510(k) · Cleared

Cleared

Craniofix and CRANIOFIX2 Titanium Clamp System

K040864510(k) TraditionalCleared Jun 17, 200476-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

Aesculap · GXN Plate, Cranioplasty, Preformed, Non-Alterable

Cleared on Jun 17, 2004 as substantially equivalent to K972332 (Aesculap, Inc., 1998) and 1 other predicate after a 76-day review. Its family tree reaches back 1 generation to 1994. 67 later devices descend from it.

Decided: Jun 17, 2004
Review: 76 days
Class: Class II
Product code: GXN
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K923705 (1994). 2 ancestors in all. 67 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK923705 Aesculap Craniofacial Titanium Plates and ScrewsAesculap, Inc. · 1994
This deviceK040864 Craniofix and CRANIOFIX2 Titanium Clamp SystemAesculap · 2004
Descendant · cites it directly · 62 of its ownK062857 KLS Martin Quick DiscKLS Martin L.P. · 2006
Descendant · 2 generations on · 61 of its ownK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
Descendant · 3 generations on · 45 of its ownK151983 KLS Martin LSS Plating SystemKLS Martin L.P. · 2016
Descendant · 4 generations on · 39 of its ownK202889 Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021
Descendant · 5 generations on · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022

Showing 5 of 67 descendants. See all descendants

Descendants cleared per year

2006high 14 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 67 · See all

K062857KLS Martin Quick DiscKLS Martin L.P. · 2006 · cites it directly62descendants
K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007 · 2 generations on61descendants
K151983KLS Martin LSS Plating SystemKLS Martin L.P. · 2016 · 3 generations on45descendants
K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021 · 4 generations on39descendants
K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · 5 generations on36descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K923705	Aesculap Craniofacial Titanium Plates and Screws	Aesculap, Inc.	1994	—
0 (this device)	K040864	Craniofix and CRANIOFIX2 Titanium Clamp System	Aesculap	2004	—
+1	K062857	KLS Martin Quick Disc	KLS Martin L.P.	2006	—
+2	K070169	KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile	KLS Martin L.P.	2007	—
+3	K151983	KLS Martin LSS Plating System	KLS Martin L.P.	2016	—
+4	K202889	Able Medical Devices Valkyrie Thoracic Fixation System	Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices	2021	—
+5	K220782	IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System…	Alphatec Spine, Inc.	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	2	0
2007	1	0
2009	1	0
2011	1	0
2012	2	0
2013	1	0
2014	4	0
2015	2	0
2016	2	0
2021	3	0
2022	3	0
2023	8	0
2024	12	0
2025	14	0
2026	11	0

FIG. 1 — Lineage of K040864, 1994–2026Source: 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? (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	Applicant	Decided	Recalls
*	K972332	Aesculap Craniofix Titanium Clamp System Summary page 2 …ded indications for use described in this premarket notification are substantially equivalent to these predicate devices: * Aesculap CranioFix Titanium Clamp System (K972332) * Aesculap Craniofacial Implant Set (K923705) 5 A DEPAR…	Aesculap, Inc.	1998	—
*	K923705	Aesculap Craniofacial Titanium Plates and Screws Summary page 2 …t notification are substantially equivalent to these predicate devices: * Aesculap CranioFix Titanium Clamp System (K972332) * Aesculap Craniofacial Implant Set (K923705) 5 A DEPARTMENT OF HEALTH & HUMAN SERVICES…	Aesculap, Inc.	1994	—

Also cleared against K972332: 7 other devices →

What descends from it? (67)

See all 67

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K062857	KLS Martin Quick Disc	KLS Martin L.P.	2006	62
K122353	Crainfix 2 Titanium Clamp System	Aesculap, Inc.	2012	1
K063017	Aesculap Sternumfix Sternal Closure System	Aesculap, Inc.	2006	1
K130447	Speedy Flap System	Jeil Medical Corporation	2014	0

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?

None of the 2 ancestors has a recall.
Of its descendants, K062857 (KLS Martin L.P., 2006) has gone furthest, with 62 descendants of its own.
7 other devices also cite its predicate K972332.

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?

Aesculap's CranioFix and CranioFix2 System are intended for use in the fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040864 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040864: Craniofix and CRANIOFIX2 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/K040864

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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