510(k) · Cleared

Cleared

Hapset Hydroxylapatite Bone Graft Plaster

K910432510(k) TraditionalCleared May 1, 199190-day reviewClass II21 CFR 872.3930

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Lifecore Biomedical, Inc. · LYC Bone Grafting Material, Synthetic

Cleared on May 1, 1991 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 46 later devices descend from it.

Decided: May 1, 1991
Review: 90 days
Class: Class II
Product code: LYC
Recalls: None
Predicates: 0

46 later devices descend from it, 5 citing it directly.

This deviceK910432 Hapset Hydroxylapatite Bone Graft PlasterLifecore Biomedical, Inc. · 1991
Descendant · cites it directly · 16 of its ownK073070 Dio Biotite-H Implant SystemDio Department Dsi, Inc. · 2008
Descendant · cites it directly · 15 of its ownK030682 Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3Bioform, Inc. · 2003
Descendant · cites it directly · 11 of its ownK961511 Hapset Hydroxylapatite Bone Graft PlasterLifecore Biomedical, Inc. · 1996
Descendant · 2 generations on · 10 of its ownK112532 ET II Bio-SA Fixture SystemHiossen, Inc. · 2012
Descendant · 2 generations on · 10 of its ownK051951 Cerament Bone Void FillerBonesupport AB · 2005

Showing 5 of 46 descendants. See all descendants

Descendants cleared per year

1996high 5 (2008) · low 0 (1997)2026

Most influential descendants

Showing 5 of 46 · See all

K073070Dio Biotite-H Implant SystemDio Department Dsi, Inc. · 2008 · cites it directly16descendants
K030682Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3Bioform, Inc. · 2003 · cites it directly15descendants
K961511Hapset Hydroxylapatite Bone Graft PlasterLifecore Biomedical, Inc. · 1996 · cites it directly11descendants
K112532ET II Bio-SA Fixture SystemHiossen, Inc. · 2012 · 2 generations on10descendants
K051951Cerament Bone Void FillerBonesupport AB · 2005 · 2 generations on10descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K910432	Hapset Hydroxylapatite Bone Graft Plaster	Lifecore Biomedical, Inc.	1991	—
+1	K073070	Dio Biotite-H Implant System	Dio Department Dsi, Inc.	2008	—
+1	K030682	Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3	Bioform, Inc.	2003	—
+1	K961511	Hapset Hydroxylapatite Bone Graft Plaster	Lifecore Biomedical, Inc.	1996	—
+2	K112532	ET II Bio-SA Fixture System	Hiossen, Inc.	2012	—
+2	K051951	Cerament Bone Void Filler	Bonesupport AB	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2003	2	0
2005	3	0
2006	1	0
2007	1	0
2008	5	0
2009	5	0
2010	1	0
2012	2	0
2013	2	0
2014	2	0
2016	1	0
2017	1	0
2018	2	0
2019	2	0
2020	1	0
2021	1	0
2022	3	0
2023	3	0
2024	4	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K910432, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (46)

See all 46

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K073070	Dio Biotite-H Implant System	Dio Department Dsi, Inc.	2008	16
K030682	Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3	Bioform, Inc.	2003	15
K961511	Hapset Hydroxylapatite Bone Graft Plaster	Lifecore Biomedical, Inc.	1996	11
K121177	Bond Apatite	Augma Biomaterials, Ltd.	2013	0
K050170	Fortoss Vital Bone Graft Substitute	Biocomposites, Ltd.	2005	0

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, K073070 (Dio Department Dsi, Inc., 2008) has gone furthest, with 16 descendants of its own.

How does its category compare?

All LYC devices

LYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LYC

3in 2025

2007high 14 (2009) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYC

267in 2025

2007high 267 (2025) · low 73 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LYC

1in 2018

2007high 2 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LYC

2in 2025

2007high 140 (2016) · low 2 (2025)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	—

https://510kreport.com/device/K910432 · printed Nov 6, 2026

Cite this page

510(k) Report. “K910432: Hapset Hydroxylapatite Bone Graft Plaster.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910432

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026