510(k) · Cleared
ClearedBSM- Bone Substitute Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Etex Corp. · GXP Methyl Methacrylate For Cranioplasty
Cleared on Nov 25, 1998 as substantially equivalent to K953339 (Osteogenics, Inc., 1996) after an 89-day review. Its family tree reaches back 2 generations to 1987. 4 later devices descend from it.
- Decided
- Nov 25, 1998
- Review
- 89 days
- Class
- Class II
- Product code
- GXP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K873689 (1987). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 1 generation backK953339 Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1996
- This deviceK983009 BSM- Bone Substitute MaterialEtex Corp. · 1998
- Descendant · cites it directly · 3 of its ownK032307 Cap Bone Substitute MaterialEtex Corp. · 2003
- Descendant · cites it directly · 2 of its ownK091729 Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp. · 2009
- Descendant · 2 generations on · 0 of its ownK100883 CarrigenEtex Corp. · 2010
- Descendant · 2 generations on · 0 of its ownK102812 Gamma-BSM; Beta-BSM; EquivaboneEtex Corporation · 2010
Most influential descendants
Showing 4 of 4 · See all- K032307Cap Bone Substitute MaterialEtex Corp. · 2003 · cites it directly3descendants
- K091729Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp. · 2009 · cites it directly2descendants
- K100883CarrigenEtex Corp. · 2010 · 2 generations on0descendants
- K102812Gamma-BSM; Beta-BSM; EquivaboneEtex Corporation · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K873689 | Cranioplastic, Acrylic Cranioplasty Material | Dentsply Intl. | 1987 | — |
| −1 | K953339 | Bonesource Hydroxyapatite Cement (Hac) | Osteogenics, Inc. | 1996 | — |
| 0 (this device) | K983009 | BSM- Bone Substitute Material | Etex Corp. | 1998 | — |
| +1 | K032307 | Cap Bone Substitute Material | Etex Corp. | 2003 | — |
| +1 | K091729 | Alpha-BSM, Beta-BSM, Gamma-BSM, Equivabone | Etex Corp. | 2009 | — |
| +2 | K100883 | Carrigen | Etex Corp. | 2010 | — |
| +2 | K102812 | Gamma-BSM; Beta-BSM; Equivabone | Etex Corporation | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 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 |
|---|---|---|---|
| * | K953339 | Bonesource Hydroxyapatite Cement (Hac)Summary page 1…titute Matenal 2.3 Classification Name and Code: Methyl Methacrylate for Cranioplasty, Code GXP 2.4 Predicate Device: BoneSource™ Hydroxyapatite Cement S10(k) No.: K953339, Osteogenics, Inc. 2.5 Description of Device ETEX a-BSM™ Bone Substitute Material for Cranioplasty is a self-setting, syntheti… | 1996 |
What descends from it? (4)
2 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 11 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K032307 (Etex Corp., 2003) has gone furthest, with 3 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?
a-BSM™ Bone Substitute Material is a synthetic calcium phosphate hydroxyapatitic material intended to be implanted for use in the filling, repair, reconstruction and augmentation of burr holes, contiguous craniotomy cuts, and other defects in craniofacial bones including fronto-orbital, malar and mental areas with a surface area no larger than 25cm².
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/K983009 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983009: BSM- Bone Substitute Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983009
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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