# K023959: Jerome Glass Ring

- Pathway: 510(k) (Traditional)
- Applicant: The Jerome Group, Inc.
- Decided: Feb 21, 2003 after 86 days
- Product code: HAX (Tong, Skull For Traction)
- Device class: 2
- Regulation: 21 CFR 882.5960
- Recalls of this device: 6 (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). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 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.

## Most influential descendants
- K051918: Resolve Open Back Halo Rings (2005), 0 descendants of its own

## Recalls of this device
- Nov 9, 2008 · Not classified · Z-1509-2009: Ossur initiated the recall after their investigation of some complaints found that in some instances the ceramic pins are difficult to screw through the halo ring.
- Nov 9, 2008 · Not classified · Z-1507-2009: Ossur initiated the recall after their investigation of some complaints found that in some instances the ceramic pins are difficult to screw through the halo ring.
- Nov 9, 2008 · Not classified · Z-1508-2009: Ossur initiated the recall after their investigation of some complaints found that in some instances the ceramic pins are difficult to screw through the halo ring.
- 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 Jerome Glass Ring is intended for use with a Jerome Halo Vest to immobilize andor provide traction for a cervical spine injury.

Source page: https://510kreport.com/device/K023959
Methodology: https://510kreport.com/methodology