# K121989: Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone Void Filler (1CC, 2CC, 5CC, 10CC,

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Nov 27, 2012 after 144 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- 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: 6 generations back to K990131 (1999). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 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 1.
- K061668: Optecure +CCC, Exactech, Inc. (2006) Summary page 1.
- K110003: MTF New Bone Void Filler, Musculoskeletal Transplant Foundation (2011) Summary page 1.
- K113167: MTF New Bone Voild Filler, Musculoskeletal Transplant Foundation (2012) Summary page 1.
- K053218: DBX Demineralized Bone Matrix Putty/Paste/Mix, Musculoskeletal Transplant Foundation (2006) Summary page 1.
- K063676: DBX Demineralized Bone Matrix Mix, Musculoskeletal Transplant Foundation (2007) Summary page 1.
- K080399: DBX Demineralized Bone Matrix Putty, DBX Demineralized Bone Matrix Paste, Musculoskeletal Transplant Foundation (2008) Summary page 1.
- K103784: DBX Demineralized Bone Matrix Putty, Musculoskeletal Transplant Foundation (2011) Summary page 1.
- K103795: DBX Demineralized Bone Matrix Putty, Musculoskeletal Transplant Foundation (2011) Summary page 1.

## Most influential descendants
- K241555: Moldable Bone Void Filler and Moldable Bone Void Filler + CCC (2025), 0 descendants of its own

## Indications for use
Optecure and Optecure +CCC are intended for use in combination with autogenous bone as a bone graft extender (extremities, spine and pelvis) and as bone void fillers (extremities and pelvis) for bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. Optecure and Optecure + CCC can be used with autogenous bone marrow. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Optecure and Optecure ±CCC may be used with rigid fixation systems.

Source page: https://510kreport.com/device/K121989
Methodology: https://510kreport.com/methodology