510(k) · Cleared
ClearedAlpha-BSM, Beta-BSM, Gamma-BSM, Equivabone
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 Dec 23, 2009 as substantially equivalent to K962548 (Etex Corp., 1997) and 7 other predicates after a 195-day review. Its family tree reaches back 6 generations to 1997. 2 later devices descend from it.
- Decided
- Dec 23, 2009
- Review
- 195 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 6 generations to K963562 (1997). 23 ancestors in all, the oldest K873689 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK963562 Wright Plaster of Paris PelletsWrightmedicaltechnologyinc · 1997
- 5 generations backK020078 Exactech Resorbable Bone PasteExactech, Inc. · 2004
- 4 generations backK053098 Optium DBM Gel and PuttyLifenet · 2005
- 3 generations backK063050 Cap PlusEtex Corp. · 2007
- 2 generations backK080329 Cap Plus, Equivabone, Cap/DBMEtex Corp. · 2008
- 1 generation backK090310 EquivaboneEtex Corp. · 2009
- This deviceK091729 Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp. · 2009
- Descendant · cites it directly · 0 of its ownK100883 CarrigenEtex Corp. · 2010
- Descendant · cites it directly · 0 of its ownK102812 Gamma-BSM; Beta-BSM; EquivaboneEtex Corporation · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K963562 | Wright Plaster of Paris Pellets | Wrightmedicaltechnologyinc | 1997 | — |
| −5 | K020078 | Exactech Resorbable Bone Paste | Exactech, Inc. | 2004 | — |
| −4 | K053098 | Optium DBM Gel and Putty | Lifenet | 2005 | — |
| −3 | K063050 | Cap Plus | Etex Corp. | 2007 | — |
| −2 | K080329 | Cap Plus, Equivabone, Cap/DBM | Etex Corp. | 2008 | — |
| −1 | K090310 | Equivabone | Etex Corp. | 2009 | — |
| 0 (this device) | K091729 | Alpha-BSM, Beta-BSM, Gamma-BSM, Equivabone | Etex Corp. | 2009 | — |
| +1 | K100883 | Carrigen | Etex Corp. | 2010 | — |
| +1 | K102812 | Gamma-BSM; Beta-BSM; Equivabone | Etex Corporation | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (9)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K962548 | BSM Bone Substitute Material KitSummary page 1…rietary Name: Alpha-bsm Bone Substitute Material Predicate Device(s): ct-BSM Bone Substitute Material (ETEX Corporation, K962548 LYC Dental indication) a-BSM Bone Substitute Material (ETEX Corporation,… | 1997 |
| Kept off the family tree | K980223 | a-BSM Bone Substitute Material Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…K962548 LYC Dental indication) a-BSM Bone Substitute Material (ETEX Corporation, K980223 LZK Maxillofacial indication) ac-BSM Bone Substitute Material (ETEX Corporation,… | |
| * | K983009 | BSM- Bone Substitute MaterialSummary page 1…K980223 LZK Maxillofacial indication) ac-BSM Bone Substitute Material (ETEX Corporation, K983009 GXP Cranioplasty indication) a-BSM Bone Substitute Material (ETEX Corporation,… | 1998 |
| * | K032307 | Cap Bone Substitute MaterialSummary page 1…K983009 GXP Cranioplasty indication) a-BSM Bone Substitute Material (ETEX Corporation, K032307 GXP Cranioplasty indication) a-BSM Bone Substitute Material (ETEX Corporation,… | 2003 |
| * | K072636 | A-BSM Bone Substitute MaterialSummary page 1…K032307 GXP Cranioplasty indication) a-BSM Bone Substitute Material (ETEX Corporation, K072636 MQV Extremities, Pelvis and Spine indication) GRAFTON® DBM (Osteotech, KO0i1188, NUN)… | 2007 |
| * | K051188 | Grafton DBMSummary page 3…Beta-bsm Injectable Bone Substitute Material (ETEX Corporation, K090242) GRAFTON® DBM (Osteotech, KO051188, NUN) Device Description: Beta-bsm Injectable Bone Substitute Material is a syntheti… | 2006 |
| * | K090242 | Gamma-BSM, Beta-BSMSummary page 3…tremities, Pelvis and Spine indication) Beta-bsm Injectable Bone Substitute Material (ETEX Corporation, K090242) GRAFTON® DBM (Osteotech, KO051188, NUN) Device Description: Beta-bsm Injectable Bo… | 2009 |
| * | K080329 | Cap Plus, Equivabone, Cap/DBMSummary page 7…mities, Pelvis and Spine indication) EquivaBone Osteoinductive Bone Graft Substitute (ETEX Corporation, K080329 and K0903 10) GRAFTON® DBM (Osteotech, KO051188, NUN) Device Description: EquivaBon… | 2008 |
| * | K090310 | EquivaboneSummary page 7…is and Spine indication) EquivaBone Osteoinductive Bone Graft Substitute (ETEX Corporation, K080329 and K0903 10) GRAFTON® DBM (Osteotech, KO051188, NUN) Device Description: EquivaBone is a biocom… | 2009 |
What descends from it? (2)
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 12 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 23 ancestors have a recall of any class.
- Of its descendants, K100883 (Etex Corp., 2010) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K962548.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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?
EquivaBone Osteoinductive Bone Graft Substitute is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix combined with demnineralized bone matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects that are not intrinsic to the stability of the bony structure. These defects may be surgically created…
Read the full statement (519 words)
EquivaBone Osteoinductive Bone Graft Substitute is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix combined with demnineralized bone matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
EquivaBone Osteoinductive Bone Graft Substitute is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Alpha-bsm Bone Substitute Material is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Alpha-bsm Bone Substitute Material is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontallinfrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Gammna-bism Moldable Bone Substitute Material is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Gamma-bsmi Moldable Bone Substitute Material is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects; alveolar ridge augmentation (osteotomny, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Beta-bsm Injectable Bone Substitute Material is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Beta-bsm Injectable Bone Substitute Material is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects; alveolar ridge augmentation. (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091729 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091729: Alpha-BSM, Beta-BSM, Gamma-BSM, Equivabone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091729
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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