# K050806: Optecure

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Feb 8, 2006 after 315 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: 4 generations back to K990131 (1999). 12 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040755: Exactech Resorbable Room Temperature Bone Paste, Exactech, Inc. (2004) Summary page 2.
- K043420: Osteofil, Optefil, Regenafil, Rti Allograft Paste, Regeneration Technologies, Inc. (2005) Summary page 2.
- K043005: Modification to MBCP, Biomatlante (2005). Cleared while this submission was under review Summary page 2.
- K020895: Allomatrix Model# 86, Wrightmedicaltechnologyinc (2004) Summary page 2.

## Most influential descendants
- K061668: Optecure +CCC (2006), 2 descendants of its own
- 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 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/K050806
Methodology: https://510kreport.com/methodology