510(k) · Cleared
ClearedTZ SKULL PIN Adult
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tz Medical, Inc. · HBL Holder, Head, Neurosurgical (Skull Clamp)
Cleared on Feb 23, 2017 as substantially equivalent to K923789 (Ohio Medical Instrument Co., Inc., 1993) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- Feb 23, 2017
- Review
- 90 days
- Class
- Class II
- Product code
- HBL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K923789 (1993). 2 ancestors in all. 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 deviceK163322 TZ SKULL PIN AdultTz Medical, Inc. · 2017
- 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) | K163322 | TZ SKULL PIN Adult | Tz Medical, Inc. | 2017 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
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? (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 |
|---|---|---|---|
| * | K923789 | Mayfield Adult Disposable Skull PinSummary page 4…) Classification: Class Il, per 21 CFR 882.4460 Panel: Neurology Product Code: HBL Predicate Device: Product 510(k) Number Mayfield Adult Disposable Steel Skull Pins K923789 Mayfield Adult Disposable Steel Skull Pins K932860 Device Description: The TZ Skull Pin is a sterile cervical traction skull pin… | 1993 |
| * | K932860 | Mayfield Adult Disposable Skull PinSummary page 4…nel: Neurology Product Code: HBL Predicate Device: Product 510(k) Number Mayfield Adult Disposable Steel Skull Pins K923789 Mayfield Adult Disposable Steel Skull Pins K932860 Device Description: The TZ Skull Pin is a sterile cervical traction skull pin manufactured from implant grade 316L stainless ste… | 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. 2017, 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 TZ Medical skull pin is placed in a clamp and is applied to the patient's skull to hold their head and neck securely in a
particular position when rigid fixation is desired.
The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is
necessary.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163322 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163322: TZ SKULL PIN Adult.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163322
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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