# K974088: Codman Intracranial Bolt

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: Jan 9, 1998 after 71 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
34 later devices descend from it; 3 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CODMAN® MicroSensor™ Skull Bolt: named in the summary without a submission number
- (no number) Camino ICP Bolt: named in the summary without a submission number

## Most influential descendants
- K013930: Neurosensor (2002), 22 descendants of its own
- K050702: Neurosystems 1TM Monitor (2005), 17 descendants of its own
- K061640: Integra Mobius Multi-Modality Monitoring System (2006), 15 descendants of its own
- K080217: Component Neuromonitoring System (2008), 14 descendants of its own
- K062584: Pressio Icp Monitoring System (2007), 8 descendants of its own

## Recalls of this device
- Feb 9, 2012 · Not classified · Z-1279-2012: Codman ICP Skull Bolt wrench is out of specification and cannot be used to turn the screw on the drill

## Indications for use
The CODMAN® Intracranial Bolt is indicated for use as a component of an intracranial pressure (ICP) monitoring system designed to achieve direct ICP monitoring. Specifically, the CODMAN® Intracranial Bolt is intended to secure an ICP transducer during direct ICP monitoring in both subdural and intraparenchymal applications.

Source page: https://510kreport.com/device/K974088
Methodology: https://510kreport.com/methodology