510(k) · Cleared
ClearedBone Source Hac Rapid Setting Cement
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 Feb 9, 2005 as substantially equivalent to K032366 (Stryker Instruments, 2003) after a 68-day review. Its family tree reaches back 6 generations to 1987. 36 later devices descend from it.
- Decided
- Feb 9, 2005
- Review
- 68 days
- Class
- Class II
- Product code
- GXP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K873689 (1987). 12 ancestors in all. 36 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 5 generations backK953339 Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1996
- 4 generations backK973789 Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian…Norian Corp. · 1998
- 3 generations backK991398 Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger · 1999
- 2 generations backK021440 Bonesource HacStryker Instruments · 2002
- 1 generation backK032366 Bonesource Hac Fast Setting CementStryker Instruments · 2003
- This deviceK043334 Bone Source Hac Rapid Setting CementStryker Instruments · 2005
- Descendant · cites it directly · 30 of its ownK060061 Stryker Injectable CementStryker Corp. · 2006
- Descendant · 2 generations on · 10 of its ownK161447 HydroSet XTOrthovita, Inc. · 2016 · Recalled
- Descendant · cites it directly · 8 of its ownK060763 Stryker Injectable CementStryker · 2006 · Recalled
- Descendant · 3 generations on · 4 of its ownK173008 SCS 17-01Anika Therapeutics, Inc. · 2017
- Descendant · 3 generations on · 3 of its ownK222063 MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc. · 2023
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K060061Stryker Injectable CementStryker Corp. · 2006 · cites it directly30descendants
- K161447HydroSet XTOrthovita, Inc. · 2016 · 2 generations on10descendants
- K060763Stryker Injectable CementStryker · 2006 · cites it directly8descendants
- K173008SCS 17-01Anika Therapeutics, Inc. · 2017 · 3 generations on4descendants
- K222063MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc. · 2023 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K873689 | Cranioplastic, Acrylic Cranioplasty Material | Dentsply Intl. | 1987 | — |
| −5 | K953339 | Bonesource Hydroxyapatite Cement (Hac) | Osteogenics, Inc. | 1996 | — |
| −4 | K973789 | Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair… | Norian Corp. | 1998 | — |
| −3 | K991398 | Bonesource Hydroxyapatite Cement (Hac) Expanded Kit | Stryker Leibinger | 1999 | — |
| −2 | K021440 | Bonesource Hac | Stryker Instruments | 2002 | — |
| −1 | K032366 | Bonesource Hac Fast Setting Cement | Stryker Instruments | 2003 | — |
| 0 (this device) | K043334 | Bone Source Hac Rapid Setting Cement | Stryker Instruments | 2005 | — |
| +1 | K060061 | Stryker Injectable Cement | Stryker Corp. | 2006 | — |
| +2 | K161447 | HydroSet XT | Orthovita, Inc. | 2016 | 2 |
| +1 | K060763 | Stryker Injectable Cement | Stryker | 2006 | 1 |
| +3 | K173008 | SCS 17-01 | Anika Therapeutics, Inc. | 2017 | — |
| +3 | K222063 | MONTAGE Settable, Resorbable Bone Putty | Orthocon, Inc. | 2023 | — |
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 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 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 |
|---|---|---|---|
| * | K032366 | Bonesource Hac Fast Setting CementSummary page 1…entical to the predicate device. Substantial Equivalency Information BoneSource® HAC Rapid Setting Cement is substantially equivalent to BoneSource® HAC (K032366). $+' DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 2003 |
What descends from it? (36)
See all 365 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 18 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K060061 (Stryker Corp., 2006) has gone furthest, with 30 descendants of its own.
- 1 other device also cites its predicate K032366.
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?
BoneSource® HAC Rapid Setting Cement 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/K043334 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043334: Bone Source Hac Rapid Setting Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043334
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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