510(k) · Cleared
ClearedCalmatrix Calcium Sulfate Bone Graft Binder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifecore Biomedical, Inc. · LYC Bone Grafting Material, Synthetic
Cleared on Jul 19, 2004 as substantially equivalent to K955096 (Lifecore Biomedical, Inc., 1996) and 1 other predicate after a 62-day review. Its family tree reaches back 1 generation to 1996. 4 later devices descend from it.
- Decided
- Jul 19, 2004
- Review
- 62 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K955096 (1996). 2 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK955096 Capset Calcium Sulfate Bone Graft PlasterLifecore Biomedical, Inc. · 1996
- This deviceK041324 Calmatrix Calcium Sulfate Bone Graft BinderLifecore Biomedical, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK060285 Bonegen - TRBio-Lok Intl., Inc. · 2006
- Descendant · cites it directly · 0 of its ownK131385 Easy-GraftDegradable Solutions AG · 2013
- Descendant · cites it directly · 0 of its ownK113049 Socket GraftSteiner Laboratories · 2012
- Descendant · 2 generations on · 0 of its ownK102208 NanogenOrthogen, LLC · 2011
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955096 | Capset Calcium Sulfate Bone Graft Plaster | Lifecore Biomedical, Inc. | 1996 | — |
| 0 (this device) | K041324 | Calmatrix Calcium Sulfate Bone Graft Binder | Lifecore Biomedical, Inc. | 2004 | — |
| +1 | K060285 | Bonegen - TR | Bio-Lok Intl., Inc. | 2006 | — |
| +1 | K131385 | Easy-Graft | Degradable Solutions AG | 2013 | — |
| +1 | K113049 | Socket Graft | Steiner Laboratories | 2012 | — |
| +2 | K102208 | Nanogen | Orthogen, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K955096 | Capset Calcium Sulfate Bone Graft PlasterSummary page 1…Plaster of Paris has been determined. Reference FDA Publication 91-4246. Identification of CAPSET Calcium Sulfate Bone Graft Barrier (K955096) Equivalent Devices ALLOMATRIX® Putty (K020895) 3. Device Description Lifecore Biomedical CalMatrix Calcium Sulfate Bone G… | 1996 |
| * | K020895 | Allomatrix Model# 86Summary page 1…en determined. Reference FDA Publication 91-4246. Identification of CAPSET Calcium Sulfate Bone Graft Barrier (K955096) Equivalent Devices ALLOMATRIX® Putty (K020895) 3. Device Description Lifecore Biomedical CalMatrix Calcium Sulfate Bone Graft Binder (CalMatrix) is a calcium sulfate materia… | 2004 |
What descends from it? (4)
3 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?
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
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…
Read the full statement (168 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041324 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041324: Calmatrix Calcium Sulfate Bone Graft Binder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041324
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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