510(k) · Cleared
ClearedCranial COVER
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 Jun 12, 2016 as substantially equivalent to K983885 (Howmedica, Inc., 1999) and 2 other predicates after an 87-day review. Its family tree reaches back 4 generations to 2001. 1 later device descends from it.
- Decided
- Jun 12, 2016
- Review
- 87 days
- Class
- Class II
- Product code
- GXR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K002334 (2001). 11 ancestors in all, the oldest K972332 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK002334 Macroporens CranilocMacropore Biosurgery, Inc. · 2001
- 3 generations backK040080 Aesculap Absorbable CraniofixAesculap, Inc. · 2004
- 2 generations backK101235 Cranial Loop Cranial Bone Fixation SystemNeos Surgery S.L · 2010
- 1 generation backK132044 Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone…Neos Surgery S.L · 2013
- This deviceK160739 Cranial COVERNeos Surgery S.L · 2016
- Descendant · cites it directly · 0 of its ownK192310 Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd. · 2020
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −4 | K002334 | Macroporens Craniloc | Macropore Biosurgery, Inc. | 2001 | — |
| −3 | K040080 | Aesculap Absorbable Craniofix | Aesculap, Inc. | 2004 | — |
| −2 | 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 | — |
| 0 (this device) | K160739 | Cranial COVER | Neos Surgery S.L | 2016 | — |
| +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 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K983885 | Burr Hole Covers, Craniomaxillofacial PlatesSummary page 4…ver Regulatory Class: 882.5250 Burr hole cover Classification Panel: Neurology Product Codes: GXR Predicate Device(s): Leibinger Burr Hole Covers – K983885 Neuropace Burr Hole Cover – K123163 Cranial LOOP XL – K132044 Devic… | 1999 |
| * | K123163 | Neuropace Burr Hole Cover Model 8110Summary page 4…Panel: Neurology Product Codes: GXR Predicate Device(s): Leibinger Burr Hole Covers – K983885 Neuropace Burr Hole Cover – K123163 Cranial LOOP XL – K132044 Device Description The Cranial COVER is a postoperative biocompatible… | 2013 |
| * | K132044 | Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation SystemSummary page 4…evice(s): Leibinger Burr Hole Covers – K983885 Neuropace Burr Hole Cover – K123163 Cranial LOOP XL – K132044 Device Description The Cranial COVER is a postoperative biocompatible cranial burr hole cover system. It fits into most common… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192310 | Flap Fixator, Burr Hole Cover | 2020 | 0 |
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 15 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K192310 (Ossaware Biotech Co., Ltd., 2020) has gone furthest, with 0 descendants 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. 2016, 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 COVER is intended for use to cover burr holes resulting from cranial surgery. With the available sizes, burr holes with an epicranial diameter between 10 and 14 mm, made with standard perforators or with spherical drills, can be covered.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160739 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160739: Cranial COVER.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160739
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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