510(k) · Cleared
ClearedHapset Hydroxylapatite Bone Graft Plaster
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifecore Biomedical, Inc. · LZK Implant, Malar
Cleared on Jun 28, 1996 as substantially equivalent to K910432 (Lifecore Biomedical, Inc., 1991) after a 70-day review. Its family tree reaches back 1 generation to 1991. 11 later devices descend from it.
- Decided
- Jun 28, 1996
- Review
- 70 days
- Class
- Class II
- Product code
- LZK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910432 (1991). 11 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK910432 Hapset Hydroxylapatite Bone Graft PlasterLifecore Biomedical, Inc. · 1991
- This deviceK961511 Hapset Hydroxylapatite Bone Graft PlasterLifecore Biomedical, Inc. · 1996
- Descendant · cites it directly · 10 of its ownK051951 Cerament Bone Void FillerBonesupport AB · 2005
- Descendant · 2 generations on · 6 of its ownK073316 Cerament Bone Void Filler, Model A0210Bonesupport AB · 2008
- Descendant · 3 generations on · 3 of its ownK201535 Cerament Bone Void FillerBonesupport AB · 2020
- Descendant · 4 generations on · 2 of its ownK212083 Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc. · 2021
- Descendant · 2 generations on · 2 of its ownK071004 Osteocrete Bone Void FillerBone Solutions, Inc. · 2009
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K051951Cerament Bone Void FillerBonesupport AB · 2005 · cites it directly10descendants
- K073316Cerament Bone Void Filler, Model A0210Bonesupport AB · 2008 · 2 generations on6descendants
- K201535Cerament Bone Void FillerBonesupport AB · 2020 · 3 generations on3descendants
- K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc. · 2021 · 4 generations on2descendants
- K071004Osteocrete Bone Void FillerBone Solutions, Inc. · 2009 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910432 | Hapset Hydroxylapatite Bone Graft Plaster | Lifecore Biomedical, Inc. | 1991 | — |
| 0 (this device) | K961511 | Hapset Hydroxylapatite Bone Graft Plaster | Lifecore Biomedical, Inc. | 1996 | — |
| +1 | K051951 | Cerament Bone Void Filler | Bonesupport AB | 2005 | — |
| +2 | K073316 | Cerament Bone Void Filler, Model A0210 | Bonesupport AB | 2008 | — |
| +3 | K201535 | Cerament Bone Void Filler | Bonesupport AB | 2020 | — |
| +4 | K212083 | Tactoset Injectable Bone Substitute | Anika Therapeutics, Inc. | 2021 | — |
| +2 | K071004 | Osteocrete Bone Void Filler | Bone Solutions, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 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 LZK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (13)
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 |
|---|---|---|---|
| * | K910432 | Hapset Hydroxylapatite Bone Graft Plaster Our OCR of the scanned summary read “K910432.” beside “510(k)”; FDA’s K910432 is the only number that fits it and carries the summary’s name for the device. Summary page 3…e o THU T2l LIFECORE 5 QM- 54, L W AT Rt P, N4 ~ Kag(s( 343 Further, HAPSET has beccn commercially distributed by Lifecore since 1991, cleared for marketlng by 510(k) K910432. No side effects, adverse events or toxic symptoms have been reported to date accordlng to Lifecore and MDR databases. The HA-500… | 1991 |
| * | — | Prosthesis, chin, Internal — Interpore Named without a submission number | |
| * | — | Prosthesis, chin, Internal — Vitek Named without a submission number | |
| * | — | Mesh, Surgical, Polymeric — Davol Named without a submission number | |
| * | — | Mesh, Surgical, Polymeric — Ethicon Named without a submission number | |
| * | — | Mesh, Surgical, Polymeric — Gambro Named without a submission number | |
| * | — | Mesh, Surgical, Polymeric — W.L. Gore and Associates Named without a submission number | |
| * | — | Prosthesis, PTFE/Carbon Fiber — Vitek Named without a submission number | |
| * | — | Polytetrafluoroethylene Vitreous Carbon Materials for Maxillofacial Reconstruction —… Named without a submission number | |
| * | — | Polytetrafluoroethylene Vitreous Carbon Materials for Maxillofacial Reconstruction —… Named without a submission number | |
| * | — | Demineralized Bone Graft products — Crafton Named without a submission number | |
| * | — | Demineralized Bone Graft products — Tissue Bank sources Named without a submission number | |
| * | — | Hydroxylapatite blocks Named without a submission number |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051951 | Cerament Bone Void Filler | 2005 | 10 |
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?
How does its category compare?
All LZK devicesLZK Implant, Malar: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZK
FDA has decided no LZK device since 2007.
Median 510(k) review, days · LZK
Too few LZK 510(k)s in any year since 2007 to give a median.
Recalls per year · LZK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZK
1in 2022
MAUDE reports naming product code LZK, 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 | 0 | — | 3 | 10 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
HAPSET is intended for use in facial reconstructive surgery as a paste implant that will set up into a solid block implant of hydroxylapatite and medical grade calcium sulfate. This hydroxylapatite block serves to correct contour defects of facial structures such as chin, mandible, malar region, and maxilla.
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/K961511 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961511: 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/K961511
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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