510(k) · Cleared
ClearedBonesource Hac
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · GXP Methyl Methacrylate For Cranioplasty
Cleared on Aug 2, 2002 as substantially equivalent to K991398 (Stryker Leibinger, 1999) and 5 other predicates after an 88-day review. Its family tree reaches back 4 generations to 1987. 43 later devices descend from it.
- Decided
- Aug 2, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- GXP
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K873689 (1987). 9 ancestors in all. 43 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 3 generations backK953339 Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1996
- 2 generations backK973789 Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian…Norian Corp. · 1998
- 1 generation backK991398 Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger · 1999
- This deviceK021440 Bonesource HacStryker Instruments · 2002
- Descendant · cites it directly · 41 of its ownK032366 Bonesource Hac Fast Setting CementStryker Instruments · 2003
- Descendant · 2 generations on · 36 of its ownK043334 Bone Source Hac Rapid Setting CementStryker Instruments · 2005
- Descendant · 3 generations on · 30 of its ownK060061 Stryker Injectable CementStryker Corp. · 2006
- Descendant · 4 generations on · 10 of its ownK161447 HydroSet XTOrthovita, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 8 of its ownK060763 Stryker Injectable CementStryker · 2006 · Recalled
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K032366Bonesource Hac Fast Setting CementStryker Instruments · 2003 · cites it directly41descendants
- K043334Bone Source Hac Rapid Setting CementStryker Instruments · 2005 · 2 generations on36descendants
- K060061Stryker Injectable CementStryker Corp. · 2006 · 3 generations on30descendants
- K161447HydroSet XTOrthovita, Inc. · 2016 · 4 generations on10descendants
- K060763Stryker Injectable CementStryker · 2006 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K873689 | Cranioplastic, Acrylic Cranioplasty Material | Dentsply Intl. | 1987 | — |
| −3 | K953339 | Bonesource Hydroxyapatite Cement (Hac) | Osteogenics, Inc. | 1996 | — |
| −2 | K973789 | Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair… | Norian Corp. | 1998 | — |
| −1 | K991398 | Bonesource Hydroxyapatite Cement (Hac) Expanded Kit | Stryker Leibinger | 1999 | — |
| 0 (this device) | K021440 | Bonesource Hac | Stryker Instruments | 2002 | — |
| +1 | K032366 | Bonesource Hac Fast Setting Cement | Stryker Instruments | 2003 | — |
| +2 | K043334 | Bone Source Hac Rapid Setting Cement | Stryker Instruments | 2005 | — |
| +3 | K060061 | Stryker Injectable Cement | Stryker Corp. | 2006 | — |
| +4 | K161447 | HydroSet XT | Orthovita, Inc. | 2016 | 2 |
| +3 | K060763 | Stryker Injectable Cement | Stryker | 2006 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 7 | 0 |
| 2024 | 5 | 0 |
| 2026 | 4 | 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 GXP? 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 GXP device
- #1 K241027 Permatage Settable Bone Puttyscore 16.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K991398 | Bonesource Hydroxyapatite Cement (Hac) Expanded KitSummary page 2…1 Predicate Device BoneSourceB HAC is substantially equivalent to Bonesource@ Hydroxyapatite Cement Expanded Kit (K991398), BoneSourceB Hydroxyapatite Cement (K953339, K964537, and K970400), Biomet Inc.’s Craniofacial Calcium Phosphate Ceramic Bone Fi… | 1999 |
| * | K953339 | Bonesource Hydroxyapatite Cement (Hac)Summary page 2…Page 2 === Predicate Device BoneSourceB HAC is substantially equivalent to Bonesource@ Hydroxyapatite Cement Expanded Kit (K991398), BoneSourceB Hydroxyapatite Cement (K953339, K964537, and K970400), Biomet Inc.’s Craniofacial Calcium Phosphate Ceramic Bone Filler (K990290) and Injectable MimixTM(KO12569… | 1996 |
| * | K964537 | Bonesource Hydroxyapatite Cement (Hac)Summary page 2…== Predicate Device BoneSourceB HAC is substantially equivalent to Bonesource@ Hydroxyapatite Cement Expanded Kit (K991398), BoneSourceB Hydroxyapatite Cement (K953339, K964537, and K970400), Biomet Inc.’s Craniofacial Calcium Phosphate Ceramic Bone Filler (K990290) and Injectable MimixTM(KO12569). Devic… | 1997 |
| * | K970400 | Bone Source HydroxyapatiteSummary page 2…Device BoneSourceB HAC is substantially equivalent to Bonesource@ Hydroxyapatite Cement Expanded Kit (K991398), BoneSourceB Hydroxyapatite Cement (K953339, K964537, and K970400), Biomet Inc.’s Craniofacial Calcium Phosphate Ceramic Bone Filler (K990290) and Injectable MimixTM(KO12569). Device Description… | 1997 |
| * | K990290 | Craniofacial Calcium Phosphate Ceramic Bone FillerSummary page 2…atite Cement Expanded Kit (K991398), BoneSourceB Hydroxyapatite Cement (K953339, K964537, and K970400), Biomet Inc.’s Craniofacial Calcium Phosphate Ceramic Bone Filler (K990290) and Injectable MimixTM(KO12569). Device Description The packaging contains the following: Bonesource@ powder in a plastic bowl… | 1999 |
| * | K012569 | Modification to: Injectable Mimix | 2001 |
What descends from it? (43)
See all 433 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?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K032366 (Stryker Instruments, 2003) has gone furthest, with 41 descendants of its own.
- 1 other device also cites its predicate K991398.
How does its category compare?
All GXP devicesGXP Methyl Methacrylate For Cranioplasty: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GXP
4so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · GXP
87in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXP
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXP
1in 2025
MAUDE reports naming product code GXP, 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 | 3 | 87 | 0 | 8 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 1 | — | 1 | 22 |
| 2010 | 1 | — | 0 | 59 |
| 2011 | 0 | — | 1 | 31 |
| 2012 | 0 | — | 1 | 28 |
| 2013 | 0 | — | 0 | 18 |
| 2014 | 0 | — | 0 | 19 |
| 2015 | 1 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 17 |
| 2017 | 1 | — | 0 | 16 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 1 | — | 2 | 9 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 2 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 4 | 85 | 0 | — |
What is it indicated for?
BoneSourceO is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021440 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021440: Bonesource Hac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021440
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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