510(k) · Cleared
Recalled · Class II · 2020Anjon Bremer Halo System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anjon Holdings, LLC · JEC Component, Traction, Invasive
Cleared on Mar 2, 2020 as substantially equivalent to K171863 (Anjon Holdings, LLC, 2018) and 2 other predicates after a 97-day review. Its family tree reaches back 2 generations to 1992. 3 later devices descend from it. It has been recalled once.
- Decided
- Mar 2, 2020
- Review
- 97 days
- Class
- Class II
- Product code
- JEC
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K915800 (1992). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK915800 Bremer Halo System Cervical Traction Skull PinBremer Medical, Inc. · 1992 · Recalled
- 1 generation backK171863 Anjon Bremer Halo SystemAnjon Holdings, LLC · 2018
- This deviceK193256 Anjon Bremer Halo SystemAnjon Holdings, LLC · 2020
- Descendant · cites it directly · 2 of its ownK243074 Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK252240 Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine · 2026
- Descendant · cites it directly · 0 of its ownK253377 Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See all- K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc. · 2025 · cites it directly2descendants
- K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine · 2026 · 2 generations on0descendants
- K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915800 | Bremer Halo System Cervical Traction Skull Pin | Bremer Medical, Inc. | 1992 | 15 |
| −1 | K171863 | Anjon Bremer Halo System | Anjon Holdings, LLC | 2018 | — |
| 0 (this device) | K193256 | Anjon Bremer Halo System | Anjon Holdings, LLC | 2020 | — |
| +1 | K243074 | Spectrum Spine Lumbar Cage System | Spectrum Spine, Inc. | 2025 | — |
| +2 | K252240 | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | Spectrum Spine | 2026 | — |
| +1 | K253377 | Expandable Titanium PLIF/TLIF System | Spectrum Spine, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
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 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 K203605 SteriTrakscore 1.2 · 1 generation · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K171863 | Anjon Bremer Halo SystemSummary page 5…+1.904.730.9373 Table 2 Predicate devices 510(k) Number Device Manufacturer K171863 Anjon Bremer Halo System Anjon LLC K915800 Bremer Halo System Cervical Traction Sk… | 2018 |
| * | K915800 | Bremer Halo System Cervical Traction Skull PinSummary page 5…k) Number Device Manufacturer K171863 Anjon Bremer Halo System Anjon LLC K915800 Bremer Halo System Cervical Traction Skull Bremer Medical, Inc K993099 Bremer Halo System Titanium Skul… | 1992 |
| * | K993099 | Bremer Halo System Titanium Skull PinSummary page 5…63 Anjon Bremer Halo System Anjon LLC K915800 Bremer Halo System Cervical Traction Skull Bremer Medical, Inc K993099 Bremer Halo System Titanium Skull Pin De Puy Acromed Description of the Device The Anjon Bremer Halo Syste… | 1999 |
What descends from it? (3)
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 18, 2020 | Class II | Z-2778-2020 | Device Design | High rate of galling of one threaded component. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 2 companies; a new generation was cleared every 26.0 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K243074 (Spectrum Spine, Inc., 2025) has gone furthest, with 2 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. 2020, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Anjon Bremer Halo System is indicated for use to provide cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck condition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193256: Anjon Bremer Halo System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193256
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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