510(k) · Cleared
Recalled · Class II · 2018Resolve Open Back Halo Rings
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jerome Medical · HAX Tong, Skull For Traction
Cleared on Aug 17, 2005 as substantially equivalent to K023959 (The Jerome Group, Inc., 2003) after a 33-day review. Its family tree reaches back 2 generations to 1982. It has been recalled 7 times.
- Decided
- Aug 17, 2005
- Review
- 33 days
- Class
- Class II
- Product code
- HAX
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 2 generations to K822780 (1982). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HAX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023959 | Jerome Glass RingSummary page 1…ication Name: Tong, Skull for Traction, Sec. 882.5960, Neurological Devices, Class II, HAX Substantially Equ~ivalent To: ReSOLVE Closed Back Halo Ring (K023959) manufactured by Jerome Medical. Also similar to the V1 Halo Ring (K9301 53) manufactured by Jerome Medical.… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 21, 2018 | Class II | Z-0999-2019 | Labeling design | 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 lists ceramic tip. The second line… |
| Jun 21, 2018 | Class II | Z-1002-2019 | Labeling design | 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 lists ceramic tip. The second line… |
| Jun 21, 2018 | Class II | Z-1000-2019 | Labeling design | 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 lists ceramic tip. The second line… |
| Jun 21, 2018 | Class II | Z-1001-2019 | Labeling design | 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 lists ceramic tip. The second line… |
| Nov 9, 2008 | Not classified | Z-1509-2009 | Process change control | 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 | Process change control | 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 | Process change control | 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. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 20.4 years on median.
- 2 of the 2 ancestors have a recall of any class.
How does its category compare?
All HAX devicesHAX Tong, Skull For Traction: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAX
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · HAX
Too few HAX 510(k)s in any year since 2007 to give a median.
Recalls per year · HAX
4in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HAX
1in 2020
MAUDE reports naming product code HAX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 3 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 6 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 4 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051918 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051918: Resolve Open Back Halo Rings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051918
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026