# K040363: Ceramic Tipped Skull Pin

- Pathway: 510(k) (Traditional)
- Applicant: The Jerome Group, Inc.
- Decided: Apr 12, 2004 after 59 days
- Product code: LYT (Fixation Accessory)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K822780 (1982). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K822780: Cervical Brace, Jerome Medical (1982) Summary page 1.
- K930153: System Iii Halo Ring, Jerome Medical (1993) Summary page 1.

## Most influential descendants
- K090733: PMT Halo System (2009), 0 descendants of its own

## Recalls of this device
- Jun 21, 2018 · Class II · Z-0998-2019: Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly
- Sep 26, 2008 · Not classified · Z-0594-2009: Ossur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products.
- Sep 26, 2008 · Not classified · Z-0595-2009: Ossur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products.
- Sep 26, 2008 · Not classified · Z-0596-2009: Ossur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products.

## Indications for use
The Ceramic Tipped Skull Pins are similar to other skull pins which, when used as part of a Halo Traction System. are designed to hold the skull firmly inplace relative to the btrso so cervical vertebrae are immobilized following surgery or injury.

Source page: https://510kreport.com/device/K040363
Methodology: https://510kreport.com/methodology