510(k) · Cleared
ClearedGeistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Geistlich Pharma AG · NPL Barrier, Animal Source, Intraoral
Cleared on Oct 30, 2017 as substantially equivalent to K112575 (Geistlich Pharma AG, 2011) after a 150-day review. Its family tree reaches back 5 generations to 1995. 10 later devices descend from it.
- Decided
- Oct 30, 2017
- Review
- 150 days
- Class
- Class II
- Product code
- NPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K924408 (1995). 15 ancestors in all, the oldest K871773 (1987). 10 later devices descend 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 backK112575 Geistlich Perio-System Combi-Pack , Geistlich Bio-Gide PerioGeistlich Pharma AG · 2011
- This deviceK171643 Geistlich Bio-Gide Shape, Geistlich Bio-Gide CompressedGeistlich Pharma AG · 2017
- 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 · 3 generations on · 0 of its ownK253317 Cytrans™ ElashieldGC America, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK250512 Augmented Gingival MatrixNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · 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
- K253317Cytrans™ ElashieldGC America, Inc. · 2026 · 3 generations on0descendants
- K250512Augmented Gingival MatrixNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. · 2025 · 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 | K112575 | Geistlich Perio-System Combi-Pack , Geistlich Bio-Gide Perio | Geistlich Pharma AG | 2011 | — |
| 0 (this device) | K171643 | Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed | Geistlich Pharma AG | 2017 | — |
| +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 | — |
| +3 | K253317 | Cytrans™ Elashield | GC America, Inc. | 2026 | — |
| +3 | K250512 | Augmented Gingival Matrix | Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. | 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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K112575 | Geistlich Perio-System Combi-Pack , Geistlich Bio-Gide PerioSummary page 5…Collagen Resorbable Bilayer Membrane Classification Name: Bone Grafting Material Product Code: NPL PREDICATE DEVICE Geistlich Bio-Gide® Perio (K112575) REFERENCE DEVICE Geistlich Bio-Gide® (K960724, K042197, K112572) DEVICE DESCRIPTION Geistlich Bio-Gide® Shape is a pure coll… | 2011 |
| † | K960724 | Bio-Gide Resorbable Bilayer Membrane | 1997 |
| † | K042197 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration | 2004 |
| † | K112572 | Geistlich Combi-Kit Collegen | 2011 |
What descends from it? (10)
1 later device cites 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 |
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 22 years and passes through 4 companies; a new generation was cleared every 5.3 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.
- 1 other device also cites its predicate K112575.
How does its category compare?
All NPL devicesNPL Barrier, Animal Source, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Geistlich Bio-Gide® Shape is indicated for: – augmentation around implants placed in immediate extraction sockets. – augmentation around implants placed in delayed extraction sockets. – localized ridge augmentation for later implantation. – alveolar ridge reconstruction for prosthetic treatment. – filling of bone defects after root resection, cystectomy, removal of retained teeth. – guided bone regeneration in dehiscence defects. Geistlich Bio-Gide®…
Read the full statement (124 words)
Geistlich Bio-Gide® Shape is indicated for:
– augmentation around implants placed in immediate extraction sockets.
– augmentation around implants placed in delayed extraction sockets.
– localized ridge augmentation for later implantation.
– alveolar ridge reconstruction for prosthetic treatment.
– filling of bone defects after root resection, cystectomy, removal of retained teeth.
– guided bone regeneration in dehiscence defects.
Geistlich Bio-Gide® Compressed is indicated for:
– augmentation around implants placed in immediate extraction sockets.
– augmentation around implants placed in delayed extraction sockets.
– localized ridge augmentation for later implantation.
– alveolar ridge reconstruction for prosthetic treatment.
– filling of bone defects after root resection, cystectomy, removal of retained teeth.
– guided bone regeneration in dehiscence defects.
– guided tissue regeneration procedures in periodontal defects
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171643: Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171643
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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