510(k) · Cleared
ClearedOssix Volumax
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datum Dental, Ltd. · NPL Barrier, Animal Source, Intraoral
Cleared on Aug 4, 2016 as substantially equivalent to K053260 (Colbar Lifescience, Ltd., 2006) after a 237-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Aug 4, 2016
- Review
- 237 days
- Class
- Class II
- Product code
- NPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K053260 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK053260 Ossix -PlusColbar Lifescience, Ltd. · 2006
- This deviceK153549 Ossix VolumaxDatum Dental, Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K053260 | Ossix -Plus | Colbar Lifescience, Ltd. | 2006 | — |
| 0 (this device) | K153549 | Ossix Volumax | Datum Dental, Ltd. | 2016 | — |
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 NPL? 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 NPL device
- #1 K212463 Geistlich Bio-Gide, Geistlich Bio-Gide Shape…score 14.5 · 9 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 |
|---|---|---|---|
| * | K053260 | Ossix -PlusSummary page 4…ial (21 CFR 872.3930) Regulatory class: II Product code: NPL (Barrier, Animal Source, Intraoral) III. Predicate Device Primary predicate: OSSIX® PLUS (K053260) Reference device: Mucograft® (K073711, K102531, K140518) IV. Device Description OSSIX® VOLUMAX is a biodegradable and biocomp… | 2006 |
| † | K073711 | Mucograft Collagen Matrix | 2008 |
| † | K102531 | Mucograft | 2010 |
| † | K140518 | Geistlich Mucograft: 15 X 20 MM, 20 X 30 MM, 8 MM Diameter | 2014 |
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?
- Its one ancestor has no recall.
- 8 other devices also cite its predicate K053260.
How does its category compare?
All NPL devicesNPL Barrier, Animal Source, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · NPL
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NPL
132in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NPL
6in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NPL
39in 2025
MAUDE reports naming product code NPL, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 172 | 0 | 0 |
| 2009 | 3 | 193 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 4 | 286 | 0 | 0 |
| 2012 | 0 | — | 3 | 3 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 5 | 140 | 0 | 3 |
| 2015 | 1 | — | 0 | 5 |
| 2016 | 3 | 184 | 0 | 9 |
| 2017 | 3 | 200 | 0 | 18 |
| 2018 | 1 | — | 0 | 14 |
| 2019 | 1 | — | 6 | 22 |
| 2020 | 2 | — | 0 | 8 |
| 2021 | 2 | — | 0 | 11 |
| 2022 | 3 | 290 | 0 | 19 |
| 2023 | 2 | — | 0 | 5 |
| 2024 | 3 | 263 | 0 | 20 |
| 2025 | 5 | 132 | 0 | 39 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
OSSIX® VOLUMAX is a resorbable collagen membrane intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for: - Ridge augmentation for later implant insertions. - Simultaneous ridge augmentation and implant insertions. - Ridge augmentation around implants inserted in delayed extraction sites. - Ridge augmentation around implants inserted in immediate extraction sites. -…
Read the full statement (134 words)
OSSIX® VOLUMAX is a resorbable collagen membrane intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for:
- Ridge augmentation for later implant insertions.
- Simultaneous ridge augmentation and implant insertions.
- Ridge augmentation around implants inserted in delayed extraction sites.
- Ridge augmentation around implants inserted in immediate extraction sites.
- Alveolar ridge preservation consequent to tooth (teeth) extraction(s).
- Over the window in lateral window sinus elevation procedure.
- In implants with vertical bone loss due to infection, only in cases where satisfactory debridement and implant surface disinfection can be achieved.
- In intra bony defects around teeth.
- For treatment of recession defects, together with coronally positioned flap.
- In furcation defects in multi rooted teeth.
- Localized gingival augmentation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153549 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153549: Ossix Volumax.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153549
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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