# K915800: Bremer Halo System Cervical Traction Skull Pin

- Pathway: 510(k) (Traditional)
- Applicant: Bremer Medical, Inc.
- Decided: Mar 16, 1992 after 83 days
- Product code: JEC (Component, Traction, Invasive)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K171863: Anjon Bremer Halo System (2018), 4 descendants of its own
- K193256: Anjon Bremer Halo System (2020), 3 descendants of its own
- 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
- Oct 10, 2006 · Not classified · Z-0130-2007: Sterility of device is compromised due to loss of package integrity
- Oct 10, 2006 · Not classified · Z-0139-2007: Sterility of device is compromised due to loss of package integrity
- Oct 10, 2006 · Not classified · Z-0144-2007: Sterility of device is compromised due to loss of package integrity
- Oct 10, 2006 · Not classified · Z-0135-2007: Sterility of device is compromised due to loss of package integrity
- Oct 10, 2006 · Not classified · Z-0137-2007: Sterility of device is compromised due to loss of package integrity
- Oct 10, 2006 · Not classified · Z-0140-2007: Sterility of device is compromised due to loss of package integrity
- Oct 10, 2006 · Not classified · Z-0141-2007: Sterility of device is compromised due to loss of package integrity
- Oct 10, 2006 · Not classified · Z-0131-2007: Sterility of device is compromised due to loss of package integrity
- Oct 10, 2006 · Not classified · Z-0132-2007: Sterility of device is compromised due to loss of package integrity
- Oct 10, 2006 · Not classified · Z-0133-2007: Sterility of device is compromised due to loss of package integrity
- Oct 10, 2006 · Not classified · Z-0134-2007: Sterility of device is compromised due to loss of package integrity
- Oct 10, 2006 · Not classified · Z-0136-2007: Sterility of device is compromised due to loss of package integrity
- Oct 10, 2006 · Not classified · Z-0138-2007: Sterility of device is compromised due to loss of package integrity
- Oct 10, 2006 · Not classified · Z-0142-2007: Sterility of device is compromised due to loss of package integrity
- Oct 10, 2006 · Not classified · Z-0143-2007: Sterility of device is compromised due to loss of package integrity

Source page: https://510kreport.com/device/K915800
Methodology: https://510kreport.com/methodology