# K001808: Doro Headrest System

- Pathway: 510(k) (Traditional)
- Applicant: Pro-Med Instruments GmbH
- Decided: Aug 4, 2000 after 50 days
- Product code: HBL (Holder, Head, Neurosurgical (Skull Clamp))
- Device class: 2
- Regulation: 21 CFR 882.4460
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 3 cite it directly.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032331: Doro Radiolucent Headrest System and Horseshoe Headrests,and Non-Radiolucent J-Arm Retractor System (Aluminum Alloy) (2003), 10 descendants of its own
- K063494: Doro Radiolucent Headrest System ( Also Mri-Compatible) and Components (2007), 7 descendants of its own
- K072208: Mayfield Disposable and Reusable Titanium Skull Pins (2007), 4 descendants of its own
- K103493: Head Fiation Device (HFD 100) (2011), 2 descendants of its own
- K191740: DORO LUCENT® iXI and iMRI Headrest System (2020), 1 descendant of its own

## Recalls of this device
- Mar 14, 2025 · Class II · Z-1860-2025: Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.
- Nov 2, 2017 · Class II · Z-0193-2018: The firm received reports of two breakages of the pin tips which occurred during two identical surgery procedures. The breakage occurred at the very distal end of the conical part of the skull pin tip

Source page: https://510kreport.com/device/K001808
Methodology: https://510kreport.com/methodology