# K122225: Sterile Radiolucent Skull Pins

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Apr 26, 2013 after 275 days
- Product code: HBL (Holder, Head, Neurosurgical (Skull Clamp))
- Device class: 2
- Regulation: 21 CFR 882.4460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954789 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954789: Brainlab Headpins, Brainlab AG (1996) Summary page 1.

## Indications for use
Sterile Radiolucent Skull Pins are designed for the fixation of a compatible head-holder unit to the patient's skull. This allows the fixation of the head and neck during craniotomy and subsequent neurosurgical procedures. These pins reduce the incidence of artifacts in images acquired intra-operatively using CT, MR (Conditional) or fluoroscopy.

Source page: https://510kreport.com/device/K122225
Methodology: https://510kreport.com/methodology