510(k) · Cleared
ClearedResorbable Cranial Clamps
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 Jul 29, 2002 after an 87-day review. The FDA summary names no predicate by number. 9 later devices descend from it.
- Decided
- Jul 29, 2002
- Review
- 87 days
- Class
- Class II
- Product code
- GXR
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK021408 Resorbable Cranial ClampsSynthes (Usa) · 2002
- 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 · cites it directly · 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 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021408 | Resorbable Cranial Clamps | Synthes (Usa) | 2002 | — |
| +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 | — |
| +1 | 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?
The FDA summary names no predicate by number.
What descends from it? (9)
2 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?
- 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 Clamps are 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/K021408 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021408: Resorbable Cranial Clamps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021408
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