510(k) · Cleared
ClearedAnjon 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 19, 2018 as substantially equivalent to K915800 (Bremer Medical, Inc., 1992) and 1 other predicate after a 270-day review. Its family tree reaches back 1 generation to 1992. 4 later devices descend from it.
- Decided
- Mar 19, 2018
- Review
- 270 days
- Class
- Class II
- Product code
- JEC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K915800 (1992). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK915800 Bremer Halo System Cervical Traction Skull PinBremer Medical, Inc. · 1992 · Recalled
- This deviceK171863 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 4 of 4 · See all- 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 |
|---|---|---|---|---|---|
| −1 | K915800 | Bremer Halo System Cervical Traction Skull Pin | Bremer Medical, Inc. | 1992 | 15 |
| 0 (this device) | 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 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 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 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? (2)
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 |
|---|---|---|---|
| * | K915800 | Bremer Halo System Cervical Traction Skull PinSummary page 4…shown below with corresponding 510(k) numbers. Predicate 510(k) Number Device Manufacturer Primary K915800 Bremer Halo System Cervical Traction Skull Pin Bremer Medical, Inc Reference K993099 Bremer Halo System Tit… | 1992 |
| * | K993099 | Bremer Halo System Titanium Skull PinSummary page 4…Device Manufacturer Primary K915800 Bremer Halo System Cervical Traction Skull Pin Bremer Medical, Inc Reference K993099 Bremer Halo System Titanium Skull Pin De Puy Acromed Table 1-1: Predicate… | 1999 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193256 | Anjon Bremer Halo System | 2020 | 3 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JEC devicesJEC Component, Traction, Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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/K171863 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171863: 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/K171863
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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