510(k) · Cleared
Recalled · Class II · 2015Actifuse Bone Graft Substitute, Actifuse Microgranules Bone Graft Substitute
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apatech, Ltd. · LYC Bone Grafting Material, Synthetic
Cleared on Jul 30, 2009 as substantially equivalent to K040082 (Apatech, Ltd., 2004) and 9 other predicates after a 122-day review. Its family tree reaches back 6 generations to 1999. It has been recalled once.
- Decided
- Jul 30, 2009
- Review
- 122 days
- Class
- Class II
- Product code
- LYC
- Recalls
- 1
- Predicates
- 10
Its longest line of descent runs back 6 generations to K990131 (1999). 22 ancestors in all, the oldest K860983 (1986). No later device cites it as a predicate yet.
- Root · 6 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 5 generations backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
- 4 generations backK032268 MBCPBiomatlante · 2003
- 3 generations backK043005 Modification to MBCPBiomatlante · 2005
- 2 generations backK051885 MBCPBiomatlante · 2005
- 1 generation backK060732 MBCP GelBiomatlante · 2006
- This deviceK090850 Actifuse Bone Graft Substitute, Actifuse Microgranules Bone Graft…Apatech, Ltd. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute | Interpore Cross Intl. | 1999 | — |
| −5 | K020986 | Mastergraft Resorbable Ceramic | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −4 | K032268 | MBCP | Biomatlante | 2003 | — |
| −3 | K043005 | Modification to MBCP | Biomatlante | 2005 | — |
| −2 | K051885 | MBCP | Biomatlante | 2005 | — |
| −1 | K060732 | MBCP Gel | Biomatlante | 2006 | — |
| 0 (this device) | K090850 | Actifuse Bone Graft Substitute, Actifuse Microgranules Bone Graft Substitute | Apatech, Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 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? (10)
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 |
|---|---|---|---|
| * | K040082 | Pore-SI Bone Graft SubstituteSummary page 1…ActifuseTM Flow Bone Graft Substitute Common Name: Bone Graft Substitute Predicate Devices: Actifuse T M family of bone graft substitutes, K040082, K071206, K080736, K082073, K081979, K082575 Biomatlante MBCP, K060732, K051885… | 2004 |
| * | K071206 | Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteSummary page 1…ActifuseTM Flow Bone Graft Substitute Common Name: Bone Graft Substitute Predicate Devices: Actifuse T M family of bone graft substitutes, K040082, K071206, K080736, K082073, K081979, K082575 Biomatlante MBCP, K060732, K051885 === Page… | 2007 |
| * | K080736 | Actifuse Shape Bone Graft SubstituteSummary page 1…itute Common Name: Bone Graft Substitute Predicate Devices: Actifuse T M family of bone graft substitutes, K040082, K071206, K080736, K082073, K081979, K082575 Biomatlante MBCP, K060732, K051885… | 2008 |
| * | K082073 | Actifuse Flow Bone Graft SubstituteSummary page 1…ommon Name: Bone Graft Substitute Predicate Devices: Actifuse T M family of bone graft substitutes, K040082, K071206, K080736, K082073, K081979, K082575 Biomatlante MBCP, K060732, K051885 IsoT… | 2008 |
| * | K081979 | Actifuse Bone Graft Substitute and E-Z-Fil and Shape Bone Graft SubstituteSummary page 1…e: Bone Graft Substitute Predicate Devices: Actifuse T M family of bone graft substitutes, K040082, K071206, K080736, K082073, K081979, K082575 Biomatlante MBCP, K060732, K051885 IsoTis OsSatu… | 2008 |
| * | K082575 | Actifuse Bone Graft Substitute and Abx E-Z-Fil and Shape Bone Graft SubstitutesSummary page 1…Bone Graft Substitute Predicate Devices: Actifuse T M family of bone graft substitutes, K040082, K071206, K080736, K082073, K081979, K082575 Biomatlante MBCP, K060732, K051885 IsoTis OsSatura, K0318… | 2008 |
| * | K060732 | MBCP GelSummary page 1…Actifuse T M family of bone graft substitutes, K040082, K071206, K080736, K082073, K081979, K082575 Biomatlante MBCP, K060732, K051885 IsoTis OsSatura, K031813, K042706 Intended use: Actifuse is a syntheti… | 2006 |
| * | K051885 | MBCPSummary page 1…se T M family of bone graft substitutes, K040082, K071206, K080736, K082073, K081979, K082575 Biomatlante MBCP, K060732, K051885 IsoTis OsSatura, K031813, K042706 Intended use: Actifuse is a synthetic bone gr… | 2005 |
| * | K031813 | Ossatura DentalSummary page 2…K080736, K082073, K081979, K082575 Biomatlante MBCP, K060732, K051885 IsoTis OsSatura, K031813, K042706 Intended use: Actifuse is a synthetic bone grafting material intended to fill, augment, and/or reconstruct maxillofac… | 2004 |
| * | K042706 | Ossatura DentalSummary page 2…K080736, K082073, K081979, K082575 Biomatlante MBCP, K060732, K051885 IsoTis OsSatura, K031813, K042706 Intended use: Actifuse is a synthetic bone grafting material intended to fill, augment, and/or reconstruct maxillofacial osseo… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 18, 2015 | Class II | Z-1922-2016 | Process control | Baxter Healthcare is issuing a voluntary recall for all lots of Actifuse ABX and Actifuse MIS System products with expiry before July 29, 2017 due to the possibility that the products may have endotoxin levels above specification criteria. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 22 ancestors have a recall of any class.
- 2 other devices also cite its predicate K040082.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Actifuse is a synthetic bone grafting material intended to fill, augment, and/or reconstruct
maxillofacial osseous bone defects including periodontal, oral and craniomaxillofacial
applications. These defects may be surgically created osseous defects or osseous defects
created from traumatic injury to the bone. The product provides a synthetic bone grafting
material that resorbs and is replaced by bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090850 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090850: Actifuse Bone Graft Substitute, Actifuse Microgranules Bone Graft Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090850
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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