510(k) · Cleared
ClearedCranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neos Surgery S.L · GXR Cover, Burr Hole
Cleared on Sep 30, 2013 as substantially equivalent to K101235 (Neos Surgery S.L, 2010) after a 90-day review. Its family tree reaches back 3 generations to 2001. 3 later devices descend from it.
- Decided
- Sep 30, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- GXR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002334 (2001). 7 ancestors in all, the oldest K972332 (1998). 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK002334 Macroporens CranilocMacropore Biosurgery, Inc. · 2001
- 2 generations backK040080 Aesculap Absorbable CraniofixAesculap, Inc. · 2004
- 1 generation backK101235 Cranial Loop Cranial Bone Fixation SystemNeos Surgery S.L · 2010
- This deviceK132044 Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone…Neos Surgery S.L · 2013
- Descendant · cites it directly · 1 of its ownK160739 Cranial COVERNeos Surgery S.L · 2016
- Descendant · cites it directly · 0 of its ownK240137 Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone…Neos Surgery S.L · 2024
- Descendant · cites it directly · 0 of its ownK192310 Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd. · 2020
Most influential descendants
Showing 3 of 3 · See all- K160739Cranial COVERNeos Surgery S.L · 2016 · cites it directly1descendant
- K240137Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemNeos Surgery S.L · 2024 · cites it directly0descendants
- K192310Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002334 | Macroporens Craniloc | Macropore Biosurgery, Inc. | 2001 | — |
| −2 | K040080 | Aesculap Absorbable Craniofix | Aesculap, Inc. | 2004 | — |
| −1 | K101235 | Cranial Loop Cranial Bone Fixation System | Neos Surgery S.L | 2010 | — |
| 0 (this device) | K132044 | Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation… | Neos Surgery S.L | 2013 | — |
| +1 | K160739 | Cranial COVER | Neos Surgery S.L | 2016 | — |
| +1 | K240137 | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System | Neos Surgery S.L | 2024 | — |
| +1 | K192310 | Flap Fixator, Burr Hole Cover | Ossaware Biotech Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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 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
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 | Decided |
|---|---|---|---|
| * | K101235 | Cranial Loop Cranial Bone Fixation SystemSummary page 4…ussion: The line extension for the Cranial LOOP L and Cranial LOOP XL has the following similarities to the previously cleared Cranial LOOP Cranial Bone Fixation System- K101235: * has the same indicated use. " uses the same operating principle, * incorporates the same basic device… | 2010 |
What descends from it? (3)
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 12 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K160739 (Neos Surgery S.L, 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GXR devicesGXR Cover, Burr Hole: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · GXR
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GXR
116in 2013
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 4 | 116 | 0 | 4 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 2 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 2 | — | 0 | 45 |
| 2019 | 0 | — | 0 | 28 |
| 2020 | 2 | — | 0 | 16 |
| 2021 | 0 | — | 0 | 28 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 1 | — | 0 | 11 |
| 2024 | 1 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Cranial LOOP Cranial Bone Fixation Systems: Cranial LOOP, Cranial LOOP L and Cranial LOOP XL, are long-term implantable devices indicated for post-craniotamy bone flap fixation.
In cranial bone fixation procedures, the Cranial LOOP (FCO50000) and Cranial LOOP L (FCO5O1 00) are for use within the calvarial gap while the Cranial LOOP XL (FC050200) is to be used for covering a standard 14 mm cranial burr hale only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132044 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132044: Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone 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/K132044
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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