510(k) Report

510(k) · Cleared

Cleared

Aesculap Absorbable Craniofix

K040080510(k) TraditionalCleared Mar 31, 200476-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

Aesculap, Inc. · GXR Cover, Burr Hole

Cleared on Mar 31, 2004 as substantially equivalent to K031654 (Synthes (Usa), 2003) and 2 other predicates after a 76-day review. Its family tree reaches back 1 generation to 2001. 8 later devices descend from it.

Decided
Mar 31, 2004
Review
76 days
Class
Class II
Product code
GXR
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K002334 (2001). 3 ancestors in all. 8 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2002: 1 other ancestor2010: 2 descendants cleared2013: 2 descendants cleared2023: 1 descendant cleared2020: 1 descendant cleared2024: 1 descendant cleared2016: 1 descendant clearedK002334 · Macroporens Craniloc · Macropore Biosurgery, Inc. · 2001200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 3 descendants K002334 · Macroporens Craniloc · Macropore Biosurgery, Inc. · 20010
  1. Root · 1 generation backK002334 Macroporens CranilocMacropore Biosurgery, Inc. · 2001
  2. This deviceK040080 Aesculap Absorbable CraniofixAesculap, Inc. · 2004
  3. Descendant · cites it directly · 4 of its ownK101235 Cranial Loop Cranial Bone Fixation SystemNeos Surgery S.L · 2010
  4. Descendant · 2 generations on · 3 of its ownK132044 Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone…Neos Surgery S.L · 2013
  5. Descendant · 3 generations on · 1 of its ownK160739 Cranial COVERNeos Surgery S.L · 2016
  6. Descendant · cites it directly · 1 of its ownK130309 Rapidflap LS Cranial Flap Fixation SystemBiomet Microfixation · 2013
  7. Descendant · 3 generations on · 0 of its ownK240137 Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone…Neos Surgery S.L · 2024

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2010: 22013: 22016: 12020: 12023: 12024: 1
2010high 2 (2010) · low 0 (2011)2026

Most influential descendants

Showing 5 of 8 · See all
  • K101235Cranial Loop Cranial Bone Fixation SystemNeos Surgery S.L · 2010 · cites it directly4descendants
  • K132044Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation SystemNeos Surgery S.L · 2013 · 2 generations on3descendants
  • K160739Cranial COVERNeos Surgery S.L · 2016 · 3 generations on1descendant
  • K130309Rapidflap LS Cranial Flap Fixation SystemBiomet Microfixation · 2013 · cites it directly1descendant
  • K240137Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemNeos Surgery S.L · 2024 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002334Macroporens CranilocMacropore Biosurgery, Inc.2001—
0 (this device)K040080Aesculap Absorbable CraniofixAesculap, Inc.2004—
+1K101235Cranial Loop Cranial Bone Fixation SystemNeos Surgery S.L2010—
+2K132044Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation…Neos Surgery S.L2013—
+3K160739Cranial COVERNeos Surgery S.L2016—
+1K130309Rapidflap LS Cranial Flap Fixation SystemBiomet Microfixation2013—
+3K240137Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemNeos Surgery S.L2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201020
201320
201610
202010
202310
202410
FIG. 1 — Lineage of K040080, 2001–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253447 Montage Flowable Settable, Resorbable Bone…score 13.7 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K031654Synthes Resorbable Cranial Clamp, (Modified)
Summary page 1
…nioFix as described in this premarket notification is substantially equivalent to these predicate devices: * Synthes Resorbable Cranial Clamp (modified) (K03 1654) * Synthes Resorbable Cranial Clamp (KO21408 and K031654) * MacroPore CraniLoc NS (K002334)…
Synthes (Usa)2003—
*K021408Resorbable Cranial ClampsSynthes (Usa)2002—
*K002334Macroporens Craniloc
Summary page 1
…Synthes Resorbable Cranial Clamp (modified) (K03 1654) * Synthes Resorbable Cranial Clamp (KO21408 and K031654) * MacroPore CraniLoc NS (K002334) 4 DEPARTMENT OF HEALTH & HUMAN SERVICES…
Macropore Biosurgery, Inc.2001—

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K101235Cranial Loop Cranial Bone Fixation SystemNeos Surgery S.L20104
K130309Rapidflap LS Cranial Flap Fixation SystemBiomet Microfixation20131
K091692Aesculap Peek CraniofixAesculap, Inc.20100

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 3 ancestors has a recall.
  • Of its descendants, K101235 (Neos Surgery S.L, 2010) has gone furthest, with 4 descendants of its own.

How does its category compare?

All GXR devices

GXR Cover, Burr Hole: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GXR

1in 2024

2007: 12010: 22013: 42014: 22016: 22018: 22020: 22023: 12024: 12026 (partial year): 1
2007high 4 (2013) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXR

116in 2013

2013: 116 days median
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

2007: 32008: 22010: 12011: 42012: 42013: 42014: 22015: 72016: 72017: 72018: 452019: 282020: 162021: 282022: 132023: 112024: 32025: 10
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—03
20080—02
20090—00
20102—01
20110—04
20120—04
2013411604
20142—02
20150—07
20162—07
20170—07
20182—045
20190—028
20202—016
20210—028
20220—013
20231—011
20241—03
20250—010
20261—0—

What is it indicated for?

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

Indications for use as stated in the FDA summary.

More from Aesculap, Inc.

208 FDA decisions under this applicant name. See the company

  • K260044Ventricular Catheters, Thomale CatheterAesculap, Inc. · 2026
  • K242762Aesculap Aicon® Series Container SystemAesculap, Inc. · 2025
  • K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetAesculap, Inc. · 2024
  • K223596SQ.line KERRISONAesculap, Inc. · 2023
  • K214041Aesculap AICON ContainerAesculap, Inc. · 2022

Recent decisions in GXR

The GXR category page

  • K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc. · 2026
  • K240137Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemNeos Surgery S.L · 2024
  • K221606Absorbable Cranial Flap Fixation SystemChendu Medart Medical Scientific Co., Ltd. · 2023
  • K192310Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd. · 2020
  • K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLC · 2020

https://510kreport.com/device/K040080 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040080: Aesculap Absorbable Craniofix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040080

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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