510(k) · Cleared
ClearedOptecure +CCC
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 Sep 12, 2006 as substantially equivalent to K050806 (Exactech, Inc., 2006) and 4 other predicates after a 90-day review. Its family tree reaches back 5 generations to 1999. 2 later devices descend from it.
- Decided
- Sep 12, 2006
- Review
- 90 days
- Class
- Class II
- Product code
- MBP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K990131 (1999). 20 ancestors in all, the oldest K963562 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 4 generations backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
- 3 generations backK032268 MBCPBiomatlante · 2003
- 2 generations backK043005 Modification to MBCPBiomatlante · 2005
- 1 generation backK050806 OptecureExactech, Inc. · 2006
- This deviceK061668 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute | Interpore Cross Intl. | 1999 | — |
| −4 | K020986 | Mastergraft Resorbable Ceramic | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −3 | K032268 | MBCP | Biomatlante | 2003 | — |
| −2 | K043005 | Modification to MBCP | Biomatlante | 2005 | — |
| −1 | K050806 | Optecure | Exactech, Inc. | 2006 | — |
| 0 (this device) | 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 | 4 | 0 |
| 2005 | 7 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K050806 | OptecureSummary page 2…Manufhcturer 510k)Numuber Product Code MQV, MBP Exacteeb Inc. K050806 OptecureTM MQV Regeneration K043421… | 2006 |
| * | K043421 | Opteform, Osteofil, Rti Allograft Paste IC, Rti Allograft Strip ICSummary page 2…MQV, MBP Exacteeb Inc. K050806 OptecureTM MQV Regeneration K043421 Optefornm®R Technologies MQV, MB1~ Osteotech… | 2005 |
| * | K051195 | Grafton DBMSummary page 2…K043421 Optefornm®R Technologies MQV, MB1~ Osteotech K051 195 Grafton(X& DBM MQV, MBP IsoTis K050642… | 2005 |
| * | K050642 | Orthoblast II Putty and PasteSummary page 2…, MB1~ Osteotech K051 195 Grafton(X& DBM MQV, MBP IsoTis K050642 OrthoBlastS IL MQV, MBP Muskuloskeletal K040262… | 2005 |
| * | K040262 | DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix MixSummary page 2…, MBP IsoTis K050642 OrthoBlastS IL MQV, MBP Muskuloskeletal K040262 DBXt& Demineralized Bone Tissue… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121989 | Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone… | 2012 | 1 |
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.
- 5 of the 20 ancestors have a recall of any class.
- Of its descendants, K121989 (Exactech, Inc., 2012) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K050806.
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 + CCC 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/K061668 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061668: Optecure +CCC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061668
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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