# K083803: Fixit Headrest Clamp System

- Pathway: 510(k) (Traditional)
- Applicant: Medicon EG
- Decided: Mar 10, 2010 after 443 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 K912011 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051440: Mayfield Infinity Skull Clamp, Integra Lifesciences Corp. (2005) Summary page 2.
- K001808: Doro Headrest System, Pro-Med Instruments GmbH (2000) Summary page 2.
- K002276: Psi Skull Clamp, V. Mueller Neuro/Spine (2000). Our reading of the summary gave K002275, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “PSI Skull Clamp”.
- K955012: Mizuho Radiolucent Head Frame, Mizuho America, Inc. (1996) Summary page 2.
- K912011: Codman Skull Clamp, Codman & Shurtleff, Inc. (1991)
- K932807: Mayfield* a-2000 Skull Clamp, Ohio Medical Instrument Co., Inc. (1993) Summary page 2.

## Indications for use
The Medicon FIXIT head rest system is designed to provide stabilization and rigid fixation of patient's skull during surgical operations. It is indicated for neurosurgical operative procedures.

Source page: https://510kreport.com/device/K083803
Methodology: https://510kreport.com/methodology