510(k) · Cleared
ClearedBonesource Hydroxyapatite Cement (Hac)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteogenics, Inc. · GXP Methyl Methacrylate For Cranioplasty
Cleared on Jan 24, 1997 as substantially equivalent to K873689 (Dentsply Intl., 1987) after a 73-day review. Its family tree reaches back 1 generation to 1987. 50 later devices descend from it.
- Decided
- Jan 24, 1997
- Review
- 73 days
- Class
- Class II
- Product code
- GXP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K873689 (1987). 50 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- This deviceK964537 Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1997
- Descendant · cites it directly · 49 of its ownK973789 Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian…Norian Corp. · 1998
- Descendant · cites it directly · 45 of its ownK991398 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
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K973789Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair System…Norian Corp. · 1998 · cites it directly49descendants
- K991398Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger · 1999 · cites it directly45descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K873689 | Cranioplastic, Acrylic Cranioplasty Material | Dentsply Intl. | 1987 | — |
| 0 (this device) | K964537 | Bonesource Hydroxyapatite Cement (Hac) | Osteogenics, Inc. | 1997 | — |
| +1 | 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 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | K873689 | Cranioplastic, Acrylic Cranioplasty MaterialSummary page 1…tured by L.D. Caulk Company of Milford, Delaware and distributed by Codman and Shurtleff, Inc. of Randolph, Massachusetts. CranioPlastic™ was cleared by FDA under 510(k) K873689 on October 26, 1987. 110 DEVICE DESCRIPTION The Osteogenics BoneSource® Hydroxyapatite Cement (HAC) is a self-setting, calcium p… | 1987 |
What descends from it? (50)
See all 503 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?
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 Osteogenics BoneSource® Hydroxyapatite Cement (HAC) is a self-setting, calcium phosphate cement intended 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.
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/K964537 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964537: Bonesource Hydroxyapatite Cement (Hac).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964537
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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