# K061668: Optecure +CCC

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Sep 12, 2006 after 90 days
- Product code: MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor))
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K990131 (1999). 20 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050806: Optecure, Exactech, Inc. (2006) Summary page 2.
- K043421: Opteform, Osteofil, Rti Allograft Paste IC, Rti Allograft Strip IC, Regeneration Technologies, Inc. (2005) Summary page 2.
- K051195: Grafton DBM, Osteotech, Inc. (2005) Summary page 2.
- K050642: Orthoblast II Putty and Paste, Isotis Orthobiologics, Inc. (2005) Summary page 2.
- K040262: DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix Mix, Musculoskeletal Transplant Foundation (2005) Summary page 2.

## Most influential descendants
- K121989: Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone Void Filler (1CC, 2CC, 5CC, 10CC, (2012), 1 descendant of its own
- K241555: Moldable Bone Void Filler and Moldable Bone Void Filler + CCC (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K061668
Methodology: https://510kreport.com/methodology