510(k) · Cleared
ClearedOptium DBM Gel and Putty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifenet · MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Cleared on Nov 28, 2005 as substantially equivalent to K020895 (Wrightmedicaltechnologyinc, 2004) and 3 other predicates after a 25-day review. Its family tree reaches back 2 generations to 1997. 39 later devices descend from it.
- Decided
- Nov 28, 2005
- Review
- 25 days
- Class
- Class II
- Product code
- MBP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K963562 (1997). 7 ancestors in all. 39 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK963562 Wright Plaster of Paris PelletsWrightmedicaltechnologyinc · 1997
- 1 generation backK020078 Exactech Resorbable Bone PasteExactech, Inc. · 2004
- This deviceK053098 Optium DBM Gel and PuttyLifenet · 2005
- Descendant · cites it directly · 34 of its ownK063050 Cap PlusEtex Corp. · 2007
- Descendant · cites it directly · 29 of its ownK080329 Cap Plus, Equivabone, Cap/DBMEtex Corp. · 2008
- Descendant · 2 generations on · 28 of its ownK090310 EquivaboneEtex Corp. · 2009
- Descendant · 2 generations on · 25 of its ownK090855 Equivabone Osteoinductive Bone Graft SubstituteEtex Corp. · 2009
- Descendant · 3 generations on · 21 of its ownK093447 CarrigenEtex Corp. · 2010
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K063050Cap PlusEtex Corp. · 2007 · cites it directly34descendants
- K080329Cap Plus, Equivabone, Cap/DBMEtex Corp. · 2008 · cites it directly29descendants
- K090310EquivaboneEtex Corp. · 2009 · 2 generations on28descendants
- K090855Equivabone Osteoinductive Bone Graft SubstituteEtex Corp. · 2009 · 2 generations on25descendants
- K093447CarrigenEtex Corp. · 2010 · 3 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963562 | Wright Plaster of Paris Pellets | Wrightmedicaltechnologyinc | 1997 | — |
| −1 | K020078 | Exactech Resorbable Bone Paste | Exactech, Inc. | 2004 | — |
| 0 (this device) | K053098 | Optium DBM Gel and Putty | Lifenet | 2005 | — |
| +1 | K063050 | Cap Plus | Etex Corp. | 2007 | — |
| +1 | K080329 | Cap Plus, Equivabone, Cap/DBM | Etex Corp. | 2008 | — |
| +2 | K090310 | Equivabone | Etex Corp. | 2009 | — |
| +2 | K090855 | Equivabone Osteoinductive Bone Graft Substitute | Etex Corp. | 2009 | — |
| +3 | K093447 | Carrigen | Etex Corp. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 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? (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 |
|---|---|---|---|
| * | K020895 | Allomatrix Model# 86Summary page 1…characteristics as described below for Allomatrix® Putty (K020895 / K041168), Osteofil® various… | 2004 |
| * | K041168 | Allomatrix PuttySummary page 1…as described below for Allomatrix® Putty (K020895 / K041168), Osteofil® various forms (K043420) and… | 2004 |
| * | K043420 | Osteofil, Optefil, Regenafil, Rti Allograft PasteSummary page 1…trix® Putty (K020895 / K041168), Osteofil® various forms (K043420) and Exactech Resorbable Bone… | 2005 |
| * | K020078 | Exactech Resorbable Bone PasteSummary page 1…forms (K043420) and Exactech Resorbable Bone Paste (K020078). Page 1 of 4 5809 Ward Court Virginia Beach, VA 23455 T… | 2004 |
What descends from it? (39)
See all 394 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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K063050 (Etex Corp., 2007) has gone furthest, with 34 descendants of its own.
- 9 other devices also cite its predicate K020895.
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?
These products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into the bony voids or gaps of the skeletal system (e.g., extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. These products provide a bone void filler that remodels into the recipient's skeletal system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053098 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053098: Optium DBM Gel and Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053098
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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