510(k) · Cleared
ClearedSterile Radiolucent Skull Pins
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · HBL Holder, Head, Neurosurgical (Skull Clamp)
Cleared on Apr 26, 2013 as substantially equivalent to K954789 (Brainlab AG, 1996) after a 275-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Apr 26, 2013
- Review
- 275 days
- Class
- Class II
- Product code
- HBL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954789 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK954789 Brainlab HeadpinsBrainlab AG · 1996
- This deviceK122225 Sterile Radiolucent Skull PinsBrainlab AG · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954789 | Brainlab Headpins | Brainlab AG | 1996 | — |
| 0 (this device) | K122225 | Sterile Radiolucent Skull Pins | Brainlab AG | 2013 | — |
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 HBL? 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 HBL device
- #1 K250423 mb-FIX Cranial Stabilization Systemsscore 13.0 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K954789 | Brainlab HeadpinsSummary page 1…diolucent Skull Pins Trade name: Sterile Radiolucent Skull Pins Common/Classification Disposable Head Pins Name: Predicate Device: Brainlab Headpins (K954789) Device classification Neurosurgical Head Holder (Skull Clamp) name: Regulatory Class: Class 11 Regulation Number: Produc… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All HBL devicesHBL Holder, Head, Neurosurgical (Skull Clamp): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · HBL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HBL
54in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HBL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBL
272in 2025
MAUDE reports naming product code HBL, 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 | 3 | 30 | 0 | 39 |
| 2008 | 2 | — | 0 | 103 |
| 2009 | 3 | 54 | 0 | 97 |
| 2010 | 1 | — | 0 | 154 |
| 2011 | 1 | — | 0 | 199 |
| 2012 | 2 | — | 1 | 170 |
| 2013 | 2 | — | 1 | 148 |
| 2014 | 2 | — | 0 | 166 |
| 2015 | 0 | — | 0 | 196 |
| 2016 | 0 | — | 0 | 280 |
| 2017 | 1 | — | 1 | 296 |
| 2018 | 0 | — | 0 | 305 |
| 2019 | 2 | — | 1 | 1,028 |
| 2020 | 2 | — | 1 | 607 |
| 2021 | 1 | — | 0 | 512 |
| 2022 | 0 | — | 1 | 268 |
| 2023 | 0 | — | 0 | 265 |
| 2024 | 2 | — | 0 | 197 |
| 2025 | 1 | — | 1 | 272 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Sterile Radiolucent Skull Pins are designed for the fixation of a compatible head-holder unit to the patient's skull. This allows the fixation of the head and neck during craniotomy and subsequent neurosurgical procedures. These pins reduce the incidence of artifacts in images acquired intra-operatively using CT, MR (Conditional) or fluoroscopy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122225 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122225: Sterile Radiolucent Skull Pins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122225
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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