510(k) · Cleared
Recalled · Class II · 2022Osteoguide Anorganic Bone Mineral Products
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 Aug 4, 2005 as substantially equivalent to K033815 (Geistlich-Pharma, 2004) and 3 other predicates after a 274-day review. Its family tree reaches back 2 generations to 1987. 55 later devices descend from it. It has been recalled 3 times.
- Decided
- Aug 4, 2005
- Review
- 274 days
- Class
- Class II
- Product code
- NPM
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 2 generations to K871773 (1987). 8 ancestors in all. 55 later devices descend from it, 9 citing it directly.
- Root · 2 generations backK871773 Bio-Oss Pure Nat Hydroxyapatite Endoss ImplantGeistlich-Pharma · 1987
- 1 generation backK033815 Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenGeistlich-Pharma · 2004
- This deviceK043034 Osteoguide Anorganic Bone Mineral ProductsCollagen Matrix, Inc. · 2005
- Descendant · cites it directly · 40 of its ownK052812 Ossimend (TM) Bone Graft MaterialCollagen Matrix, Inc. · 2006
- Descendant · 2 generations on · 38 of its ownK082166 Mastergraft StripMedtronic Sofamor Danek · 2009
- Descendant · 3 generations on · 30 of its ownK140375 Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014
- Descendant · 4 generations on · 6 of its ownK181225 AltaporeBaxter Healthcare Corporation · 2018
- Descendant · 4 generations on · 4 of its ownK193075 Osteo3 ZP PuttySirakoss, Ltd. · 2020
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 55 · See all- K052812Ossimend (TM) Bone Graft MaterialCollagen Matrix, Inc. · 2006 · cites it directly40descendants
- K082166Mastergraft StripMedtronic Sofamor Danek · 2009 · 2 generations on38descendants
- K140375Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014 · 3 generations on30descendants
- K181225AltaporeBaxter Healthcare Corporation · 2018 · 4 generations on6descendants
- K193075Osteo3 ZP PuttySirakoss, Ltd. · 2020 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871773 | Bio-Oss Pure Nat Hydroxyapatite Endoss Implant | Geistlich-Pharma | 1987 | — |
| −1 | K033815 | Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen | Geistlich-Pharma | 2004 | — |
| 0 (this device) | K043034 | Osteoguide Anorganic Bone Mineral Products | Collagen Matrix, Inc. | 2005 | — |
| +1 | K052812 | Ossimend (TM) Bone Graft Material | Collagen Matrix, Inc. | 2006 | — |
| +2 | K082166 | Mastergraft Strip | Medtronic Sofamor Danek | 2009 | — |
| +3 | K140375 | Mastergraft Putty, Mastergraft Strip | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| +4 | K181225 | Altapore | Baxter Healthcare Corporation | 2018 | — |
| +4 | K193075 | Osteo3 ZP Putty | Sirakoss, Ltd. | 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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 7 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 8 | 0 |
| 2025 | 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? (4)
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 |
|---|---|---|---|
| * | K033815 | Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenSummary page 1…terial Unclassified NPM Predicate Device(s): Bio-Oss®, Bio-Oss® Blocks, Bio-Oss® Collagen, K033815 Bio-Oss® Granules, K952617 Bio-Oss® Blocks, K970569… | 2004 |
| * | K952617 | Bio-OssSummary page 1…NPM Predicate Device(s): Bio-Oss®, Bio-Oss® Blocks, Bio-Oss® Collagen, K033815 Bio-Oss® Granules, K952617 Bio-Oss® Blocks, K970569 Bio-Oss® Collagen, K974399 Descriptio… | 1995 |
| * | K970569 | Bio-BlocksSummary page 1…Bio-Oss®, Bio-Oss® Blocks, Bio-Oss® Collagen, K033815 Bio-Oss® Granules, K952617 Bio-Oss® Blocks, K970569 Bio-Oss® Collagen, K974399 Description of the Device "OsteoGuideTM Anorganic Bone Minera… | 2000 |
| * | K974399 | Bio-Oss CollagenSummary page 1…Bio-Oss® Granules, K952617 Bio-Oss® Blocks, K970569 Bio-Oss® Collagen, K974399 Description of the Device "OsteoGuideTM Anorganic Bone Mineral," "OsteoGuide CollagenTM Anorganic Bone Mineral with… | 1998 |
What descends from it? (55)
See all 559 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052812 | Ossimend (TM) Bone Graft Material | 2006 | 40 |
| K140714 | Porcine Anorganic Bone Mineral | 2014 | 4 |
| K072397 | Synoss Synthetic Bone Graft Material | 2007 | 3 |
| K240133 | Xenograft Bovine Bone Particulate | 2024 | 0 |
| K171008 | Anorganic Bone Mineral with Collagen in Delivery Applicator | 2017 | 0 |
| K170541 | Anorganic Bone Mineral in Delivery Applicator | 2017 | 0 |
| K083742 | Synoss Collagen Synthetic Mineral-Collagen Bone Graft Matrix | 2009 | 0 |
| K080772 | Bonemedik-DM | 2008 | 0 |
| K062200 | Collagen Matrix Anorganic Bone Mineral Bone Graft Materials | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 2, 2022 | Class II | Z-0823-2022 | Under Investigation by firm | NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair |
| Aug 25, 2015 | Class II | Z-1096-2016 | Unknown/Undetermined by firm | On 8/25/2015, Collagen Matrix, Inc discovered that one of the 171 units of NuOss Cancellous product shipped to a distributor may have included an incorrect size. |
| May 13, 2013 | Class II | Z-1097-2016 | Process control | During the 36 month real time shelf life testing of NuOss XC Sinus (BMCU-Umbrella) to verify the 3 year shelf life designated for the device, 3 of 13 products did not pass the recovery test, which requires that the compressed product… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 16.4 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K052812 (Collagen Matrix, Inc., 2006) has gone furthest, with 40 descendants of its own.
- 17 other devices also cite its predicate K033815.
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.
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?
Natural Mineral Bone Graft Substitutes are 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 periodontal defects
* Filling of defects after root resection, apicocectomy, 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/K043034 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043034: Osteoguide Anorganic Bone Mineral Products.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043034
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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