# K051918: Resolve Open Back Halo Rings

- Pathway: 510(k) (Special)
- Applicant: Jerome Medical
- Decided: Aug 17, 2005 after 33 days
- Product code: HAX (Tong, Skull For Traction)
- Device class: 2
- Regulation: 21 CFR 882.5960
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K822780 (1982). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023959: Jerome Glass Ring, The Jerome Group, Inc. (2003) Summary page 1.

## Recalls of this device
- Jun 21, 2018 · Class II · Z-0999-2019: 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
- Jun 21, 2018 · Class II · Z-1002-2019: 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
- Jun 21, 2018 · Class II · Z-1000-2019: 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
- Jun 21, 2018 · Class II · Z-1001-2019: 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
- 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.

## Indications for use
The ReSOLVE Open Back Halo Ring is intended for use with a Jerome Halo Vest to immobilize and/or provide traction for a cervical spine injury.

Source page: https://510kreport.com/device/K051918
Methodology: https://510kreport.com/methodology