Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
The Pediatric Epiphysiodesis Bone Growth Control Plate (product code OBT) is an orthopedic implant used to redirect the angle of growth of long bones in pediatric patients with an open physis, indicated for temporary or permanent epiphysiodesis to gradually correct angular deformities such as valgus, varus, or flexion-extension deformities of the knee, ankle, elbow, or wrist. The device may be removed once growth equalization or physeal fusion is achieved. This device is FDA Class 2 under regulation 888.3030 in the Orthopedic specialty, requiring 510(k) clearance, and is notably flagged as both an implant and as life-sustaining/life-supporting.
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Basic Information
- Product Code
- OBT
- Device Class
- FDA class 2
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K220190 | The GIRO Growth Modulation System | Oct 24, 2022 | Substantially Equivalent | Pega Medical, Inc. |
| K182704 | WishBone Guided Growth System | Jun 25, 2019 | Substantially Equivalent | Wishbone Medical |
| K180624 | Guided Growth Plate System Plus | May 15, 2018 | Substantially Equivalent | Orthofix Srl |
| K172183 | Guided Growth Plate System Plus | Jan 09, 2018 | Substantially Equivalent | Orthofix Srl |
| K110805 | GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL) | Jun 21, 2011 | Substantially Equivalent | Orthofix, Inc. |
| K093442 | GUIDED GROWTH SYSTEM | Jun 10, 2010 | Substantially Equivalent | Orthofix, Inc. |
FEI Numbers
This FDA classification entry is associated with 21 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.