510(k) · Cleared
ClearedBond Apatite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Augma Biomaterials, Ltd. · LYC Bone Grafting Material, Synthetic
Cleared on Dec 5, 2013 as substantially equivalent to K083858 (Augma Biomaterials, Ltd., 2009) and 2 other predicates after a 596-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Dec 5, 2013
- Review
- 596 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K960978 (1996). 16 ancestors in all, the oldest K910432 (1991). No later device cites it as a predicate yet.
- Root · 7 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 6 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 5 generations backK030131 Ossatura BCP Bone Void FillerIsotis NV · 2003
- 4 generations backK033722 Apapore Bone Graft SubstituteApatech, Ltd. · 2004
- 3 generations backK051951 Cerament Bone Void FillerBonesupport AB · 2005
- 2 generations backK073316 Cerament Bone Void Filler, Model A0210Bonesupport AB · 2008
- 1 generation backK090871 Cerament Ibone Void Filler High Contrast, Model a 0210-12Bonesupport AB · 2009
- This deviceK121177 Bond ApatiteAugma Biomaterials, Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −6 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −5 | K030131 | Ossatura BCP Bone Void Filler | Isotis NV | 2003 | — |
| −4 | K033722 | Apapore Bone Graft Substitute | Apatech, Ltd. | 2004 | — |
| −3 | K051951 | Cerament Bone Void Filler | Bonesupport AB | 2005 | — |
| −2 | K073316 | Cerament Bone Void Filler, Model A0210 | Bonesupport AB | 2008 | — |
| −1 | K090871 | Cerament Ibone Void Filler High Contrast, Model a 0210-12 | Bonesupport AB | 2009 | — |
| 0 (this device) | K121177 | Bond Apatite | Augma Biomaterials, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2009 | 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? (3)
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 |
|---|---|---|---|
| * | K083858 | Bond BoneSummary page 2…v and phase Parity. The calcium sulfate material is Bond BoneTM. a mixture of surgical grade calcium sulfate dihydrate and calcium sulfate hemihydrate. and cleared under K083858. T'he calcium sulfate component conforms to the chemical requirements of ASTM F2224 Stanidaird Specificaition for-High Purity Cal… | 2009 |
| * | K090871 | Cerament Ibone Void Filler High Contrast, Model a 0210-12Summary page 2…les to the following legally marketed predicate devices: Augma Biomaterials. Ltd.. Bond BoneTM. K083858: BONESUPPORT AB, CERAMENP~MIBONE VOID FILLER (A02 10-12). K090871I; and Lifecore Biomedical. Inc.. HAPSET Hydroxylapatite Bone Graft Plaster. K910432. The intended use, materials, design, and… | 2009 |
| * | K910432 | Hapset Hydroxylapatite Bone Graft PlasterSummary page 2…ond BoneTM. K083858: BONESUPPORT AB, CERAMENP~MIBONE VOID FILLER (A02 10-12). K090871I; and Lifecore Biomedical. Inc.. HAPSET Hydroxylapatite Bone Graft Plaster. K910432. The intended use, materials, design, and functional characteristics of Bond Apatite and the predicate devices are substantially… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- None of the 16 ancestors has a recall.
- 1 other device also cites its predicate K083858.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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?
Bond Apatite is a synthetic osteoconductive, bioresorbable bone grafting material composed of hydroxyapatite and biphasic calcium sulfate in granulated powder form, intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121177 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121177: Bond Apatite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121177
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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