510(k) · Cleared
ClearedGeistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich Perio System Combi Pack, Geistlic
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 Feb 15, 2013 as substantially equivalent to K112572 (Geistlich Pharma AG, 2011) and 5 other predicates after a 148-day review. Its family tree reaches back 5 generations to 1995. 21 later devices descend from it.
- Decided
- Feb 15, 2013
- Review
- 148 days
- Class
- Class II
- Product code
- NPM
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K924408 (1995). 15 ancestors in all, the oldest K871773 (1987). 21 later devices descend from it, 10 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 deviceK122894 Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit…Geistlich Pharma AG · 2013
- Descendant · cites it directly · 9 of its ownK192042 Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide…Geistlich Pharma AG · 2019
- Descendant · 2 generations on · 3 of its ownK212463 Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide…Geistlich Pharma AG · 2022
- Descendant · 2 generations on · 3 of its ownK210280 Geistlich Mucograft®, Geistlich Mucograft® SealGeistlich Pharma AG · 2021
- Descendant · cites it directly · 2 of its ownK240661 Geistlich Bio-Oss®Geistlich Pharma AG · 2024
- Descendant · 3 generations on · 0 of its ownK253317 Cytrans™ ElashieldGC America, Inc. · 2026
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K192042Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich…Geistlich Pharma AG · 2019 · cites it directly9descendants
- K212463Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich…Geistlich Pharma AG · 2022 · 2 generations on3descendants
- K210280Geistlich Mucograft®, Geistlich Mucograft® SealGeistlich Pharma AG · 2021 · 2 generations on3descendants
- K240661Geistlich Bio-Oss®Geistlich Pharma AG · 2024 · cites it directly2descendants
- K253317Cytrans™ ElashieldGC America, Inc. · 2026 · 3 generations on0descendants
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) | K122894 | Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen… | Geistlich Pharma AG | 2013 | — |
| +1 | K192042 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed… | Geistlich Pharma AG | 2019 | — |
| +2 | K212463 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed… | Geistlich Pharma AG | 2022 | — |
| +2 | K210280 | Geistlich Mucograft®, Geistlich Mucograft® Seal | Geistlich Pharma AG | 2021 | — |
| +1 | K240661 | Geistlich Bio-Oss® | Geistlich Pharma AG | 2024 | — |
| +3 | K253317 | Cytrans™ Elashield | GC America, Inc. | 2026 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 7 | 0 |
| 2026 | 2 | 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? (6)
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…Bone Grafting Material Classification Name: Bone grafting material, animal source (NPM) PREDICATE DEVICES Geistlich Bio-Oss® and Geistlich Bio-Oss® Blocks (K1 12572, K033815, K970321, K9526 18) DEVICE DESCRIPTION Geistlich Bio-Oss® spongiosa (cancellous) granules and Geistlich Bio-Oss® spongio… | 2011 |
| * | K033815 | Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenSummary page 1…e Grafting Material Classification Name: Bone grafting material, animal source (NPM) PREDICATE DEVICES Geistlich Bio-Oss® and Geistlich Bio-Oss® Blocks (K1 12572, K033815, K970321, K9526 18) DEVICE DESCRIPTION Geistlich Bio-Oss® spongiosa (cancellous) granules and Geistlich Bio-Oss® spongiosa (cance… | 2004 |
| * | K970321 | Bio-Oss Anorganic Bovine BoneSummary page 1…g Material Classification Name: Bone grafting material, animal source (NPM) PREDICATE DEVICES Geistlich Bio-Oss® and Geistlich Bio-Oss® Blocks (K1 12572, K033815, K970321, K9526 18) DEVICE DESCRIPTION Geistlich Bio-Oss® spongiosa (cancellous) granules and Geistlich Bio-Oss® spongiosa (cancellous) Bl… | 1998 |
| * | K952618 | Bio-OssSummary page 1…l Classification Name: Bone grafting material, animal source (NPM) PREDICATE DEVICES Geistlich Bio-Oss® and Geistlich Bio-Oss® Blocks (K1 12572, K033815, K970321, K9526 18) DEVICE DESCRIPTION Geistlich Bio-Oss® spongiosa (cancellous) granules and Geistlich Bio-Oss® spongiosa (cancellous) Block (refer… | 1995 |
| * | K092428 | Bio-Oss CollagenSummary page 4…Bone Grafting Material Plus Collagen Classification Name: Bone grafting material, animal source (NPM) PREDICATE DEVICES Geistlich Bio-Oss Collagen® (K1 12572, K092428, K033815, K974399) DEVICE DESCRIPTION GROC Geistlich Bio-Oss Collagene is a combination of purified spongiosa (cancellous) bone… | 2010 |
| * | K974399 | Bio-Oss CollagenSummary page 4…Material Plus Collagen Classification Name: Bone grafting material, animal source (NPM) PREDICATE DEVICES Geistlich Bio-Oss Collagen® (K1 12572, K092428, K033815, K974399) DEVICE DESCRIPTION GROC Geistlich Bio-Oss Collagene is a combination of purified spongiosa (cancellous) bone mineral granules (… | 1998 |
What descends from it? (21)
See all 2110 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192042 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich… | 2019 | 9 |
| K240661 | Geistlich Bio-Oss® | 2024 | 2 |
| K253723 | BOSS | 2026 | 0 |
| K242510 | Geistlich Bio-Flow® | 2025 | 0 |
| K230305 | THE Graft Collagen | 2024 | 0 |
| K231672 | S1 | 2023 | 0 |
| K211551 | Wishbone HA | 2021 | 0 |
| K193212 | DSM Biomedical Dental Bone Graft Plus | 2020 | 0 |
| K173594 | Straumann cerabone | 2018 | 0 |
| K163714 | Ossix Bone | 2017 | 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?
- The line of descent spans 18 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, K192042 (Geistlich Pharma AG, 2019) has gone furthest, with 9 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. 2013, 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 BioOS5e 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 Bane Regeneration (GER); and
- 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/K122894 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122894: Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich Perio System Combi Pack, Geistlic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122894
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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