510(k) · Cleared
ClearedNovabone-BBG-Resorbable Bone Graft Substitute
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novabone Products, LLC · LYC Bone Grafting Material, Synthetic
Cleared on Mar 25, 2004 as substantially equivalent to K992416 (Usbiomaterials Corp., 1999) and 4 other predicates after a 92-day review. Its family tree reaches back 2 generations to 1995. 85 later devices descend from it.
- Decided
- Mar 25, 2004
- Review
- 92 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K941780 (1995). 8 ancestors in all, the oldest K852682 (1985). 85 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK941780 Orthovita BiogranOrthovita Co. · 1995
- 1 generation backK962494 Perioglas - Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1996
- This deviceK033994 Novabone-BBG-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004
- Descendant · cites it directly · 84 of its ownK041613 Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004
- Descendant · 2 generations on · 59 of its ownK082672 Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008
- Descendant · 3 generations on · 47 of its ownK101860 Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC · 2010
- Descendant · 3 generations on · 43 of its ownK110368 Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011
- Descendant · 3 generations on · 38 of its ownK112773 Novabne Putty Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011
Showing 5 of 85 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 85 · See all- K041613Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004 · cites it directly84descendants
- K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008 · 2 generations on59descendants
- K101860Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC · 2010 · 3 generations on47descendants
- K110368Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011 · 3 generations on43descendants
- K112773Novabne Putty Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011 · 3 generations on38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941780 | Orthovita Biogran | Orthovita Co. | 1995 | — |
| −1 | K962494 | Perioglas - Bioglass Bone Graft Particulate | Usbiomaterials Corp. | 1996 | — |
| 0 (this device) | K033994 | Novabone-BBG-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2004 | — |
| +1 | K041613 | Novabone - AR - Resorbable Bone Graft Substitute | Novabone Products, LLC | 2004 | — |
| +2 | K082672 | Novabone Putty-Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2008 | — |
| +3 | K101860 | Novabone Putty- Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2010 | — |
| +3 | K110368 | Novabone Putty - Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2011 | — |
| +3 | K112773 | Novabne Putty Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 9 | 0 |
| 2024 | 9 | 0 |
| 2025 | 13 | 0 |
| 2026 | 7 | 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? (5)
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 |
|---|---|---|---|
| * | K992416 | Perioglas- Bioglass Bone Graft ParticulateSummary page 1…ni 3. Le-ally Marketed Predicate Device: Predicate #1: PerioGlas - Synthetic Bone Graft Particulate [K9924 16, K962492, K9301 151 (Also named as NovaBone per KOOO 149) Predicate #2:… | 1999 |
| * | K962494 | Perioglas - Bioglass Bone Graft Particulate Our reading of the summary gave K962492, FDA’s number for Silenzio Plus Continuous Positive Airway Pressure System (Nidek Medical Products, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “PerioGlas - Synthetic Bone Graft Particulate”. | 1996 |
| * | K930115 | PerioglassSummary page 1…Marketed Predicate Device: Predicate #1: PerioGlas - Synthetic Bone Graft Particulate [K9924 16, K962492, K9301 151 (Also named as NovaBone per KOOO 149) Predicate #2: Biogran - Bi… | 1993 |
| * | K000149 | Novabone-Bioglass Bone Graft Particulate | 2000 |
| * | K952922 | Biogran Bioactive Glass Synthetic Bone Graft MaterialSummary page 1…o named as NovaBone per KOOO 149) Predicate #2: Biogran - Bioactive Glass Synthetic Bone Graft NMatcrial [K952922] 4. Device Description NovaBone-BBG is a synthetic resorbable osteoconductive bonie graft Substitute composed o… | 1995 |
What descends from it? (85)
See all 851 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041613 | Novabone - AR - Resorbable Bone Graft Substitute | 2004 | 84 |
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 9 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K041613 (Novabone Products, LLC, 2004) has gone furthest, with 84 descendants of its own.
- 9 other devices also cite its predicate K992416.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
NovaBone-BBG - Resorbable Bone Graft Substitute is indicated to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/ maxillo-facial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including: periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance…
Read the full statement (146 words)
NovaBone-BBG - Resorbable Bone Graft Substitute is indicated to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/ maxillo-facial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including: periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. The device provides a bone void filler that resorbs and is replaced with bone during the healing process. NovaBone-BBG may be used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (demineralized freeze dried bone), or it may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. NovaBone-BBG is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033994 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033994: Novabone-BBG-Resorbable Bone Graft Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033994
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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