510(k) · Cleared
ClearedThe Graft Bone Substitute
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Purgo Biologics, Inc. · NPM Bone Grafting Material, Animal Source
Cleared on Feb 14, 2020 as substantially equivalent to K173188 (Purgo Biologics, Inc., 2018) and 1 other predicate after a 231-day review. Its family tree reaches back 5 generations to 1987.
- Decided
- Feb 14, 2020
- Review
- 231 days
- Class
- Class II
- Product code
- NPM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K871773 (1987). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK871773 Bio-Oss Pure Nat Hydroxyapatite Endoss ImplantGeistlich-Pharma · 1987
- 4 generations backK033815 Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenGeistlich-Pharma · 2004
- 3 generations backK043034 Osteoguide Anorganic Bone Mineral ProductsCollagen Matrix, Inc. · 2005 · Recalled
- 2 generations backK140714 Porcine Anorganic Bone MineralCollagen Matrix, Inc. · 2014 · Recalled
- 1 generation backK162158 Porcine Anorganic Bone Mineral in Delivery ApplicatorCollagen Matrix, Inc. · 2017
- This deviceK191737 The Graft Bone SubstitutePurgo Biologics, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K871773 | Bio-Oss Pure Nat Hydroxyapatite Endoss Implant | Geistlich-Pharma | 1987 | — |
| −4 | K033815 | Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen | Geistlich-Pharma | 2004 | — |
| −3 | K043034 | Osteoguide Anorganic Bone Mineral Products | Collagen Matrix, Inc. | 2005 | 3 |
| −2 | K140714 | Porcine Anorganic Bone Mineral | Collagen Matrix, Inc. | 2014 | 2 |
| −1 | K162158 | Porcine Anorganic Bone Mineral in Delivery Applicator | Collagen Matrix, Inc. | 2017 | — |
| 0 (this device) | K191737 | The Graft Bone Substitute | Purgo Biologics, Inc. | 2020 | — |
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 |
| 2018 | 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 |
|---|---|---|---|
| * | K173188 | The Graft Natural Bone SubstituteSummary page 4…0 • Device Class: Class II • Date Prepared: 02/13/2020 Predicate Devices: The subject device is substantially equivalent to the following predicate devices: • K173188, The Graft Bone Substitute by Purgo Biologics Inc. • K162158, Porcine Anorganic Bone Mineral in Delivery Applicator by Collage… | 2018 |
| * | K162158 | Porcine Anorganic Bone Mineral in Delivery ApplicatorSummary page 4…redicate Devices: The subject device is substantially equivalent to the following predicate devices: • K173188, The Graft Bone Substitute by Purgo Biologics Inc. • K162158, Porcine Anorganic Bone Mineral in Delivery Applicator by Collagen Matrix Inc. Indication for Use: THE Graft Bone Substitute is… | 2017 |
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 33 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 12 ancestors have a recall of any class.
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. 2020, 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?
The Graft Bone Substitute is intended for use as a bone grafting material in dental surgery such as:
- Filling of extraction sockets to enhance preservation of the alveolar ridge
- Elevation of maxillary sinus floor
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191737 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191737: The Graft Bone Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191737
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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