# K193256: Anjon Bremer Halo System

- Pathway: 510(k) (Traditional)
- Applicant: Anjon Holdings, LLC
- Decided: Mar 2, 2020 after 97 days
- Product code: JEC (Component, Traction, Invasive)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K915800 (1992). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171863: Anjon Bremer Halo System, Anjon Holdings, LLC (2018) Summary page 5.
- K915800: Bremer Halo System Cervical Traction Skull Pin, Bremer Medical, Inc. (1992) Summary page 5.
- K993099: Bremer Halo System Titanium Skull Pin, Depuyacromed (1999) Summary page 5.

## Most influential descendants
- K243074: Spectrum Spine Lumbar Cage System (2025), 2 descendants of its own
- K252240: Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (2026), 0 descendants of its own
- K253377: Expandable Titanium PLIF/TLIF System (2025), 0 descendants of its own

## Recalls of this device
- Jun 18, 2020 · Class II · Z-2778-2020: High rate of galling of one threaded component.

## Indications for use
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.

Source page: https://510kreport.com/device/K193256
Methodology: https://510kreport.com/methodology