510(k) · Cleared
ClearedBSM Bone Substitute Material Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Etex Corp. · LYC Bone Grafting Material, Synthetic
Cleared on Aug 5, 1997 after a 403-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Aug 5, 1997
- Review
- 403 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK962548 BSM Bone Substitute Material KitEtex Corp. · 1997
- Descendant · cites it directly · 2 of its ownK091729 Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp. · 2009
- Descendant · cites it directly · 2 of its ownK983104 Norian Periodontal/Dental Cement (PDC)Norian Corp. · 1999
- Descendant · 2 generations on · 1 of its ownK101827 OsteoscafTexas Innovative Medical Devices (Dba) Skeletal · 2011
- Descendant · 3 generations on · 0 of its ownK213260 CMFlexTMDimension Inx Corp. · 2022
- Descendant · 2 generations on · 0 of its ownK100883 CarrigenEtex Corp. · 2010
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K091729Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp. · 2009 · cites it directly2descendants
- K983104Norian Periodontal/Dental Cement (PDC)Norian Corp. · 1999 · cites it directly2descendants
- K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal · 2011 · 2 generations on1descendant
- K213260CMFlexTMDimension Inx Corp. · 2022 · 3 generations on0descendants
- K100883CarrigenEtex Corp. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962548 | BSM Bone Substitute Material Kit | Etex Corp. | 1997 | — |
| +1 | K091729 | Alpha-BSM, Beta-BSM, Gamma-BSM, Equivabone | Etex Corp. | 2009 | — |
| +1 | K983104 | Norian Periodontal/Dental Cement (PDC) | Norian Corp. | 1999 | — |
| +2 | K101827 | Osteoscaf | Texas Innovative Medical Devices (Dba) Skeletal | 2011 | — |
| +3 | K213260 | CMFlexTM | Dimension Inx Corp. | 2022 | — |
| +2 | K100883 | Carrigen | Etex Corp. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2022 | 1 | 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 LYC? 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 LYC device
- #1 K253317 Cytrans™ Elashieldscore 14.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | OsteoGen® Named without a submission number | |
| * | — | Hapset® Named without a submission number |
What descends from it? (6)
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?
- Of its descendants, K091729 (Etex Corp., 2009) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYC
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYC
2in 2025
MAUDE reports naming product code LYC, 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 | 13 | 80 | 0 | 23 |
| 2008 | 8 | 73 | 0 | 25 |
| 2009 | 14 | 100 | 1 | 25 |
| 2010 | 13 | 164 | 2 | 28 |
| 2011 | 9 | 224 | 0 | 21 |
| 2012 | 5 | 120 | 2 | 10 |
| 2013 | 2 | — | 0 | 12 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 2 | — | 2 | 140 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 1 | 14 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 3 | 156 | 0 | 5 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 2 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 3 | 267 | 0 | 2 |
| 2026 | 3 | 266 | 0 | — |
What is it indicated for?
o-BSM™ Bane Substitute Material is a synthetic calcium phosphate hydroxylapatitic material intended to aid in the healing of periodontal bone wall defects, extraction socket defects, and for repair of cysts or other defects in the alveolar ridge or wall.
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/K962548 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962548: BSM Bone Substitute Material Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962548
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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