510(k) · Cleared

Cleared

Stryker Leibinger Cranial Fixation System

K030378510(k) TraditionalCleared Mar 20, 200343-day reviewClass II21 CFR 882.5330

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stryker Instruments · GXN Plate, Cranioplasty, Preformed, Non-Alterable

Cleared on Mar 20, 2003 as substantially equivalent to K993990 (Stryker Instruments, 2000) and 3 other predicates after a 43-day review. Its family tree reaches back 3 generations to 1998.

Decided: Mar 20, 2003
Review: 43 days
Class: Class II
Product code: GXN
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K971252 (1998). 5 ancestors in all, the oldest K972332 (1998). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK971252 Sevrain Cranial ClampIkonos Corp. · 1998
2 generations backK991029 Rapidflap Cranial ClampWalter Lorenz Surgical, Inc. · 1999
1 generation backK993990 Leibinger Quik Disk Titanium Clamp SystemStryker Instruments · 2000
This deviceK030378 Stryker Leibinger Cranial Fixation SystemStryker Instruments · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K971252	Sevrain Cranial Clamp	Ikonos Corp.	1998	—
−2	K991029	Rapidflap Cranial Clamp	Walter Lorenz Surgical, Inc.	1999	—
−1	K993990	Leibinger Quik Disk Titanium Clamp System	Stryker Instruments	2000	—
0 (this device)	K030378	Stryker Leibinger Cranial Fixation System	Stryker Instruments	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	0

FIG. 1 — Lineage of K030378, 1998–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	K993990	Leibinger Quik Disk Titanium Clamp System Summary page 1 …alence EQUIVALENT PRODUCTS: The Stryker Leibinger Cranial Fixation System is substantially equivalent to the Leibinger Quik Disk Titanium Clamp System (K993990), Aesculap Craniofix Titanium Clamp System (K972332), the Synthes Cranial Flap Twist Clamp (K991860) and the Walter L…	Stryker Instruments	2000	—
*	K972332	Aesculap Craniofix Titanium Clamp System Summary page 1 …ger Cranial Fixation System is substantially equivalent to the Leibinger Quik Disk Titanium Clamp System (K993990), Aesculap Craniofix Titanium Clamp System (K972332), the Synthes Cranial Flap Twist Clamp (K991860) and the Walter Lorenz RapidFlap Cranial Clamp (K991029). Wade T. Rbtkosk…	Aesculap, Inc.	1998	—
*	K991860	Synthes Cranial Flap Twist Clamp Summary page 1 …t to the Leibinger Quik Disk Titanium Clamp System (K993990), Aesculap Craniofix Titanium Clamp System (K972332), the Synthes Cranial Flap Twist Clamp (K991860) and the Walter Lorenz RapidFlap Cranial Clamp (K991029). Wade T. Rbtkoskie Associate Manager RA QA Stryker Instruments Leibing…	Synthes (Usa)	1999	—
*	K991029	Rapidflap Cranial Clamp Summary page 1 …(K993990), Aesculap Craniofix Titanium Clamp System (K972332), the Synthes Cranial Flap Twist Clamp (K991860) and the Walter Lorenz RapidFlap Cranial Clamp (K991029). Wade T. Rbtkoskie Associate Manager RA QA Stryker Instruments Leibinger Division DEPARTMENT OF HEALTH…	Walter Lorenz Surgical, Inc.	1999	—

Also cleared against K993990: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 5 years and passes through 3 companies; a new generation was cleared every 10 months on median.
None of the 5 ancestors has a recall.
2 other devices also cite its predicate K993990.

How does its category compare?

All GXN devices

GXN Plate, Cranioplasty, Preformed, Non-Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GXN

2in 2025

2007high 5 (2020) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXN

69in 2021

2007high 199 (2018) · low 33 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GXN

6in 2018

2007high 6 (2018) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GXN

24in 2025

2007high 74 (2017) · low 3 (2007)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 Stryker Leibinger Cranial Fixation System is intended for the fixation of a cranial bone flap after a craniotomy. The implant could be applied in the craniotomy gap as well as in burr holes.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030378 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030378: Stryker Leibinger Cranial Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030378

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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