510(k) · Cleared
ClearedHealos II Bone Graft Substitute
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 Aug 29, 2008 as substantially equivalent to K012751 (Orquest, Inc., 2001) and 6 other predicates after a 100-day review. Its family tree reaches back 6 generations to 1996. 3 later devices descend from it.
- Decided
- Aug 29, 2008
- Review
- 100 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 6 generations to K960978 (1996). 34 ancestors in all, the oldest K852682 (1985). 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 5 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 4 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 3 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 2 generations backK053387 Perioglas Bone Graft ParticulateNovabone Products, LLC · 2006
- 1 generation backK063596 Perioglas Putty-Bioactive Bone Graft GelNovabone Products, LLC · 2007
- This deviceK081432 Healos II Bone Graft SubstituteDepuy Spine, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK101827 OsteoscafTexas Innovative Medical Devices (Dba) Skeletal · 2011
- Descendant · 2 generations on · 0 of its ownK213260 CMFlexTMDimension Inx Corp. · 2022
- Descendant · cites it directly · 0 of its ownK093390 Healos Dental Bone Graft Substitute (Also Called Healos or Healos…Depuy Spine, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See all- K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal · 2011 · cites it directly1descendant
- K213260CMFlexTMDimension Inx Corp. · 2022 · 2 generations on0descendants
- K093390Healos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model 6008, 6025Depuy Spine, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −5 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −4 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −3 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −2 | K053387 | Perioglas Bone Graft Particulate | Novabone Products, LLC | 2006 | — |
| −1 | K063596 | Perioglas Putty-Bioactive Bone Graft Gel | Novabone Products, LLC | 2007 | — |
| 0 (this device) | K081432 | Healos II Bone Graft Substitute | Depuy Spine, Inc. | 2008 | — |
| +1 | K101827 | Osteoscaf | Texas Innovative Medical Devices (Dba) Skeletal | 2011 | — |
| +2 | K213260 | CMFlexTM | Dimension Inx Corp. | 2022 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2022 | 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? (7)
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 |
|---|---|---|---|
| * | K012751 | Healos Bone Graft MaterialSummary page 1…l FDA Panel Number: 76 Product Code(s): LYC Proprietary Name: HEALOS Bone Graft Substitute Predicate Devices: HEALOS Bone Graft Substitute (K012751, K043308) Novabone Putty Resorb able Bone Void Filler (K051617) NovaBone Dent… | 2001 |
| * | K043308 | Modification to: Healos Bone Graft MaterialSummary page 1…DA Panel Number: 76 Product Code(s): LYC Proprietary Name: HEALOS Bone Graft Substitute Predicate Devices: HEALOS Bone Graft Substitute (K012751, K043308) Novabone Putty Resorb able Bone Void Filler (K051617) NovaBone Dental Putty… | 2005 |
| * | K051617 | Novabone Putty - Resorbable Bone Void FillerSummary page 1…S Bone Graft Substitute Predicate Devices: HEALOS Bone Graft Substitute (K012751, K043308) Novabone Putty Resorb able Bone Void Filler (K051617) NovaBone Dental Putty (K063596) Bio-Oss Collagen Blocks (K0338 15)… | 2006 |
| * | K063596 | Perioglas Putty-Bioactive Bone Graft GelSummary page 1…Bone Graft Substitute (K012751, K043308) Novabone Putty Resorb able Bone Void Filler (K051617) NovaBone Dental Putty (K063596) Bio-Oss Collagen Blocks (K0338 15) Orthoss Resorbable Bone Void Filler (K014… | 2007 |
| * | K033815 | Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenSummary page 1…Novabone Putty Resorb able Bone Void Filler (K051617) NovaBone Dental Putty (K063596) Bio-Oss Collagen Blocks (K0338 15) Orthoss Resorbable Bone Void Filler (K014289) Collagraft Strip Bone Graft Ma… | 2004 |
| * | K014289 | Orthoss Resorbable Bone Void FillerSummary page 1…NovaBone Dental Putty (K063596) Bio-Oss Collagen Blocks (K0338 15) Orthoss Resorbable Bone Void Filler (K014289) Collagraft Strip Bone Graft Matrix (KOOO0122) Device Description: HEALOS is a mineralized collag… | 2002 |
| * | K000122 | Collagraft Strip Bone Graft Matrix (for Use as a Bone Filler), Model 1X,3X,6X (1,3 or 6… | 2001 |
What descends from it? (3)
2 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?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 34 ancestors has a recall of any class.
- Of its descendants, K101827 (Texas Innovative Medical Devices (Dba) Skeletal, 2011) has gone furthest, with 1 descendant of its own.
- 10 other devices also cite its predicate K012751.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Bone Graft Material ("HEALOS") is intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw. The product provides a bone void filler that is resorbed and remodeled into new bone as part of the natural process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081432 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081432: Healos II Bone Graft Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081432
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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