediatric, Epiphysiodesis", a Class II medical device regulated under 21 CFR 888.3030. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OBT
- Device Class
- Class II
- Regulation Number
- 888.3030
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K220190 | pega medical | The GIRO Growth Modulation System | October 24, 2022 |
| K182704 | wishbone medical | WishBone Guided Growth System | June 25, 2019 |
| K180624 | orthofix | Guided Growth Plate System Plus | May 15, 2018 |
| K172183 | orthofix | Guided Growth Plate System Plus | January 9, 2018 |
| K110805 | orthofix | GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL) | June 21, 2011 |
| K093442 | orthofix | GUIDED GROWTH SYSTEM | June 10, 2010 |