# K032331: Doro Radiolucent Headrest System and Horseshoe Headrests,and Non-Radiolucent J-Arm Retractor System (Aluminum Alloy)

- Pathway: 510(k) (Traditional)
- Applicant: Pro-Med Instruments GmbH
- Decided: Nov 20, 2003 after 114 days
- Product code: HBL (Holder, Head, Neurosurgical (Skull Clamp))
- Device class: 2
- Regulation: 21 CFR 882.4460
- Recalls of this device: 3 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913233 (1991). 3 ancestors in all.
10 later devices descend from it; 3 cite it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001808: Doro Headrest System, Pro-Med Instruments GmbH (2000) Summary page 2.
- K953124: Mayfield Radiolucent 2000 Skull Clamp, Ohio Medical Instrument Co., Inc. (1996) Summary page 2.
- K913233: Codman Lhalo Split Ring Retractor System, Codman & Shurtleff, Inc. (1991) Summary page 2.

## Most influential descendants
- 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
- K250423: mb-FIX Cranial Stabilization Systems (2025), 0 descendants of its own

## Recalls of this device
- Jul 5, 2018 · Class I · Z-2971-2018: The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headre
- Jul 5, 2018 · Class I · Z-2970-2018: The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headre
- Jul 5, 2018 · Class I · Z-2972-2018: The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headre

## Indications for use
The DORO Radiolucent Headrest System is used in open and percutaneous craniotomies and spinal surgeries for rigid cranial fixation and when intraoperative CT imaging is used. The DOROO J-ARM Retractor Accessory is used to fix tissue retractor during neurosurgical procedures.

Source page: https://510kreport.com/device/K032331
Methodology: https://510kreport.com/methodology