FDA product code OBT: Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
OBT is the FDA product code for plate, bone, growth control, pediatric, epiphysiodesis. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel. FDA has cleared 6 510(k) submissions under OBT, 1 in the last five years, from 4 different applicants. The average 510(k) review took 182 days (median 196). FDA has posted 1 recall for OBT devices, 1 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Plate, Bone, Growth Control, Pediatric, Epiphysiodesis |
| Device class | Class II |
| Regulation | 21 CFR 888.3030 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for OBT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 120 |
| 2019 | 1 | 271 |
| 2022 | 1 | 273 |
Compare with all 510(k) review times · Search every OBT clearance
Top OBT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orthofix Srl | 2 | 2018-05-15 |
| Orthofix, Inc. | 2 | 2011-06-21 |
| Pega Medical, Inc. | 1 | 2022-10-24 |
| Wishbone Medical | 1 | 2019-06-25 |
Most recent OBT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220190 | Pega Medical, Inc. | The GIRO Growth Modulation System | 2022-10-24 | 273 |
| K182704 | Wishbone Medical | WishBone Guided Growth System | 2019-06-25 | 271 |
| K180624 | Orthofix Srl | Guided Growth Plate System Plus | 2018-05-15 | 67 |
| K172183 | Orthofix Srl | Guided Growth Plate System Plus | 2018-01-09 | 174 |
| K110805 | Orthofix, Inc. | GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL) | 2011-06-21 | 90 |
Recalls for OBT devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-04-05.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code OBT?
OBT is the FDA product code for plate, bone, growth control, pediatric, epiphysiodesis. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel.
What device class is OBT?
Class II, regulation 21 CFR 888.3030. Typical premarket route: 510(k).
How long does a 510(k) take for product code OBT?
Across 6 cleared submissions the average was 182 days from receipt to decision (median 196).
Which companies have the most OBT clearances?
Orthofix Srl (2); Orthofix, Inc. (2); Pega Medical, Inc. (1); Wishbone Medical (1).
Have OBT devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-04-05.
Next steps
- Run an FDA pathway report with predicate devices for product code OBT
- Run a recall and safety report across every OBT manufacturer
- Watch product code OBT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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