510(k) · Cleared
Recalled · Class II · 2015Synthes Cranial Flap Tube Clamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cleared on Jul 20, 1999 after a 35-day review. The FDA summary names its predicate without a number. 6 later devices descend from it. It has been recalled once.
- Decided
- Jul 20, 1999
- Review
- 35 days
- Class
- Class II
- Product code
- GXN
- Recalls
- 1
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK992000 Synthes Cranial Flap Tube ClampSynthes (Usa) · 1999
- Descendant · cites it directly · 4 of its ownK013050 The Bioplate Zip Craniotomy Fixation SystemBioplate, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK020088 Modification of the Bioplate Zip Craniotomy Fixation SystemBioplate, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK070901 Modified Plate Design for Bioplate Zip Craniotomy Fixation SystemBioplate, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK192702 DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK082175 Mofication to: Modified Plate Design for Bioplate Zip Craniotomy…Bioplate, Inc. · 2008
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K013050The Bioplate Zip Craniotomy Fixation SystemBioplate, Inc. · 2001 · cites it directly4descendants
- K020088Modification of the Bioplate Zip Craniotomy Fixation SystemBioplate, Inc. · 2002 · cites it directly2descendants
- K070901Modified Plate Design for Bioplate Zip Craniotomy Fixation SystemBioplate, Inc. · 2007 · 2 generations on1descendant
- K192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC · 2020 · cites it directly0descendants
- K082175Mofication to: Modified Plate Design for Bioplate Zip Craniotomy FixationBioplate, Inc. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992000 | Synthes Cranial Flap Tube Clamp | Synthes (Usa) | 1999 | — |
| +1 | K013050 | The Bioplate Zip Craniotomy Fixation System | Bioplate, Inc. | 2001 | — |
| +1 | K020088 | Modification of the Bioplate Zip Craniotomy Fixation System | Bioplate, Inc. | 2002 | — |
| +2 | K070901 | Modified Plate Design for Bioplate Zip Craniotomy Fixation System | Bioplate, Inc. | 2007 | — |
| +1 | K192702 | DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional | Synthes (USA) Products, LLC | 2020 | — |
| +2 | K082175 | Mofication to: Modified Plate Design for Bioplate Zip Craniotomy Fixation | Bioplate, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2020 | 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 GXN? 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 GXN device
- #1 K260709 ClearFit Ti Ring 14mm (171750);ClearFit Ti…score 13.7 · 8 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 |
|---|---|---|---|
| * | — | Aesculap's Craniofix Titanium Clamp System Named without a submission number |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 31, 2015 | Class II | Z-2811-2015 | Labeling False and Misleading | The Synthes Cranial Flap Tube Clamp and Crimping Device for Cranial Tube Clamp had been labeled MR Safe although they do not have the testing protocols currently required to designate them as MR Safe. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K013050 (Bioplate, Inc., 2001) has gone furthest, with 4 descendants of its own.
How does its category compare?
All GXN devicesGXN Plate, Cranioplasty, Preformed, Non-Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GXN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXN
69in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXN
6in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXN
24in 2025
MAUDE reports naming product code GXN, 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 | 2 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 17 |
| 2009 | 0 | — | 0 | 17 |
| 2010 | 0 | — | 0 | 23 |
| 2011 | 2 | — | 0 | 20 |
| 2012 | 3 | 102 | 0 | 29 |
| 2013 | 1 | — | 0 | 57 |
| 2014 | 2 | — | 0 | 60 |
| 2015 | 2 | — | 0 | 47 |
| 2016 | 1 | — | 0 | 35 |
| 2017 | 2 | — | 0 | 74 |
| 2018 | 3 | 199 | 6 | 56 |
| 2019 | 0 | — | 0 | 54 |
| 2020 | 5 | 33 | 0 | 63 |
| 2021 | 3 | 69 | 0 | 63 |
| 2022 | 2 | — | 0 | 57 |
| 2023 | 1 | — | 0 | 32 |
| 2024 | 1 | — | 0 | 35 |
| 2025 | 2 | — | 0 | 24 |
| 2026 | 4 | 193 | 0 | — |
What is it indicated for?
Synthes Cranial Flap Tube Clamp is intended to reattach a cranial
bone flap to the surrounding Cranium after a craniotomy procedure.
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/K992000 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992000: Synthes Cranial Flap Tube Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992000
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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