510(k) · Cleared
Recalled · Class II · 2019Imris MR/X-Ray Head Fixation Device (HFD)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imris, Inc. · HBL Holder, Head, Neurosurgical (Skull Clamp)
Cleared on Mar 23, 2012 as substantially equivalent to K103493 (Imris, Inc., 2011) and 2 other predicates after a 93-day review. Its family tree reaches back 11 generations to 1995. 1 of the 58 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Mar 23, 2012
- Review
- 93 days
- Class
- Class II
- Product code
- HBL
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 11 generations to K944964 (1995). 57 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet. 1 of the 58 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 7 generations between
- 3 generations backK063494 Doro Radiolucent Headrest System ( Also Mri-Compatible) and ComponentsPro-Med Instruments GmbH · 2007
- 2 generations backK072208 Mayfield Disposable and Reusable Titanium Skull PinsIntegra LifeSciences Corporation · 2007
- 1 generation backK103493 Head Fiation Device (HFD 100)Imris, Inc. · 2011 · Recalled
- This deviceK113748 Imris MR/X-Ray Head Fixation Device (HFD)Imris, Inc. · 2012
Show all 11 generations
- Root · 11 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 10 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 9 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 8 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 7 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 6 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- 5 generations backK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
- 4 generations backK051501 ZiraceAcucera, Inc. · 2005
- 3 generations backK063494 Doro Radiolucent Headrest System ( Also Mri-Compatible) and ComponentsPro-Med Instruments GmbH · 2007
- 2 generations backK072208 Mayfield Disposable and Reusable Titanium Skull PinsIntegra LifeSciences Corporation · 2007
- 1 generation backK103493 Head Fiation Device (HFD 100)Imris, Inc. · 2011 · Recalled
- This deviceK113748 Imris MR/X-Ray Head Fixation Device (HFD)Imris, Inc. · 2012
Class I recalls in this family
- K032331 Doro Radiolucent Headrest System and Horseshoe…2 generations back · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −10 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −9 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −8 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −7 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −6 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| −5 | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004… | Nobel Biocare Uas, Inc. | 2004 | — |
| −4 | K051501 | Zirace | Acucera, Inc. | 2005 | — |
| −3 | K063494 | Doro Radiolucent Headrest System ( Also Mri-Compatible) and Components | Pro-Med Instruments GmbH | 2007 | — |
| −2 | K072208 | Mayfield Disposable and Reusable Titanium Skull Pins | Integra LifeSciences Corporation | 2007 | — |
| −1 | K103493 | Head Fiation Device (HFD 100) | Imris, Inc. | 2011 | 3 |
| 0 (this device) | K113748 | Imris MR/X-Ray Head Fixation Device (HFD) | Imris, Inc. | 2012 | — |
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 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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 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? (3)
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 |
|---|---|---|---|
| * | K103493 | Head Fiation Device (HFD 100)Summary page 1…510(K) DATE OF MANUFACTURER NUMBER CLEARANCE IMRIS Head Fixation Device (HFD100) K103493 Nov 29, 2010 IMRIS Inc. MAYFIELD@ MR/X-Ray Skull Clamp K081 401 Oct 8,2008 Integra LifeSciences… | 2011 |
| * | K081401 | Mayfield MR/X-Ray Skull ClampSummary page 1…NUMBER CLEARANCE IMRIS Head Fixation Device (HFD100) K103493 Nov 29, 2010 IMRIS Inc. MAYFIELD@ MR/X-Ray Skull Clamp K081 401 Oct 8,2008 Integra LifeSciences corporation DO… | 2008 |
| * | K063494 | Doro Radiolucent Headrest System ( Also Mri-Compatible) and ComponentsSummary page 1…1 Oct 8,2008 Integra LifeSciences corporation DORO® Radiolucent/MRI Compatible K063494 May 21, 2007 Pro med instruments Cranial stabilization GmbH… | 2007 |
| † | K021604 | Mayfield Radiolucent Skull Pins, Model 4-0-a-2020 | 2002 |
| † | K072208 | Mayfield Disposable and Reusable Titanium Skull Pins | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 26, 2019 | Class II | Z-0163-2020 | Device Design | Breaking of the HFD200 Drive Knob force indicator due to over-torqueing of the drive knob beyond the maximum allowable pinning force specification may result in the clinical staff unknowingly pinning the patient's skull with insufficient… |
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 · 2 generations back · ◆ in the 2003 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 17 years and passes through 7 companies; a new generation was cleared every 12 months on median.
- 9 of the 57 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K103493.
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. 2012, 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 IMRIS MR/X-ray Head Fixation Device System is an MR safe mechanical support system which is used in head, neck and spine surgery when rigid fixation is required for cranial stabilization. The MR/X-ray HFD is indicated for use during utilization of imaging modalities such as intraoperative MRI, CT imaging, and C-Arm X-ray angiography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113748 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113748: Imris MR/X-Ray Head Fixation Device (HFD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113748
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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