510(k) · Cleared
ClearedGeistlich Bio-Oss®; Geistlich Bio-Oss Pen®
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Geistlich Pharma AG · NPM Bone Grafting Material, Animal Source
Cleared on Jul 11, 2025 as substantially equivalent to K240661 (Geistlich Pharma AG, 2024) and 1 other predicate after a 30-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Jul 11, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- NPM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K924408 (1995). 18 ancestors in all, the oldest K871773 (1987). No later device cites it as a predicate yet.
- Root · 7 generations backK924408 Colla-Tec Absorbable Collagen MembraneColla-Tec, Inc. · 1995 · Recalled
- 6 generations backK992216 Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable…Integra Lifesciences Corp. · 1999 · Recalled
- 5 generations backK042197 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone…Ed. Geistlich Soehne AG Fuer Chemische Industrie · 2004
- 4 generations backK050446 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneEd. Geistlich Soehne AG Fuer Chemische Industrie · 2005
- 3 generations backK112572 Geistlich Combi-Kit CollegenGeistlich Pharma AG · 2011
- 2 generations backK122894 Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit…Geistlich Pharma AG · 2013
- 1 generation backK240661 Geistlich Bio-Oss®Geistlich Pharma AG · 2024
- This deviceK251786 Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®Geistlich Pharma AG · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K924408 | Colla-Tec Absorbable Collagen Membrane | Colla-Tec, Inc. | 1995 | 2 |
| −6 | K992216 | Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen… | Integra Lifesciences Corp. | 1999 | 1 |
| −5 | K042197 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2004 | — |
| −4 | K050446 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2005 | — |
| −3 | K112572 | Geistlich Combi-Kit Collegen | Geistlich Pharma AG | 2011 | — |
| −2 | K122894 | Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen… | Geistlich Pharma AG | 2013 | — |
| −1 | K240661 | Geistlich Bio-Oss® | Geistlich Pharma AG | 2024 | — |
| 0 (this device) | K251786 | Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® | Geistlich Pharma AG | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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 NPM? 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 NPM device
- #1 K240661 Geistlich Bio-Oss®score 15.2 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K240661 | Geistlich Bio-Oss®Summary page 5…NPM Device Classification II III. Predicate Device Substantial equivalence is claimed to the following device: • Geistlich Bio-Oss®, K240661, Geistlich Pharma AG • Geistlich Bio-Oss® Pen, K120601, Geistlich Pharma AG The following device is referenced within t… | 2024 |
| * | K120601 | Geistlich Bio-Oss Pen (0.25 G, 0.25-1.0MM Granules), Geistlich Bio-Oss Pen (0.5 G…Summary page 5…icate Device Substantial equivalence is claimed to the following device: • Geistlich Bio-Oss®, K240661, Geistlich Pharma AG • Geistlich Bio-Oss® Pen, K120601, Geistlich Pharma AG The following device is referenced within the submission: • Geistlich Bio-Flow®, K242510, Geistli… | 2012 |
| † | K242510 | Geistlich Bio-Flow® | 2025 |
| † | K122894 | Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich… | 2013 |
| † | K970321 | Bio-Oss Anorganic Bovine Bone | 1998 |
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 30 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 3 of the 18 ancestors have a recall of any class.
- 1 other device also cites its predicate K240661.
How does its category compare?
All NPM devicesNPM Bone Grafting Material, Animal Source: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · NPM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NPM
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NPM
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NPM
14in 2025
MAUDE reports naming product code NPM, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 3 | 112 | 0 | 0 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 3 |
| 2015 | 4 | 349 | 0 | 1 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 5 | 191 | 0 | 3 |
| 2018 | 2 | — | 1 | 8 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 3 | 231 | 3 | 3 |
| 2021 | 2 | — | 0 | 4 |
| 2022 | 0 | — | 1 | 27 |
| 2023 | 2 | — | 0 | 4 |
| 2024 | 3 | 211 | 0 | 5 |
| 2025 | 3 | 30 | 0 | 14 |
| 2026 | 3 | 269 | 0 | — |
What is it indicated for?
Geistlich Bio-Oss® is intended for the following uses:
» Augmentation or reconstructive treatment of the alveolar ridge;
» Filling of infrabony periodontal defects;
» Filling of defects after root resection, apicoectomy, and cystectomy;
» Filling of extraction sockets to enhance preservation of the alveolar ridge;
* Elevation of the maxillary sinus floor;
» Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and
» Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K251786 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251786: Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251786
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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