510(k) · Cleared
Recalled · Class II · 2019Osteoselect Demineralized Bone Matrix Putty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bacterin International, Inc. · MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Cleared on May 31, 2013 as substantially equivalent to K091321 (Bacterin International, Inc., 2009) and 2 other predicates after a 94-day review. Its family tree reaches back 2 generations to 2005. 1 later device descends from it. It has been recalled once.
- Decided
- May 31, 2013
- Review
- 94 days
- Class
- Class II
- Product code
- MBP
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K040262 (2005). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK040262 DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone…Musculoskeletal Transplant Foundation · 2005 · Recalled
- 1 generation backK091321 Osteoselect Demineralized Bone Matrix PuttyBacterin International, Inc. · 2009 · Recalled
- This deviceK130498 Osteoselect Demineralized Bone Matrix PuttyBacterin International, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK150621 OsteoSelect PLUS Demineralized Bone Matrix PuttyBacterin International, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K150621OsteoSelect PLUS Demineralized Bone Matrix PuttyBacterin International, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K040262 | DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix Mix | Musculoskeletal Transplant Foundation | 2005 | 2 |
| −1 | K091321 | Osteoselect Demineralized Bone Matrix Putty | Bacterin International, Inc. | 2009 | 2 |
| 0 (this device) | K130498 | Osteoselect Demineralized Bone Matrix Putty | Bacterin International, Inc. | 2013 | — |
| +1 | K150621 | OsteoSelect PLUS Demineralized Bone Matrix Putty | Bacterin International, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 MBP? 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 MBP device
- #1 K242799 PliaFX Floscore 9.0 · 3 generations · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K091321 | Osteoselect Demineralized Bone Matrix PuttySummary page 1…lass 11 Predicate Devices OsteoSelect® Demineralized Bone Matrix Putty Bacterin International, Inc. 510O(k) K091321 (use in extremities and pelvis) DBX® Demnineralized Bone Matrix Putty Musculoskeletal Tr… | 2009 |
| * | K103784 | DBX Demineralized Bone Matrix PuttySummary page 1…(use in extremities and pelvis) DBX® Demnineralized Bone Matrix Putty Musculoskeletal Transplant Foundation K103784 (use in pelvis and extremities) K103795 (use in posterolateral spine)… | 2011 |
| * | K103795 | DBX Demineralized Bone Matrix PuttySummary page 1…emnineralized Bone Matrix Putty Musculoskeletal Transplant Foundation K103784 (use in pelvis and extremities) K103795 (use in posterolateral spine) K1 30498 page 2of 3 Descri… | 2011 |
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 |
|---|---|---|---|
| K150621 | OsteoSelect PLUS Demineralized Bone Matrix Putty | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 3, 2019 | Class II | Z-1526-2020 | Labeling Change Control | The firm received one customer complaint concerning three OsteoSelect Demineralized Bone Matrix (DBM) devices which contained 5.0cc of putty, instead of 10.00cc of putty as labeled. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K150621 (Bacterin International, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K091321.
How does its category compare?
All MBP devicesMBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MBP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MBP
181in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBP
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBP
2in 2025
MAUDE reports naming product code MBP, 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 | 5 | 188 | 0 | 7 |
| 2008 | 5 | 93 | 0 | 15 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 0 | — | 0 | 14 |
| 2011 | 1 | — | 2 | 18 |
| 2012 | 1 | — | 13 | 24 |
| 2013 | 3 | 181 | 0 | 16 |
| 2014 | 0 | — | 1 | 15 |
| 2015 | 1 | — | 0 | 11 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 7 | 6 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
OsteoSelect® DBMV Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony strtucture. OsteoSelect® OBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect® DBM Putty can be used as follows:
a Extremities
* Posterolateral spine
* Pelvis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130498 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130498: Osteoselect Demineralized Bone Matrix Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130498
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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