# K041324: Calmatrix Calcium Sulfate Bone Graft Binder

- Pathway: 510(k) (Traditional)
- Applicant: Lifecore Biomedical, Inc.
- Decided: Jul 19, 2004 after 62 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- Device class: 2
- Regulation: 21 CFR 872.3930
- 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 K955096 (1996). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955096: Capset Calcium Sulfate Bone Graft Plaster, Lifecore Biomedical, Inc. (1996) Summary page 1.
- K020895: Allomatrix Model# 86, Wrightmedicaltechnologyinc (2004) Summary page 1.

## Most influential descendants
- K060285: Bonegen - TR (2006), 1 descendant of its own
- K131385: Easy-Graft (2013), 0 descendants of its own
- K113049: Socket Graft (2012), 0 descendants of its own
- K102208: Nanogen (2011), 0 descendants of its own

## Indications for use
CalMatrix Calcium Sulfate Bone Graft Binder, when mixed with allograft or other bone graft material, may be used to treat multiple types of maxillary and mandibular osseous and periodontal defects such as: * Intrabony/infrabony defects · Furcation defects * Recession defects * Dehiscence/fenestration defects (natural teeth and prosthetic root form implants) · Extraction socket (ridge preservation) defects • Ridge augmentation defects · Sinus lift defects * Endodontic bony defects After site preparation in the usual manner, select an appropriately sized package of CalMatrix Binder to go with the quantity of bone graft material of choice selected to treat the defect size. Combine the two dry ingredients, add the syringe liquid provided in the CalMatrix package and mix. Place the composite graft into the prepared defect site and suture the soft tissue flaps back in the usual manner or as dictated by clinical expertise. The graft material may be covered by a barrier or membrane prior to suture placement if, in the judgment of the clinician, it is indicated.

Source page: https://510kreport.com/device/K041324
Methodology: https://510kreport.com/methodology