510(k) · Cleared
ClearedLeibinger Quik Disk Titanium Clamp System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cleared on Feb 22, 2000 as substantially equivalent to K972332 (Aesculap, Inc., 1998) and 2 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1998. 6 later devices descend from it.
- Decided
- Feb 22, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- GXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K971252 (1998). 4 ancestors in all, the oldest K972332 (1998). 6 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK971252 Sevrain Cranial ClampIkonos Corp. · 1998
- 1 generation backK991029 Rapidflap Cranial ClampWalter Lorenz Surgical, Inc. · 1999
- This deviceK993990 Leibinger Quik Disk Titanium Clamp SystemStryker Instruments · 2000
- 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 · 2 generations on · 0 of its ownK082175 Mofication to: Modified Plate Design for Bioplate Zip Craniotomy…Bioplate, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK051293 Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed…Ceremed, Inc. · 2005
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
- K082175Mofication to: Modified Plate Design for Bioplate Zip Craniotomy FixationBioplate, Inc. · 2008 · 2 generations on0descendants
- K051293Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation SystemCeremed, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971252 | Sevrain Cranial Clamp | Ikonos Corp. | 1998 | — |
| −1 | K991029 | Rapidflap Cranial Clamp | Walter Lorenz Surgical, Inc. | 1999 | — |
| 0 (this device) | K993990 | Leibinger Quik Disk Titanium Clamp System | Stryker Instruments | 2000 | — |
| +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 | — |
| +2 | K082175 | Mofication to: Modified Plate Design for Bioplate Zip Craniotomy Fixation | Bioplate, Inc. | 2008 | — |
| +2 | K051293 | Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation… | Ceremed, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 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.
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? (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 |
|---|---|---|---|
| * | K972332 | Aesculap Craniofix Titanium Clamp SystemSummary page 1…raniotomy procedure. Substantial Equivalence The Leibinger Quik Disk Titanium Clamp System is substantially equivalent to the Aesculap Craniofix Titanium Clamp System (K972332), the Synthes Cranial Flap Twist Clamp (K991860) and the Walter Lorenz RapidFlap Cranial Clamp (K991029). of Wia… | 1998 |
| * | K991860 | Synthes Cranial Flap Twist ClampSummary page 1…he Leibinger Quik Disk Titanium Clamp System is substantially equivalent to the Aesculap Craniofix Titanium Clamp System (K972332), the Synthes Cranial Flap Twist Clamp (K991860) and the Walter Lorenz RapidFlap Cranial Clamp (K991029). of Wiairy H&icy, %, ] {é DEPARTMENT OF HEALTH & HUMAN… | 1999 |
| * | K991029 | Rapidflap Cranial ClampSummary page 1…ally equivalent to the Aesculap Craniofix Titanium Clamp System (K972332), the Synthes Cranial Flap Twist Clamp (K991860) and the Walter Lorenz RapidFlap Cranial Clamp (K991029). of Wiairy H&icy, %, ] {é DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administra… | 1999 |
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K013050 (Bioplate, Inc., 2001) has gone furthest, with 4 descendants of its own.
- 7 other devices also cite its predicate K972332.
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?
The Leibinger Quik Disk Titanium Clamp System 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/K993990 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993990: Leibinger Quik Disk Titanium Clamp System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993990
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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