510(k) · Cleared
Clearedmb-FIX Cranial Stabilization Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Bees GmbH · HBL Holder, Head, Neurosurgical (Skull Clamp)
Cleared on Nov 6, 2025 as substantially equivalent to K142238 (Integra LifeSciences Corporation, 2014) and 1 other predicate after a 265-day review. Its family tree reaches back 10 generations to 1995. 1 of the 60 devices in its family, counting itself, has a Class I recall.
- Decided
- Nov 6, 2025
- Review
- 265 days
- Class
- Class II
- Product code
- HBL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K944964 (1995). 59 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet. 1 of the 60 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 6 generations between
- 3 generations backK051501 ZiraceAcucera, Inc. · 2005
- 2 generations backK063494 Doro Radiolucent Headrest System ( Also Mri-Compatible) and ComponentsPro-Med Instruments GmbH · 2007
- 1 generation backK072208 Mayfield Disposable and Reusable Titanium Skull PinsIntegra LifeSciences Corporation · 2007
- This deviceK250423 mb-FIX Cranial Stabilization SystemsMedical Bees GmbH · 2025
Show all 10 generations
- Root · 10 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 9 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 8 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 7 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 6 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 5 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- 4 generations backK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
- 3 generations backK051501 ZiraceAcucera, Inc. · 2005
- 2 generations backK063494 Doro Radiolucent Headrest System ( Also Mri-Compatible) and ComponentsPro-Med Instruments GmbH · 2007
- 1 generation backK072208 Mayfield Disposable and Reusable Titanium Skull PinsIntegra LifeSciences Corporation · 2007
- This deviceK250423 mb-FIX Cranial Stabilization SystemsMedical Bees GmbH · 2025
Class I recalls in this family
- K032331 Doro Radiolucent Headrest System and Horseshoe…3 generations back · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −9 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −8 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −7 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −6 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −5 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| −4 | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004… | Nobel Biocare Uas, Inc. | 2004 | — |
| −3 | K051501 | Zirace | Acucera, Inc. | 2005 | — |
| −2 | K063494 | Doro Radiolucent Headrest System ( Also Mri-Compatible) and Components | Pro-Med Instruments GmbH | 2007 | — |
| −1 | K072208 | Mayfield Disposable and Reusable Titanium Skull Pins | Integra LifeSciences Corporation | 2007 | — |
| 0 (this device) | K250423 | mb-FIX Cranial Stabilization Systems | Medical Bees GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 10 | 0 |
| 1994 | 8 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 1 |
| 2005 | 3 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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.
1 device in this family has a Class I recall. 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 K240319 DORO LUCENT Skull Clamp (1101.001); DORO…score 9.9 · 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? (2)
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 |
|---|---|---|---|
| * | K142238 | MAYFIELD Skull ClampSummary page 5…HBL Skull Clamp, Reg. No. 882.4460 HBM Neurosurgical Headrest, Reg. No. 882.4440 Predicate Devices: K142238 Mayfield Skull Clamp K072208 MAYFIELD Disposable and Reusa… | 2014 |
| * | K072208 | Mayfield Disposable and Reusable Titanium Skull PinsSummary page 5…HBM Neurosurgical Headrest, Reg. No. 882.4440 Predicate Devices: K142238 Mayfield Skull Clamp K072208 MAYFIELD Disposable and Reusable Titanium Skull Pins Reference Devices: K191740… | 2007 |
| † | K191740 | DORO LUCENT® iXI and iMRI Headrest System | 2020 |
| † | K941558 | Mayfield Child Disposable Skull Pin | 1995 |
| † | K193438 | DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull… | 2020 |
| † | K163322 | TZ SKULL PIN Adult | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K032331Doro Radiolucent Headrest System and Horseshoe Headrests,and Non-Radiolucent J-Arm Retractor System…Pro-Med Instruments GmbH · 2003 · 3 generations back · ◆ in the 2003 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 12 months on median.
- 9 of the 59 ancestors have a recall of any class; 1 has a Class I 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. 2025, 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?
The mb-FIX Cranial Stabilization System Skull Clamps (Gold Standard Head Holding System, Premium Head Holding System and CT/MRI-compatible Head Holding System) are placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamps and pins are indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary.
The CT/MRI-compatible model and the Titanium or PEEK + Titanium Skull Pins are used when intra-operative imaging is required.
The mb-FIX Cranial Stabilization System provides an interface for accessories like retractor systems, navigation adaptors or other items.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250423 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250423: mb-FIX Cranial Stabilization Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250423
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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