510(k) · Cleared
ClearedSynthes (Usa) Rapid Resorbable Cranial Clamp
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 Sep 8, 2004 after an 85-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Sep 8, 2004
- Review
- 85 days
- Class
- Class II
- Product code
- GXR
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK041611 Synthes (Usa) Rapid Resorbable Cranial ClampSynthes (Usa) · 2004
- Descendant · cites it directly · 1 of its ownK130309 Rapidflap LS Cranial Flap Fixation SystemBiomet Microfixation · 2013
- Descendant · cites it directly · 1 of its ownK073115 OrthomeshSynthes (Usa) · 2008
- Descendant · 2 generations on · 0 of its ownK221606 Absorbable Cranial Flap Fixation SystemChendu Medart Medical Scientific Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK180821 TruMatch Graft Cage - Long BoneSynthes (Usa), LLC · 2018
- Descendant · cites it directly · 0 of its ownK123633 TRS Cranial Bone Void Filler (TRS C-BVF)Tissue Regeneration Systems, Inc. · 2013
Most influential descendants
Showing 5 of 5 · See all- K130309Rapidflap LS Cranial Flap Fixation SystemBiomet Microfixation · 2013 · cites it directly1descendant
- K073115OrthomeshSynthes (Usa) · 2008 · cites it directly1descendant
- K221606Absorbable Cranial Flap Fixation SystemChendu Medart Medical Scientific Co., Ltd. · 2023 · 2 generations on0descendants
- K180821TruMatch Graft Cage - Long BoneSynthes (Usa), LLC · 2018 · 2 generations on0descendants
- K123633TRS Cranial Bone Void Filler (TRS C-BVF)Tissue Regeneration Systems, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041611 | Synthes (Usa) Rapid Resorbable Cranial Clamp | Synthes (Usa) | 2004 | — |
| +1 | K130309 | Rapidflap LS Cranial Flap Fixation System | Biomet Microfixation | 2013 | — |
| +1 | K073115 | Orthomesh | Synthes (Usa) | 2008 | — |
| +2 | K221606 | Absorbable Cranial Flap Fixation System | Chendu Medart Medical Scientific Co., Ltd. | 2023 | — |
| +2 | K180821 | TruMatch Graft Cage - Long Bone | Synthes (Usa), LLC | 2018 | — |
| +1 | K123633 | TRS Cranial Bone Void Filler (TRS C-BVF) | Tissue Regeneration Systems, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 2 | 0 |
| 2018 | 1 | 0 |
| 2023 | 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 | |
| * | — | Biomet Lactosorb RapidFlap Named without a submission number |
What descends from it? (5)
3 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, K130309 (Biomet Microfixation, 2013) has gone furthest, with 1 descendant 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 Rapid Resorbable Cranial Clamp is indicated for covering burr holes and for fixation of cranial bone flaps in adult and pediatric populations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041611: Synthes (Usa) Rapid Resorbable Cranial Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041611
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