510(k) · Cleared
ClearedAbsorbable Cranial Flap Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chendu Medart Medical Scientific Co., Ltd. · GXR Cover, Burr Hole
Cleared on Nov 21, 2023 as substantially equivalent to K130309 (Biomet Microfixation, 2013) after a 537-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Nov 21, 2023
- Review
- 537 days
- Class
- Class II
- Product code
- GXR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002334 (2001). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK002334 Macroporens CranilocMacropore Biosurgery, Inc. · 2001
- 2 generations backK040080 Aesculap Absorbable CraniofixAesculap, Inc. · 2004
- 1 generation backK130309 Rapidflap LS Cranial Flap Fixation SystemBiomet Microfixation · 2013
- This deviceK221606 Absorbable Cranial Flap Fixation SystemChendu Medart Medical Scientific Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002334 | Macroporens Craniloc | Macropore Biosurgery, Inc. | 2001 | — |
| −2 | K040080 | Aesculap Absorbable Craniofix | Aesculap, Inc. | 2004 | — |
| −1 | K130309 | Rapidflap LS Cranial Flap Fixation System | Biomet Microfixation | 2013 | — |
| 0 (this device) | K221606 | Absorbable Cranial Flap Fixation System | Chendu Medart Medical Scientific Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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? (1)
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 |
|---|---|---|---|
| * | K130309 | Rapidflap LS Cranial Flap Fixation SystemSummary page 5…ver Product Code GXR 3. Predicate Device Trade Name RapidFlap LS Cranial Fixation Flap System Submission Number K130309 Regulation Number 21 CFR § 882.5250 Device Class II Regulation Description Burr… | 2013 |
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 22 years and passes through 4 companies; a new generation was cleared every 9.2 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All GXR devicesGXR Cover, Burr Hole: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Absorbable Cranial Flap Fixation System is intended to be used for fixation of cranial bone flaps following craniotomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221606 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221606: Absorbable Cranial Flap Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221606
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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