510(k) · Cleared
ClearedBioactys
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Graftys · LYC Bone Grafting Material, Synthetic
Cleared on Feb 24, 2009 as substantially equivalent to K051885 (Biomatlante, 2005) and 1 other predicate after a 197-day review. Its family tree reaches back 6 generations to 1999. 1 later device descends from it.
- Decided
- Feb 24, 2009
- Review
- 197 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K990131 (1999). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 backK051774 MBCPBiomatlante · 2006
- 1 generation backK073064 Graftys BCPGraftys · 2008
- This deviceK082286 BioactysGraftys · 2009
- Descendant · cites it directly · 0 of its ownK103820 Reprobone Dental Grafting MaterialCeramisys, Ltd. · 2011
Most influential descendants
Showing 1 of 1 · See all- K103820Reprobone Dental Grafting MaterialCeramisys, Ltd. · 2011 · cites it directly0descendants
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 | K051774 | MBCP | Biomatlante | 2006 | — |
| −1 | K073064 | Graftys BCP | Graftys | 2008 | — |
| 0 (this device) | K082286 | Bioactys | Graftys | 2009 | — |
| +1 | K103820 | Reprobone Dental Grafting Material | Ceramisys, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K051885 | MBCPSummary page 1…Legally Marketed Predicate'Device TM Predicate MBCP _Resorbable calcium salt bone void filler device [K051885] GRAFTYS®BCP- Resorbable calcium salt bone void filler device [K073064] 4. Device Description… | 2005 |
| * | K073064 | Graftys BCPSummary page 1…MBCP _Resorbable calcium salt bone void filler device [K051885] GRAFTYS®BCP- Resorbable calcium salt bone void filler device [K073064] 4. Device Description BIOACTYS® is a sterile single use bioresorbable bone void filling substitute. BIOACTYS… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103820 | Reprobone Dental Grafting Material | 2011 | 0 |
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 10 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K103820 (Ceramisys, Ltd., 2011) has gone furthest, with 0 descendants of its own.
- 13 other devices also cite its predicate K051885.
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?
Bioactys ® is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
These defects may be surgically created osseous or defects created from traumatic injury to bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082286 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082286: Bioactys.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082286
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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