# K203505: DORO QR3 Headrest System (Aluminum)

- Pathway: 510(k) (Traditional)
- Applicant: Pro Med Instruments GmbH
- Decided: Mar 29, 2021 after 119 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: 2 generations back to K913233 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032331: Doro Radiolucent Headrest System and Horseshoe Headrests,and Non-Radiolucent J-Arm Retractor System (Aluminum Alloy), Pro-Med Instruments GmbH (2003) Summary page 5.

## Indications for use
The DORO QR3 Headrest System is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary.

Source page: https://510kreport.com/device/K203505
Methodology: https://510kreport.com/methodology