# K961511: Hapset Hydroxylapatite Bone Graft Plaster

- Pathway: 510(k) (Traditional)
- Applicant: Lifecore Biomedical, Inc.
- Decided: Jun 28, 1996 after 70 days
- Product code: LZK (Implant, Malar)
- Device class: 2
- Regulation: 21 CFR 878.3550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910432 (1991). 1 ancestor in all.
11 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910432: Hapset Hydroxylapatite Bone Graft Plaster, Lifecore Biomedical, Inc. (1991). 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.
- (no number) Prosthesis, chin, Internal — Interpore: named in the summary without a submission number
- (no number) Prosthesis, chin, Internal — Vitek: named in the summary without a submission number
- (no number) Mesh, Surgical, Polymeric — Davol: named in the summary without a submission number
- (no number) Mesh, Surgical, Polymeric — Ethicon: named in the summary without a submission number
- (no number) Mesh, Surgical, Polymeric — Gambro: named in the summary without a submission number
- (no number) Mesh, Surgical, Polymeric — W.L. Gore and Associates: named in the summary without a submission number
- (no number) Prosthesis, PTFE/Carbon Fiber — Vitek: named in the summary without a submission number
- (no number) Polytetrafluoroethylene Vitreous Carbon Materials for Maxillofacial Reconstruction — Biomet: named in the summary without a submission number
- (no number) Polytetrafluoroethylene Vitreous Carbon Materials for Maxillofacial Reconstruction — Kimberly-Clark: named in the summary without a submission number
- (no number) Demineralized Bone Graft products — Crafton: named in the summary without a submission number
- (no number) Demineralized Bone Graft products — Tissue Bank sources: named in the summary without a submission number
- (no number) Hydroxylapatite blocks: named in the summary without a submission number

## Most influential descendants
- K051951: Cerament Bone Void Filler (2005), 10 descendants of its own
- K073316: Cerament Bone Void Filler, Model A0210 (2008), 6 descendants of its own
- K201535: Cerament Bone Void Filler (2020), 3 descendants of its own
- K212083: Tactoset Injectable Bone Substitute (2021), 2 descendants of its own
- K071004: Osteocrete Bone Void Filler (2009), 2 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K961511
Methodology: https://510kreport.com/methodology