510(k) · Cleared
ClearedHealos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model 6008, 6025
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Spine, Inc. · LYC Bone Grafting Material, Synthetic
Cleared on May 25, 2010 as substantially equivalent to K081432 (Depuy Spine, Inc., 2008) after a 208-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- May 25, 2010
- Review
- 208 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K960978 (1996). 35 ancestors in all, the oldest K852682 (1985). 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 backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 4 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 3 generations backK053387 Perioglas Bone Graft ParticulateNovabone Products, LLC · 2006
- 2 generations backK063596 Perioglas Putty-Bioactive Bone Graft GelNovabone Products, LLC · 2007
- 1 generation backK081432 Healos II Bone Graft SubstituteDepuy Spine, Inc. · 2008
- This deviceK093390 Healos Dental Bone Graft Substitute (Also Called Healos or Healos…Depuy Spine, Inc. · 2010
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 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −4 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −3 | K053387 | Perioglas Bone Graft Particulate | Novabone Products, LLC | 2006 | — |
| −2 | K063596 | Perioglas Putty-Bioactive Bone Graft Gel | Novabone Products, LLC | 2007 | — |
| −1 | K081432 | Healos II Bone Graft Substitute | Depuy Spine, Inc. | 2008 | — |
| 0 (this device) | K093390 | Healos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model… | Depuy Spine, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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? (1)
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 |
|---|---|---|---|
| * | K081432 | Healos II Bone Graft SubstituteSummary page 1…Number: 76 Product Code(s): LYC and NPM Proprietary Name: HEALOS Dental Bone Graft Substitute Predicate Devices: HEALOS Dental Bone Graft Substitute (K(081432) Device Description: HEALOS Dental Bone Graft Substitute is a mineralized collagen matrix processed into lyophilized strips or p… | 2008 |
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 14 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 35 ancestors has a recall of any class.
- 1 other device also cites its predicate K081432.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
HEALOS Dental Bone Graft Material ("HEALOS"), is intended to fill, augment, or reconstruct periodontal and/or bony defects of the upper or lower jaw. HEALOS is a bone graft substitute that is resorbed and remodeled into new bone as part of the natural healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093390 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093390: Healos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model 6008, 6025.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093390
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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