510(k) · Cleared

Cleared

Aesculap Peek Craniofix

K091692510(k) TraditionalCleared Aug 12, 2010428-day reviewClass II21 CFR 882.5250

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

Cleared on Aug 12, 2010 as substantially equivalent to K040080 (Aesculap, Inc., 2004) after a 428-day review. Its family tree reaches back 2 generations to 2001.

Decided: Aug 12, 2010
Review: 428 days
Class: Class II
Product code: GXR
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K002334 (2001). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK002334 Macroporens CranilocMacropore Biosurgery, Inc. · 2001
1 generation backK040080 Aesculap Absorbable CraniofixAesculap, Inc. · 2004
This deviceK091692 Aesculap Peek CraniofixAesculap, Inc. · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K002334	Macroporens Craniloc	Macropore Biosurgery, Inc.	2001	—
−1	K040080	Aesculap Absorbable Craniofix	Aesculap, Inc.	2004	—
0 (this device)	K091692	Aesculap Peek Craniofix	Aesculap, Inc.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0

FIG. 1 — Lineage of K091692, 2001–2010Source: 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 GXR? 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 GXR device

#1 K253447 Montage Flowable Settable, Resorbable Bone…score 13.7 · 10 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? (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	Applicant	Decided	Recalls
*	K040080	Aesculap Absorbable Craniofix Summary page 1 …sculap PEEK CranioFix as described in this premarket notification is substantially equivalent to the following predicate device: Aesculap Absorbable Craniofix (K040080) DEVICE DESCRIPTION Aesculap's PEEK CranioFix consists of two absorbable discs connected by a suture loop. INDICATIONS FOR USE…	Aesculap, Inc.	2004	—

Also cleared against K040080: 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 9 years and passes through 2 companies; a new generation was cleared every 6.4 years on median.
None of the 4 ancestors has a recall.
2 other devices also cite its predicate K040080.

How does its category compare?

All GXR devices

GXR Cover, Burr Hole: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · GXR

1in 2024

2007high 4 (2013) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXR

116in 2013

2007high 116 (2013)2026

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

Recalls per year · GXR

No recall names GXR since 2007.

Adverse event reports per year · GXR

10in 2025

2007high 45 (2018) · low 0 (2009)2025

MAUDE reports naming product code GXR, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	3
2008	0	—	2
2009	0	—	0
2010	2	—	1
2011	0	—	4
2012	0	—	4
2013	4	116	4
2014	2	—	2
2015	0	—	7
2016	2	—	7
2017	0	—	7
2018	2	—	45
2019	0	—	28
2020	2	—	16
2021	0	—	28
2022	0	—	13
2023	1	—	11
2024	1	—	3
2025	0	—	10
2026	1	—	—

What is it indicated for?

Aesculap's PEEK CranioFix is intended for fixation of cranial bone flaps.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091692 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091692: Aesculap Peek Craniofix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091692

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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