FDA Product Code PBJ: Cranial Distraction System
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.
Leading manufacturers include KLS-Martin L.P., Osteomed LP and Synthes USA Products, LLC.
6
Total
6
Cleared
193d
Avg days
2012
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Cranial Distraction System Devices (Product Code PBJ)
6 devices
Cleared
Nov 21, 2023
CranioXpand
KLS-Martin L.P.
Neurology
299d
Cleared
Dec 07, 2017
Craniomaxillofacial Distraction System (CMFD)
Synthes USA Products, LLC
Neurology
262d
Cleared
May 05, 2017
Internal Distraction - Sterile
KLS-Martin L.P.
Neurology
163d
Cleared
Aug 27, 2015
RxG Distraction System
KLS-Martin L.P.
Neurology
156d
Cleared
Jun 03, 2013
OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR
Osteomed LP
Neurology
167d
About Product Code PBJ - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code PBJ since 2012, with 6 receiving FDA clearance (average review time: 193 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.