510(k) · Cleared
ClearedCranial Loop 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 Oct 25, 2010 as substantially equivalent to K010361 (Medtronic PS Medical, 2001) and 2 other predicates after a 175-day review. Its family tree reaches back 2 generations to 2001. 4 later devices descend from it.
- Decided
- Oct 25, 2010
- Review
- 175 days
- Class
- Class II
- Product code
- GXR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K002334 (2001). 6 ancestors in all, the oldest K972332 (1998). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK002334 Macroporens CranilocMacropore Biosurgery, Inc. · 2001
- 1 generation backK040080 Aesculap Absorbable CraniofixAesculap, Inc. · 2004
- This deviceK101235 Cranial Loop Cranial Bone Fixation SystemNeos Surgery S.L · 2010
- Descendant · cites it directly · 3 of its ownK132044 Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone…Neos Surgery S.L · 2013
- Descendant · 2 generations on · 1 of its ownK160739 Cranial COVERNeos Surgery S.L · 2016
- Descendant · 2 generations on · 0 of its ownK240137 Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone…Neos Surgery S.L · 2024
- Descendant · 2 generations on · 0 of its ownK192310 Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd. · 2020
Most influential descendants
Showing 4 of 4 · See all- K132044Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation SystemNeos Surgery S.L · 2013 · cites it directly3descendants
- K160739Cranial COVERNeos Surgery S.L · 2016 · 2 generations on1descendant
- K240137Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemNeos Surgery S.L · 2024 · 2 generations on0descendants
- K192310Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd. · 2020 · 2 generations on0descendants
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) | K101235 | Cranial Loop Cranial Bone Fixation System | Neos Surgery S.L | 2010 | — |
| +1 | K132044 | Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation… | Neos Surgery S.L | 2013 | — |
| +2 | K160739 | Cranial COVER | Neos Surgery S.L | 2016 | — |
| +2 | K240137 | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System | Neos Surgery S.L | 2024 | — |
| +2 | 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 |
|---|---|---|
| 2013 | 1 | 0 |
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K010361 | Medtronic PS Medical Invisx Cranial Fixation System, Model 60100-60900Summary page 1…882.5250 Burr hole cover, 882.5330 Preformed -nonalterable cranioplasty plate Product Codes: GXR, GXN Predicate Device(s): INVISx-K010361, CranioFix- K040080, CranioFix Titanium- K972332 Device Description:~ The Cranial LOOP Cranial Bone Fixat… | 2001 |
| * | K040080 | Aesculap Absorbable CraniofixSummary page 1…hole cover, 882.5330 Preformed -nonalterable cranioplasty plate Product Codes: GXR, GXN Predicate Device(s): INVISx-K010361, CranioFix- K040080, CranioFix Titanium- K972332 Device Description:~ The Cranial LOOP Cranial Bone Fixation System is a bioc… | 2004 |
| * | K972332 | Aesculap Craniofix Titanium Clamp SystemSummary page 1…cranioplasty plate Product Codes: GXR, GXN Predicate Device(s): INVISx-K010361, CranioFix- K040080, CranioFix Titanium- K972332 Device Description:~ The Cranial LOOP Cranial Bone Fixation System is a biocompatible, postoperative cranial bone fixation system… | 1998 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132044 | Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation System | 2013 | 3 |
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 3 companies; a new generation was cleared every 6.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K132044 (Neos Surgery S.L, 2013) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K010361.
How does its category compare?
All GXR devicesGXR 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
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 System is a long-term implantable device indicated for post-craniotomy bone flap fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101235 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101235: Cranial Loop 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/K101235
Report an extraction error
Are you the manufacturer?
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