510(k) · Cleared
Recalled · Class II · 2020Geistlich Bio-Oss Pen (0.25 G, 0.25-1.0MM Granules), Geistlich Bio-Oss Pen (0.5 G, 0.25-1.0MM Granules), Geistlich Bio-O
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 May 24, 2012 as substantially equivalent to K112572 (Geistlich Pharma AG, 2011) and 1 other predicate after an 86-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it. It has been recalled 6 times.
- Decided
- May 24, 2012
- Review
- 86 days
- Class
- Class II
- Product code
- NPM
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 5 generations to K924408 (1995). 15 ancestors in all, the oldest K871773 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK924408 Colla-Tec Absorbable Collagen MembraneColla-Tec, Inc. · 1995 · Recalled
- 4 generations backK992216 Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable…Integra Lifesciences Corp. · 1999 · Recalled
- 3 generations backK042197 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone…Ed. Geistlich Soehne AG Fuer Chemische Industrie · 2004
- 2 generations backK050446 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneEd. Geistlich Soehne AG Fuer Chemische Industrie · 2005
- 1 generation backK112572 Geistlich Combi-Kit CollegenGeistlich Pharma AG · 2011
- This deviceK120601 Geistlich Bio-Oss Pen (0.25 G, 0.25-1.0MM Granules), Geistlich…Geistlich Pharma AG · 2012
- Descendant · cites it directly · 0 of its ownK251786 Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®Geistlich Pharma AG · 2025
Most influential descendants
Showing 1 of 1 · See all- K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®Geistlich Pharma AG · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K924408 | Colla-Tec Absorbable Collagen Membrane | Colla-Tec, Inc. | 1995 | 2 |
| −4 | K992216 | Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen… | Integra Lifesciences Corp. | 1999 | 1 |
| −3 | K042197 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2004 | — |
| −2 | K050446 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2005 | — |
| −1 | K112572 | Geistlich Combi-Kit Collegen | Geistlich Pharma AG | 2011 | — |
| 0 (this device) | K120601 | Geistlich Bio-Oss Pen (0.25 G, 0.25-1.0MM Granules), Geistlich Bio-Oss Pen… | Geistlich Pharma AG | 2012 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K112572 | Geistlich Combi-Kit CollegenSummary page 1…mon/Usual Names: Natural Bone Grafting Material Classification Name: Bone grafting material, animal source (NPM) PREDICATE DEVICES Geistlich Bio-Oss® (K1 12572, K03381 5) RTR Syringe (K063634) DEVICE DESCRIPTION Geistlich Bio-Oss® spongiosa (cancellous) granules are natural non-antigenic… | 2011 |
| * | K033815 | Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenSummary page 1…Names: Natural Bone Grafting Material Classification Name: Bone grafting material, animal source (NPM) PREDICATE DEVICES Geistlich Bio-Oss® (K1 12572, K03381 5) RTR Syringe (K063634) DEVICE DESCRIPTION Geistlich Bio-Oss® spongiosa (cancellous) granules are natural non-antigenic porous bo… | 2004 |
| † | K063634 | RTR Syringe | 2007 |
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 |
|---|---|---|---|
| K251786 | Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 19, 2020 | Class II | Z-0490-2021 | Device Design | Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly in use for the sinus lift indication and while unlikely… |
| Oct 19, 2020 | Class II | Z-0491-2021 | Device Design | Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly in use for the sinus lift indication and while unlikely… |
| Oct 19, 2020 | Class II | Z-0492-2021 | Device Design | Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly in use for the sinus lift indication and while unlikely… |
| Apr 12, 2019 | Class II | Z-2146-2019 | Under Investigation by firm | When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen. |
| Apr 12, 2019 | Class II | Z-2145-2019 | Under Investigation by firm | When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen. |
| Apr 12, 2019 | Class II | Z-2147-2019 | Under Investigation by firm | When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K251786 (Geistlich Pharma AG, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K112572.
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. 2012, 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 pen-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120601 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120601: Geistlich Bio-Oss Pen (0.25 G, 0.25-1.0MM Granules), Geistlich Bio-Oss Pen (0.5 G, 0.25-1.0MM Granules), Geistlich Bio-O.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120601
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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