# K052098: Connexus, .5CC, Model 023000-005

- Pathway: 510(k) (Special)
- Applicant: Isotis Orthobiologics, Inc.
- Decided: Sep 7, 2005 after 35 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: 3 generations back to K040980 (2004). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050690: Connexus, Isotis Orthobiologics, Inc. (2005) Summary page 1.

## Indications for use
Connexus is an osteoinductive and osteoconductive bone filling material indicated: For orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. Connexus is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender and as bony void filler of the extremities and pelvis. These defects may be surgically created or from the result of traumatic injury to the bone.

Source page: https://510kreport.com/device/K052098
Methodology: https://510kreport.com/methodology