510(k) · Cleared
ClearedBio-Oss Collagen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ed. Geistlich Soehne AG Fuer Chemische Industrie · NPM Bone Grafting Material, Animal Source
Cleared on Mar 18, 2010 as substantially equivalent to K033815 (Geistlich-Pharma, 2004) and 1 other predicate after a 223-day review. Its family tree reaches back 2 generations to 1987. 29 later devices descend from it.
- Decided
- Mar 18, 2010
- Review
- 223 days
- Class
- Class II
- Product code
- NPM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K871773 (1987). 8 ancestors in all. 29 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK871773 Bio-Oss Pure Nat Hydroxyapatite Endoss ImplantGeistlich-Pharma · 1987
- 1 generation backK033815 Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenGeistlich-Pharma · 2004
- This deviceK092428 Bio-Oss CollagenEd. Geistlich Soehne AG Fuer Chemische Industrie · 2010
- Descendant · cites it directly · 23 of its ownK112572 Geistlich Combi-Kit CollegenGeistlich Pharma AG · 2011
- Descendant · cites it directly · 21 of its ownK122894 Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit…Geistlich Pharma AG · 2013
- Descendant · cites it directly · 11 of its ownK112575 Geistlich Perio-System Combi-Pack , Geistlich Bio-Gide PerioGeistlich Pharma AG · 2011
- Descendant · 2 generations on · 10 of its ownK171643 Geistlich Bio-Gide Shape, Geistlich Bio-Gide CompressedGeistlich Pharma AG · 2017
- Descendant · 2 generations on · 9 of its ownK192042 Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide…Geistlich Pharma AG · 2019
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K112572Geistlich Combi-Kit CollegenGeistlich Pharma AG · 2011 · cites it directly23descendants
- K122894Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich…Geistlich Pharma AG · 2013 · cites it directly21descendants
- K112575Geistlich Perio-System Combi-Pack , Geistlich Bio-Gide PerioGeistlich Pharma AG · 2011 · cites it directly11descendants
- K171643Geistlich Bio-Gide Shape, Geistlich Bio-Gide CompressedGeistlich Pharma AG · 2017 · 2 generations on10descendants
- K192042Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich…Geistlich Pharma AG · 2019 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871773 | Bio-Oss Pure Nat Hydroxyapatite Endoss Implant | Geistlich-Pharma | 1987 | — |
| −1 | K033815 | Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen | Geistlich-Pharma | 2004 | — |
| 0 (this device) | K092428 | Bio-Oss Collagen | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2010 | — |
| +1 | K112572 | Geistlich Combi-Kit Collegen | Geistlich Pharma AG | 2011 | — |
| +1 | K122894 | Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen… | Geistlich Pharma AG | 2013 | — |
| +1 | K112575 | Geistlich Perio-System Combi-Pack , Geistlich Bio-Gide Perio | Geistlich Pharma AG | 2011 | — |
| +2 | K171643 | Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed | Geistlich Pharma AG | 2017 | — |
| +2 | K192042 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed… | Geistlich Pharma AG | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 7 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K033815 | Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenSummary page 2…ical changes were made. The rest of the manufacturing process is identical to that reviewed in prior 510(k) notifications for this product (K974399 and K033815). Importantly, the principal virus inactivation step does not change. To substantiate that the change in the a… | 2004 |
| * | K974399 | Bio-Oss CollagenSummary page 2…ion or technical changes were made. The rest of the manufacturing process is identical to that reviewed in prior 510(k) notifications for this product (K974399 and K033815). Importantly, the principal virus inactivation step does not change. To substantiate that the cha… | 1998 |
What descends from it? (29)
See all 294 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 2 companies; a new generation was cleared every 16.4 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K112572 (Geistlich Pharma AG, 2011) has gone furthest, with 23 descendants of its own.
- 17 other devices also cite its predicate K033815.
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. 2010, 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?
Augmentation or reconstructive treatment of alveolar ridge
Filling of periodontal defects
Filling of defects after root resection, apicoectomy, and cystectomny
Filling of extraction sockets to enhance preservation of the alveolar ridge
Elevation of maxillary sinus floor
Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
Filling of peni-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/K092428 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092428: Bio-Oss Collagen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092428
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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