510(k) · Cleared
ClearedOptecure
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Cleared on Feb 8, 2006 as substantially equivalent to K040755 (Exactech, Inc., 2004) and 3 other predicates after a 315-day review. Its family tree reaches back 4 generations to 1999. 3 later devices descend from it.
- Decided
- Feb 8, 2006
- Review
- 315 days
- Class
- Class II
- Product code
- MBP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K990131 (1999). 12 ancestors in all, the oldest K963562 (1997). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 3 generations backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
- 2 generations backK032268 MBCPBiomatlante · 2003
- 1 generation backK043005 Modification to MBCPBiomatlante · 2005
- This deviceK050806 OptecureExactech, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK061668 Optecure +CCCExactech, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK121989 Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC)…Exactech, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK241555 Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See all- K061668Optecure +CCCExactech, Inc. · 2006 · cites it directly2descendants
- K121989Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone…Exactech, Inc. · 2012 · cites it directly1descendant
- K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute | Interpore Cross Intl. | 1999 | — |
| −3 | K020986 | Mastergraft Resorbable Ceramic | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −2 | K032268 | MBCP | Biomatlante | 2003 | — |
| −1 | K043005 | Modification to MBCP | Biomatlante | 2005 | — |
| 0 (this device) | K050806 | Optecure | Exactech, Inc. | 2006 | — |
| +1 | K061668 | Optecure +CCC | Exactech, Inc. | 2006 | — |
| +1 | K121989 | Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure +… | Exactech, Inc. | 2012 | — |
| +2 | K241555 | Moldable Bone Void Filler and Moldable Bone Void Filler + CCC | Rti Surgical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2012 | 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? (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 |
|---|---|---|---|
| * | K040755 | Exactech Resorbable Room Temperature Bone PasteSummary page 2…lence Comparison: Product Code Manufacturer 510(k) Product Number MQV, MBP Exactech Inc. K040755 Exactech Resorbable Bone Paste MQV Regeneration… | 2004 |
| * | K043420 | Osteofil, Optefil, Regenafil, Rti Allograft PasteSummary page 2…Exactech Inc. K040755 Exactech Resorbable Bone Paste MQV Regeneration K043420 Regenafil Allograft Paste, Technologies Inc Regenafil RT Paste, Osteofil,… | 2005 |
| * | K043005 | Modification to MBCP Cleared while this submission was under review Summary page 2…Regenafil RT Paste, Osteofil, Optefil, RTI Allograft Paste MQV Biomatlante K043005 MBCP MQV Wright Medical K020895 Allomatrix Technologies 4. Comparison to… | 2005 |
| * | K020895 | Allomatrix Model# 86Summary page 2…Optefil, RTI Allograft Paste MQV Biomatlante K043005 MBCP MQV Wright Medical K020895 Allomatrix Technologies 4. Comparison to the Predicate Device(s): OpteCure is the substantially equi… | 2004 |
What descends from it? (3)
2 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 7 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K061668 (Exactech, Inc., 2006) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K040755.
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?
OpteCure is intended for use as a bone graft extender (extremities, spine and pelvis) and as a bone void filler (extremities and pelvis) for bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
OpteCure may be used with rigid fixation systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050806 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050806: Optecure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050806
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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