510(k) · Cleared
ClearedInterOss
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sigmagraft, Inc. · NPM Bone Grafting Material, Animal Source
Cleared on Nov 6, 2015 as substantially equivalent to K970321 (Geistlich-Pharma, 1998) after a 184-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Nov 6, 2015
- Review
- 184 days
- Class
- Class II
- Product code
- NPM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970321 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK970321 Bio-Oss Anorganic Bovine BoneGeistlich-Pharma · 1998
- This deviceK151209 InterOssSigmagraft, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970321 | Bio-Oss Anorganic Bovine Bone | Geistlich-Pharma | 1998 | — |
| 0 (this device) | K151209 | InterOss | Sigmagraft, Inc. | 2015 | — |
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? (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 |
|---|---|---|---|
| * | K970321 | Bio-Oss Anorganic Bovine BoneSummary page 4…Predicate Devices The subject device is substantially equivalent to the following predicate device: o Primary Predicate Device Bio-Oss® (K970321) manufactured by Geistlich Pharma AG. o Reference Predicate Device (Vial) OCS-B® (K113246) manufactur… | 1998 |
| † | K113246 | OCS-B | 2013 |
| † | K120601 | Geistlich Bio-Oss Pen (0.25 G, 0.25-1.0MM Granules), Geistlich Bio-Oss Pen (0.5 G… | 2012 |
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?
- Its one ancestor has no recall.
- 11 other devices also cite its predicate K970321.
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. 2015, 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?
InterOss® small granules are recommended for: • Augmentation or reconstructive treatment of the alveolar ridge • Filling of infrabony periodontal defects • Filling of defects after root resection, apicocectomy, 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…
Read the full statement (127 words)
InterOss® small granules are recommended for:
• Augmentation or reconstructive treatment of the alveolar ridge
• Filling of infrabony periodontal defects
• Filling of defects after root resection, apicocectomy, 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)
• Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
InterOss® large granules are recommended for:
• Augmentation or reconstructive treatment 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)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151209 · printed Nov 5, 2026
Cite this page
510(k) Report. “K151209: InterOss.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K151209
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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