# K250423: mb-FIX Cranial Stabilization Systems

- Pathway: 510(k) (Traditional)
- Applicant: Medical Bees GmbH
- Decided: Nov 6, 2025 after 265 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: 10 generations back to K944964 (1995). 59 ancestors in all.
No later device cites it as a predicate yet.
1 of 60 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142238: MAYFIELD Skull Clamp, Integra LifeSciences Corporation (2014) Summary page 5.
- K072208: Mayfield Disposable and Reusable Titanium Skull Pins, Integra LifeSciences Corporation (2007) Summary page 5.

## Indications for use
The mb-FIX Cranial Stabilization System Skull Clamps (Gold Standard Head Holding System, Premium Head Holding System and CT/MRI-compatible Head Holding System) are placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamps and pins are indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary. The CT/MRI-compatible model and the Titanium or PEEK + Titanium Skull Pins are used when intra-operative imaging is required. The mb-FIX Cranial Stabilization System provides an interface for accessories like retractor systems, navigation adaptors or other items.

Source page: https://510kreport.com/device/K250423
Methodology: https://510kreport.com/methodology