510(k) · Cleared
ClearedBonesource Hydroxyapatite Cement (Hac) Expanded Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Leibinger · GXP Methyl Methacrylate For Cranioplasty
Cleared on Sep 22, 1999 as substantially equivalent to K953339 (Osteogenics, Inc., 1996) and 3 other predicates after a 153-day review. Its family tree reaches back 3 generations to 1987. 45 later devices descend from it.
- Decided
- Sep 22, 1999
- Review
- 153 days
- Class
- Class II
- Product code
- GXP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K873689 (1987). 6 ancestors in all. 45 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 2 generations backK953339 Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1996
- 1 generation backK973789 Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian…Norian Corp. · 1998
- This deviceK991398 Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger · 1999
- Descendant · cites it directly · 43 of its ownK021440 Bonesource HacStryker Instruments · 2002
- Descendant · 2 generations on · 41 of its ownK032366 Bonesource Hac Fast Setting CementStryker Instruments · 2003
- Descendant · 3 generations on · 36 of its ownK043334 Bone Source Hac Rapid Setting CementStryker Instruments · 2005
- Descendant · 4 generations on · 30 of its ownK060061 Stryker Injectable CementStryker Corp. · 2006
- Descendant · 5 generations on · 10 of its ownK161447 HydroSet XTOrthovita, Inc. · 2016 · Recalled
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K021440Bonesource HacStryker Instruments · 2002 · cites it directly43descendants
- K032366Bonesource Hac Fast Setting CementStryker Instruments · 2003 · 2 generations on41descendants
- K043334Bone Source Hac Rapid Setting CementStryker Instruments · 2005 · 3 generations on36descendants
- K060061Stryker Injectable CementStryker Corp. · 2006 · 4 generations on30descendants
- K161447HydroSet XTOrthovita, Inc. · 2016 · 5 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K873689 | Cranioplastic, Acrylic Cranioplasty Material | Dentsply Intl. | 1987 | — |
| −2 | K953339 | Bonesource Hydroxyapatite Cement (Hac) | Osteogenics, Inc. | 1996 | — |
| −1 | K973789 | Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair… | Norian Corp. | 1998 | — |
| 0 (this device) | K991398 | Bonesource Hydroxyapatite Cement (Hac) Expanded Kit | Stryker Leibinger | 1999 | — |
| +1 | K021440 | Bonesource Hac | Stryker Instruments | 2002 | — |
| +2 | K032366 | Bonesource Hac Fast Setting Cement | Stryker Instruments | 2003 | — |
| +3 | K043334 | Bone Source Hac Rapid Setting Cement | Stryker Instruments | 2005 | — |
| +4 | K060061 | Stryker Injectable Cement | Stryker Corp. | 2006 | — |
| +5 | K161447 | HydroSet XT | Orthovita, Inc. | 2016 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K953339 | Bonesource Hydroxyapatite Cement (Hac) Our OCR of the scanned summary read K853339, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “BoneSource Hydroxyapatite Cement”. | 1996 |
| * | K964537 | Bonesource Hydroxyapatite Cement (Hac) Our OCR of the scanned summary read K864537, FDA’s number for 40CC Percutaneous Pre-Furl (D/L) Balloon Catheter (Aries Medical, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “BoneSource Hydroxyapatite Cement”. | 1997 |
| * | K970400 | Bone Source HydroxyapatiteSummary page 1…370 x5045 April 14, 1999 The BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit is substantially equivalent to BoneSource Hydroxyapatite Cement (K853339, K864537 and K970400) and to Norian® CRS™ Craniofacial Repair System (K973789). Device Description The BoneSource® Hydroxyapatite Cement (HAC) Expan… | 1997 |
| * | K973789 | Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair System…Summary page 1…Cement (HAC) Expanded Kit is substantially equivalent to BoneSource Hydroxyapatite Cement (K853339, K864537 and K970400) and to Norian® CRS™ Craniofacial Repair System (K973789). Device Description The BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit contains the previously- cleared BoneSource hydro… | 1998 |
What descends from it? (45)
See all 452 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 12 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K021440 (Stryker Instruments, 2002) has gone furthest, with 43 descendants of its own.
- 3 other devices also cite its predicate K953339.
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?
The BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit is indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface area no larger than 25cm’ per defect. BoneSource is also indicated for augmentation or restoration of bony contour in the craniofacial skeleton including the fronto-orbital, malar and mental areas.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991398 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991398: Bonesource Hydroxyapatite Cement (Hac) Expanded Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991398
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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