510(k) · Cleared
ClearedSynthes Resorbable Cranial Clamp, (Modified)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · GXR Cover, Burr Hole
Cleared on Aug 8, 2003 after a 72-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Aug 8, 2003
- Review
- 72 days
- Class
- Class II
- Product code
- GXR
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK031654 Synthes Resorbable Cranial Clamp, (Modified)Synthes (Usa) · 2003
- Descendant · cites it directly · 8 of its ownK040080 Aesculap Absorbable CraniofixAesculap, Inc. · 2004
- Descendant · 2 generations on · 4 of its ownK101235 Cranial Loop Cranial Bone Fixation SystemNeos Surgery S.L · 2010
- Descendant · 3 generations on · 3 of its ownK132044 Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone…Neos Surgery S.L · 2013
- Descendant · 4 generations on · 1 of its ownK160739 Cranial COVERNeos Surgery S.L · 2016
- Descendant · 2 generations on · 1 of its ownK130309 Rapidflap LS Cranial Flap Fixation SystemBiomet Microfixation · 2013
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K040080Aesculap Absorbable CraniofixAesculap, Inc. · 2004 · cites it directly8descendants
- K101235Cranial Loop Cranial Bone Fixation SystemNeos Surgery S.L · 2010 · 2 generations on4descendants
- K132044Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation SystemNeos Surgery S.L · 2013 · 3 generations on3descendants
- K160739Cranial COVERNeos Surgery S.L · 2016 · 4 generations on1descendant
- K130309Rapidflap LS Cranial Flap Fixation SystemBiomet Microfixation · 2013 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031654 | Synthes Resorbable Cranial Clamp, (Modified) | Synthes (Usa) | 2003 | — |
| +1 | K040080 | Aesculap Absorbable Craniofix | Aesculap, Inc. | 2004 | — |
| +2 | K101235 | Cranial Loop Cranial Bone Fixation System | Neos Surgery S.L | 2010 | — |
| +3 | K132044 | Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation… | Neos Surgery S.L | 2013 | — |
| +4 | K160739 | Cranial COVER | Neos Surgery S.L | 2016 | — |
| +2 | K130309 | Rapidflap LS Cranial Flap Fixation System | Biomet Microfixation | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | — | Synthes Resorbable Cranial Clamp Named without a submission number | |
| * | — | Medtronic INVISx Lock System Named without a submission number |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040080 | Aesculap Absorbable Craniofix | 2004 | 8 |
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?
- Of its descendants, K040080 (Aesculap, Inc., 2004) has gone furthest, with 8 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.
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?
Synthes Resorbable Cranial Clamp is intended for covering burr holes and for fixation of cranial bone flaps.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031654: Synthes Resorbable Cranial Clamp, (Modified).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031654
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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