510(k) · Cleared
ClearedCranioplug
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ossdsign AB · GXR Cover, Burr Hole
Cleared on Oct 3, 2014 as substantially equivalent to K120352 (Stryker, 2012) and 1 other predicate after a 238-day review. Its family tree reaches back 8 generations to 1987. 2 later devices descend from it.
- Decided
- Oct 3, 2014
- Review
- 238 days
- Class
- Class II
- Product code
- GXR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K873689 (1987). 49 ancestors in all, the oldest K761228 (1976). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 7 generations backK953339 Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1996
- 6 generations backK973789 Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian…Norian Corp. · 1998
- 5 generations backK991398 Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger · 1999
- 4 generations backK021440 Bonesource HacStryker Instruments · 2002
- 3 generations backK032366 Bonesource Hac Fast Setting CementStryker Instruments · 2003
- 2 generations backK043334 Bone Source Hac Rapid Setting CementStryker Instruments · 2005
- 1 generation backK051603 Stryker Injectable CementStryker Leibinger Micro Implants · 2005
- This deviceK140309 CranioplugOssdsign AB · 2014
- Descendant · cites it directly · 1 of its ownK181539 OSSDSIGN CranioplugOssdsign AB · 2018
- Descendant · 2 generations on · 0 of its ownK253447 Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K873689 | Cranioplastic, Acrylic Cranioplasty Material | Dentsply Intl. | 1987 | — |
| −7 | K953339 | Bonesource Hydroxyapatite Cement (Hac) | Osteogenics, Inc. | 1996 | — |
| −6 | K973789 | Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair… | Norian Corp. | 1998 | — |
| −5 | K991398 | Bonesource Hydroxyapatite Cement (Hac) Expanded Kit | Stryker Leibinger | 1999 | — |
| −4 | K021440 | Bonesource Hac | Stryker Instruments | 2002 | — |
| −3 | K032366 | Bonesource Hac Fast Setting Cement | Stryker Instruments | 2003 | — |
| −2 | K043334 | Bone Source Hac Rapid Setting Cement | Stryker Instruments | 2005 | — |
| −1 | K051603 | Stryker Injectable Cement | Stryker Leibinger Micro Implants | 2005 | — |
| 0 (this device) | K140309 | Cranioplug | Ossdsign AB | 2014 | — |
| +1 | K181539 | OSSDSIGN Cranioplug | Ossdsign AB | 2018 | — |
| +2 | K253447 | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) | Orthocon, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1986 | 3 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 6 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K120352 | Stryker Quikflap Sterile Procedure PackSummary page 4…over 6. Classification Name: Cover, Burr Hole (21 CFR 882.5250, Product Code GXR) 7. Class: 2 8. Predicates: K120352 Stryker QuikFlap Sterile Procedure Pack (Burr Hole Cover, 14 mm) K051603 Stryker Injectable Cement… | 2012 |
| * | K051603 | Stryker Injectable CementSummary page 4…) 7. Class: 2 8. Predicates: K120352 Stryker QuikFlap Sterile Procedure Pack (Burr Hole Cover, 14 mm) K051603 Stryker Injectable Cement 9. Device Description: Cranioplug consists of a titanium (Ti) mesh plate with a biocompati… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181539 | OSSDSIGN Cranioplug | 2018 | 1 |
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 27 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 49 ancestors have a recall of any class.
- Of its descendants, K181539 (Ossdsign AB, 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K120352.
How does its category compare?
All GXR devicesGXR Cover, Burr Hole: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
OssDsign Cranioplug is intended to cover and plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery. It is cleared for use for non-weight bearing applications in adults and adolescents age 12 and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140309: Cranioplug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140309
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