510(k) · Cleared
ClearedFlap Fixator, Burr Hole Cover
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ossaware Biotech Co., Ltd. · GXR Cover, Burr Hole
Cleared on Jun 3, 2020 as substantially equivalent to K132044 (Neos Surgery S.L, 2013) and 1 other predicate after a 282-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Jun 3, 2020
- Review
- 282 days
- Class
- Class II
- Product code
- GXR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K002334 (2001). 12 ancestors in all, the oldest K972332 (1998). No later device cites it as a predicate yet.
- Root · 5 generations backK002334 Macroporens CranilocMacropore Biosurgery, Inc. · 2001
- 4 generations backK040080 Aesculap Absorbable CraniofixAesculap, Inc. · 2004
- 3 generations backK101235 Cranial Loop Cranial Bone Fixation SystemNeos Surgery S.L · 2010
- 2 generations backK132044 Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone…Neos Surgery S.L · 2013
- 1 generation backK160739 Cranial COVERNeos Surgery S.L · 2016
- This deviceK192310 Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002334 | Macroporens Craniloc | Macropore Biosurgery, Inc. | 2001 | — |
| −4 | K040080 | Aesculap Absorbable Craniofix | Aesculap, Inc. | 2004 | — |
| −3 | K101235 | Cranial Loop Cranial Bone Fixation System | Neos Surgery S.L | 2010 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2013 | 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? (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 | Decided |
|---|---|---|---|
| * | K132044 | Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation SystemSummary page 4…ce Legally marketed predicate devices to which substantial equivalence is claimed: ® Cranial Loop, Cranial Loop L And Cranial Loop XI And Cranial Bone Fixation System_K132044 ® Cranial Cover_K160739 K192310,… | 2013 |
| * | K160739 | Cranial COVERSummary page 4…icate devices to which substantial equivalence is claimed: ® Cranial Loop, Cranial Loop L And Cranial Loop XI And Cranial Bone Fixation System_K132044 ® Cranial Cover_K160739 K192310, 2 of 6… | 2016 |
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 19 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 2 other devices also cite its predicate K132044.
How does its category compare?
All GXR devicesGXR Cover, Burr Hole: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
CirFIX Cranial Bone Fixation System: Flap Fixator is intended for use to post-craniotomy bone flap fixation and the Burr Hole Cover is to be used for covering a single burr hole.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K192310 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192310: Flap Fixator, Burr Hole Cover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192310
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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