510(k) · Cleared
ClearedOssix Plus
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 184-day review. Its family tree reaches back 1 generation to 2006. 1 later device descends from it.
- Decided
- Aug 4, 2016
- Review
- 184 days
- Class
- Class II
- Product code
- NPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K053260 (2006). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K212509OSSIX BreezeDatum Dental, Ltd. · 2022 · cites it directly0descendants
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) | K160281 | Ossix Plus | Datum Dental, Ltd. | 2016 | — |
| +1 | K212509 | OSSIX Breeze | Datum Dental, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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…agen Membrane Classification name: Bone grafting material (21 CFR 872.3930) Regulatory class: II Product code: NPL III. Predicate Device OSSIX® PLUS (K053260) IV. Device Description OSSIX® PLUS is a biodegradable and biocompatible collagen membrane intended for use during the process… | 2006 |
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 |
|---|---|---|---|
| K212509 | OSSIX Breeze | 2022 | 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?
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® PLUS 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…
Read the full statement (130 words)
OSSIX® PLUS 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160281: Ossix Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160281
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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