510(k) · Cleared
Recalled · Class II · 2018Cervical Brace
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jerome Medical · JEC Component, Traction, Invasive
Cleared on Oct 6, 1982 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled once.
- Decided
- Oct 6, 1982
- Review
- 22 days
- Class
- Class II
- Product code
- JEC
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK822780 Cervical BraceJerome Medical · 1982
- Descendant · cites it directly · 1 of its ownK040363 Ceramic Tipped Skull PinThe Jerome Group, Inc. · 2004 · Recalled
- Descendant · cites it directly · 1 of its ownK023959 Jerome Glass RingThe Jerome Group, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 0 of its ownK090733 PMT Halo SystemPmt Corp. · 2009
- Descendant · 2 generations on · 0 of its ownK051918 Resolve Open Back Halo RingsJerome Medical · 2005 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K040363Ceramic Tipped Skull PinThe Jerome Group, Inc. · 2004 · cites it directly1descendant
- K023959Jerome Glass RingThe Jerome Group, Inc. · 2003 · cites it directly1descendant
- K090733PMT Halo SystemPmt Corp. · 2009 · 2 generations on0descendants
- K051918Resolve Open Back Halo RingsJerome Medical · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K822780 | Cervical Brace | Jerome Medical | 1982 | — |
| +1 | K040363 | Ceramic Tipped Skull Pin | The Jerome Group, Inc. | 2004 | 4 |
| +1 | K023959 | Jerome Glass Ring | The Jerome Group, Inc. | 2003 | 6 |
| +2 | K090733 | PMT Halo System | Pmt Corp. | 2009 | — |
| +2 | K051918 | Resolve Open Back Halo Rings | Jerome Medical | 2005 | 7 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JEC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JEC device
- #1 K193256 Anjon Bremer Halo Systemscore 3.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-0997-2019 | 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040363 (The Jerome Group, Inc., 2004) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JEC devicesJEC Component, Traction, Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JEC
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JEC
Too few JEC 510(k)s in any year since 2007 to give a median.
Recalls per year · JEC
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEC
2in 2025
MAUDE reports naming product code JEC, 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 | 1 |
| 2008 | 1 | — | 1 | 9 |
| 2009 | 1 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 1 | — | 0 | 15 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 1 | 8 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 2 | — | 1 | 2 |
| 2019 | 1 | — | 1 | 3 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 26 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K822780 · printed Nov 5, 2026
Cite this page
510(k) Report. “K822780: Cervical Brace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K822780
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026