510(k) · Cleared
Recalled · Class II · 2025Head Fiation Device (HFD 100)
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 11, 2011 as substantially equivalent to K081401 (Integra Lifesciences Corp., 2008) and 2 other predicates after a 102-day review. Its family tree reaches back 10 generations to 1995. 1 of the 59 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 11, 2011
- Review
- 102 days
- Class
- Class II
- Product code
- HBL
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 10 generations to K944964 (1995). 56 ancestors in all, the oldest K871863 (1987). 2 later devices descend from it, 2 citing it directly. 1 of the 59 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 deviceK103493 Head Fiation Device (HFD 100)Imris, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK141950 HFD100 Rocker Arm AccessoryImris, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK113748 Imris MR/X-Ray Head Fixation Device (HFD)Imris, Inc. · 2012 · Recalled
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 deviceK103493 Head Fiation Device (HFD 100)Imris, Inc. · 2011
Class I recalls in this family
- K032331 Doro Radiolucent Headrest System and Horseshoe…2 generations back · 2003
Most influential descendants
Showing 2 of 2 · See allView 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) | K103493 | Head Fiation Device (HFD 100) | Imris, Inc. | 2011 | — |
| +1 | K141950 | HFD100 Rocker Arm Accessory | Imris, Inc. | 2014 | — |
| +1 | K113748 | Imris MR/X-Ray Head Fixation Device (HFD) | Imris, Inc. | 2012 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K081401 | Mayfield MR/X-Ray Skull ClampSummary page 2…IMRIS Inc. Corporation LifeSciences instruments GmbH Corporation FDA 51 0(k) # K081401 K072208 K063494 Subject Device… | 2008 |
| * | K072208 | Mayfield Disposable and Reusable Titanium Skull PinsSummary page 1…Oct 8, 2008 Integra LifeSciences Clamp corporation MAYFIELD® Disposable and K072208 Sep 7, 2007 Integra LifeSciences Reusable Titanium Skull Pins corporation… | 2007 |
| * | K063494 | Doro Radiolucent Headrest System ( Also Mri-Compatible) and ComponentsSummary page 1…Sep 7, 2007 Integra LifeSciences Reusable Titanium Skull Pins corporation DORO® RadiolucentlMRl K063494 May 21, 2007 Pro med instruments Compatible Cranial stabilization GmbH Conf… | 2007 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 8, 2025 | Class II | Z-1034-2026 | Device Design | Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury. |
| Feb 17, 2022 | Class II | Z-0934-2022 | Device Design | Reports have been received that after normal or routine lateral forces are applied to the head fixation device, the split block clamp may deflect (rotationally around the axis) and not return to within acceptable distance from its prior… |
| Aug 14, 2017 | Class II | Z-3211-2017 | Process control | incorrect thread on thumbscrews |
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 16 years and passes through 7 companies; a new generation was cleared every 12 months on median.
- 8 of the 56 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K141950 (Imris, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K081401.
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. 2011, 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 Head Fixation Device System is an MR compatible mechanical support system which is used in head, neck and spine surgery when rigid fixation is required for cranial stabilization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103493: Head Fiation Device (HFD 100).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103493
Report an extraction error
Are you the manufacturer?
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