510(k) · Cleared
ClearedLimited Artifact Skull Pin, Model 0107
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dinkler Surgical Devices, Inc. · HBL Holder, Head, Neurosurgical (Skull Clamp)
Cleared on Feb 28, 2008 as substantially equivalent to K923789 (Ohio Medical Instrument Co., Inc., 1993) after a 111-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- Feb 28, 2008
- Review
- 111 days
- Class
- Class II
- Product code
- HBL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923789 (1993). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK923789 Mayfield Adult Disposable Skull PinOhio Medical Instrument Co., Inc. · 1993
- This deviceK073163 Limited Artifact Skull Pin, Model 0107Dinkler Surgical Devices, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK193438 DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile…Pro Med Instruments GmbH · 2020
- Descendant · 2 generations on · 0 of its ownK241883 DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs)…Pro Med Instruments GmbH · 2024
Most influential descendants
Showing 2 of 2 · See all- K193438DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull…Pro Med Instruments GmbH · 2020 · cites it directly1descendant
- K241883DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO…Pro Med Instruments GmbH · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923789 | Mayfield Adult Disposable Skull Pin | Ohio Medical Instrument Co., Inc. | 1993 | — |
| 0 (this device) | K073163 | Limited Artifact Skull Pin, Model 0107 | Dinkler Surgical Devices, Inc. | 2008 | — |
| +1 | K193438 | DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable… | Pro Med Instruments GmbH | 2020 | — |
| +2 | K241883 | DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00)… | Pro Med Instruments GmbH | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 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 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 |
|---|---|---|---|
| * | K923789 | Mayfield Adult Disposable Skull PinSummary page 1…gical Devices believes based on the information provided that the Limited Artifact Skull Pin is substantially equivalent to the Mayfield Disposable Skull Pin 4-o-A-1o72 (K923789). Device Description: The Limited Artifact Skull Pins consists of an injection molded PEEK polymer base, a machined titanium pin… | 1993 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193438 | DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull… | 2020 | 1 |
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?
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. 2008, 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 Limited Artifact Skull Pins are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is required and during intra-operative use within a MR environment rated up to and including a 1.5 Tesla magnetic field. The Limited Artifact Skull Pins are used in open and percutaneous craniotomies such as biopsies, thalamotomies and electrode implants; and in spinal surgeries when rigid skeletal fixation is…
Read the full statement (130 words)
The Limited Artifact Skull Pins are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is required and during intra-operative use within a MR environment rated up to and including a 1.5 Tesla magnetic field.
The Limited Artifact Skull Pins are used in open and percutaneous craniotomies such as biopsies, thalamotomies and electrode implants; and in spinal surgeries when rigid skeletal fixation is necessary. The pins are also indicated for use during intra-operative use within a MR environment rated up to and including a 1.5 Tesla magnetic field.
The target population for the limited artifact skull pins is that part of the population that requires the use of a head holder to fixate their head and neck in a particular position during surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073163 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073163: Limited Artifact Skull Pin, Model 0107.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073163
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