510(k) · Cleared
Recalled · 2006Bremer Halo System Titanium Skull Pin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuyacromed · JEC Component, Traction, Invasive
Cleared on Dec 15, 1999 after a 90-day review. The FDA summary names its predicate without a number. 5 later devices descend from it. It has been recalled 15 times.
- Decided
- Dec 15, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- JEC
- Recalls
- 15
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK993099 Bremer Halo System Titanium Skull PinDepuyacromed · 1999
- Descendant · cites it directly · 4 of its ownK171863 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 5 of 5 · See all- K171863Anjon Bremer Halo SystemAnjon Holdings, LLC · 2018 · cites it directly4descendants
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K993099 | Bremer Halo System Titanium Skull Pin | Depuyacromed | 1999 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | — | Bremer Halo System Sterile Cervical Traction Skull Pin Named without a submission number |
What descends from it? (5)
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 |
|---|---|---|---|---|
| Oct 10, 2006 | Not classified | Z-0130-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0139-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0144-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0135-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0137-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0140-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0141-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0131-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0132-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0133-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0134-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0136-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0138-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0142-2007 | Other | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Not classified | Z-0143-2007 | Other | Sterility of device is compromised due to loss of package integrity |
The 5 latest of 15 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K171863 (Anjon Holdings, LLC, 2018) has gone furthest, with 4 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.
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 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993099 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993099: Bremer Halo System Titanium Skull Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993099
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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