FDA product code PBJ: Cranial Distraction System
PBJ is the FDA product code for cranial distraction system. It is a Class II device, regulated under 21 CFR 882.5330 and reviewed by the Neurology panel. FDA has cleared 6 510(k) submissions under PBJ, 1 in the last five years, from 5 different applicants. The average 510(k) review took 193 days (median 165).
Definition
A cranial distraction system is a metal device intended to establish osteodistraction and bone growth in the skull. The bone segments are attached to the plate with screws to prevent movement of the segments.
Classification
| Field | Value |
|---|---|
| Device name | Cranial Distraction System |
| Device class | Class II |
| Regulation | 21 CFR 882.5330 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for PBJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 212 |
| 2023 | 1 | 299 |
Top PBJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| KLS Martin L.P. | 2 | 2017-05-05 |
| KLS-Martin L.P. | 1 | 2023-11-21 |
| Synthes USA Products, LLC | 1 | 2017-12-07 |
| Osteomed LP | 1 | 2013-06-03 |
| Osteomed | 1 | 2012-08-22 |
Most recent PBJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K230211 | KLS-Martin L.P. | CranioXpand | 2023-11-21 | 299 |
| K170818 | Synthes USA Products, LLC | Craniomaxillofacial Distraction System (CMFD) | 2017-12-07 | 262 |
| K163315 | KLS Martin L.P. | Internal Distraction - Sterile | 2017-05-05 | 163 |
| K150771 | KLS Martin L.P. | RxG Distraction System | 2015-08-27 | 156 |
| K123885 | Osteomed LP | OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR | 2013-06-03 | 167 |
Recalls for PBJ devices
openFDA lists no recalls for product code PBJ.
Frequently asked questions
What is FDA product code PBJ?
PBJ is the FDA product code for cranial distraction system. It is a Class II device, regulated under 21 CFR 882.5330 and reviewed by the Neurology panel.
What device class is PBJ?
Class II, regulation 21 CFR 882.5330. Typical premarket route: 510(k).
How long does a 510(k) take for product code PBJ?
Across 6 cleared submissions the average was 193 days from receipt to decision (median 165).
Which companies have the most PBJ clearances?
KLS Martin L.P. (2); KLS-Martin L.P. (1); Synthes USA Products, LLC (1); Osteomed LP (1); Osteomed (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PBJ
- Run a recall and safety report across every PBJ manufacturer
- Watch product code PBJ 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.