510(k) · Cleared
Recalled · 2006Bremer Halo System Cervical Traction Skull Pin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bremer Medical, Inc. · JEC Component, Traction, Invasive
Cleared on Mar 16, 1992 after an 83-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it. It has been recalled 15 times.
- Decided
- Mar 16, 1992
- Review
- 83 days
- Class
- Class II
- Product code
- JEC
- Recalls
- 15
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK915800 Bremer Halo System Cervical Traction Skull PinBremer Medical, Inc. · 1992
- Descendant · cites it directly · 4 of its ownK171863 Anjon Bremer Halo SystemAnjon Holdings, LLC · 2018
- Descendant · cites it directly · 3 of its ownK193256 Anjon Bremer Halo SystemAnjon Holdings, LLC · 2020 · Recalled
- Descendant · 2 generations on · 2 of its ownK243074 Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK252240 Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine · 2026
- Descendant · 2 generations on · 0 of its ownK253377 Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc. · 2025
Most influential descendants
Showing 5 of 5 · See all- K171863Anjon Bremer Halo SystemAnjon Holdings, LLC · 2018 · cites it directly4descendants
- K193256Anjon Bremer Halo SystemAnjon Holdings, LLC · 2020 · cites it directly3descendants
- K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc. · 2025 · 2 generations on2descendants
- K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine · 2026 · 3 generations on0descendants
- K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915800 | Bremer Halo System Cervical Traction Skull Pin | Bremer Medical, Inc. | 1992 | — |
| +1 | K171863 | Anjon Bremer Halo System | Anjon Holdings, LLC | 2018 | — |
| +1 | K193256 | Anjon Bremer Halo System | Anjon Holdings, LLC | 2020 | 1 |
| +2 | K243074 | Spectrum Spine Lumbar Cage System | Spectrum Spine, Inc. | 2025 | — |
| +3 | K252240 | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | Spectrum Spine | 2026 | — |
| +2 | K253377 | Expandable Titanium PLIF/TLIF System | Spectrum Spine, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
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 |
|---|---|---|---|---|
| Oct 10, 2006 | Not classified | Z-0130-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0139-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0144-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0135-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0137-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0140-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0141-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0131-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0132-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0133-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0134-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0136-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0138-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0142-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0143-2007 | Other | Sterility of device is compromised due to loss of package integrity |
The 5 latest of 15 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K171863 (Anjon Holdings, LLC, 2018) has gone furthest, with 4 descendants 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/K915800 · printed Nov 4, 2026
Cite this page
510(k) Report. “K915800: Bremer Halo System Cervical Traction Skull Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K915800
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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