# K993099: Bremer Halo System Titanium Skull Pin

- Pathway: 510(k) (Traditional)
- Applicant: Depuyacromed
- Decided: Dec 15, 1999 after 90 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. The FDA summary names its predicate without a number.
- (no number) Bremer Halo System Sterile Cervical Traction Skull Pin: named in the summary without a submission number

## 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

## Indications for use
The Bremer Halo System Titanium Skull Pins are intended for use in conjunction with Bremer's Halo System cervical traction devices and accessories, which provide cervical immobilization necessary for healing and rehabilitation of cervical spinal cord injuries.

Source page: https://510kreport.com/device/K993099
Methodology: https://510kreport.com/methodology