510(k) · Cleared
ClearedDBX Strip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Musculoskeletal Transplant Foundation · MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Cleared on Jan 13, 2006 after a 458-day review. The FDA summary names no predicate by number. 7 later devices descend from it.
- Decided
- Jan 13, 2006
- Review
- 458 days
- Class
- Class II
- Product code
- MBP
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 4 citing it directly.
- This deviceK042829 DBX StripMusculoskeletal Transplant Foundation · 2006
- Descendant · cites it directly · 6 of its ownK062205 DBX StripMusculoskeletal Transplant Foundation · 2007
- Descendant · cites it directly · 3 of its ownK113167 MTF New Bone Voild FillerMusculoskeletal Transplant Foundation · 2012
- Descendant · cites it directly · 3 of its ownK110003 MTF New Bone Void FillerMusculoskeletal Transplant Foundation · 2011
- Descendant · 2 generations on · 1 of its ownK121989 Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC)…Exactech, Inc. · 2012
- Descendant · 3 generations on · 0 of its ownK241555 Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K062205DBX StripMusculoskeletal Transplant Foundation · 2007 · cites it directly6descendants
- K113167MTF New Bone Voild FillerMusculoskeletal Transplant Foundation · 2012 · cites it directly3descendants
- K110003MTF New Bone Void FillerMusculoskeletal Transplant Foundation · 2011 · cites it directly3descendants
- K121989Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone…Exactech, Inc. · 2012 · 2 generations on1descendant
- K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042829 | DBX Strip | Musculoskeletal Transplant Foundation | 2006 | — |
| +1 | K062205 | DBX Strip | Musculoskeletal Transplant Foundation | 2007 | — |
| +1 | K113167 | MTF New Bone Voild Filler | Musculoskeletal Transplant Foundation | 2012 | — |
| +1 | K110003 | MTF New Bone Void Filler | Musculoskeletal Transplant Foundation | 2011 | — |
| +2 | K121989 | Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure +… | Exactech, Inc. | 2012 | — |
| +3 | K241555 | Moldable Bone Void Filler and Moldable Bone Void Filler + CCC | Rti Surgical, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2025 | 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?
The FDA summary names no predicate by number.
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K062205 (Musculoskeletal Transplant Foundation, 2007) has gone furthest, with 6 descendants of its own.
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.
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?
DBX® Strip is indicated as a bone void filler in the spine for the treatment of surgically created osseous voids or gaps that are not intrinsic to the stability of the bony structure.
DBX Strip is indicated for use in the posterior elements of the spine for posterolateral fusion only.
DBX Strip is for singzle patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042829 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042829: DBX Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042829
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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