510(k) · Cleared
ClearedPorcine Anorganic Bone Mineral in Delivery Applicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Collagen Matrix, Inc. · NPM Bone Grafting Material, Animal Source
Cleared on Feb 9, 2017 as substantially equivalent to K140714 (Collagen Matrix, Inc., 2014) after a 191-day review. Its family tree reaches back 4 generations to 1987. 1 later device descends from it.
- Decided
- Feb 9, 2017
- Review
- 191 days
- Class
- Class II
- Product code
- NPM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K871773 (1987). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK871773 Bio-Oss Pure Nat Hydroxyapatite Endoss ImplantGeistlich-Pharma · 1987
- 3 generations backK033815 Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenGeistlich-Pharma · 2004
- 2 generations backK043034 Osteoguide Anorganic Bone Mineral ProductsCollagen Matrix, Inc. · 2005 · Recalled
- 1 generation backK140714 Porcine Anorganic Bone MineralCollagen Matrix, Inc. · 2014 · Recalled
- This deviceK162158 Porcine Anorganic Bone Mineral in Delivery ApplicatorCollagen Matrix, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK191737 The Graft Bone SubstitutePurgo Biologics, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K191737The Graft Bone SubstitutePurgo Biologics, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871773 | Bio-Oss Pure Nat Hydroxyapatite Endoss Implant | Geistlich-Pharma | 1987 | — |
| −3 | K033815 | Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen | Geistlich-Pharma | 2004 | — |
| −2 | K043034 | Osteoguide Anorganic Bone Mineral Products | Collagen Matrix, Inc. | 2005 | 3 |
| −1 | K140714 | Porcine Anorganic Bone Mineral | Collagen Matrix, Inc. | 2014 | 2 |
| 0 (this device) | K162158 | Porcine Anorganic Bone Mineral in Delivery Applicator | Collagen Matrix, Inc. | 2017 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (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 |
|---|---|---|---|
| * | K140714 | Porcine Anorganic Bone MineralSummary page 4…ntal Legally Marketed Devices to Which Substantial Equivalence is Claimed Predicate Device(s) Porcine Anorganic Bone Mineral K140714 510(k) Summary K162158 Page 2 of… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191737 | The Graft Bone Substitute | 2020 | 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 30 years and passes through 2 companies; a new generation was cleared every 8.9 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K191737 (Purgo Biologics, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K140714.
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. 2017, 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?
Porcine Anorganic Bone Mineral in Delivery Applicator is intended for use in dental surgery. The products may be used in surgical procedures such as:
Augmentation or reconstructive treatment of 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162158: Porcine Anorganic Bone Mineral in Delivery Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162158
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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