# K050690: Connexus

- Pathway: 510(k) (Traditional)
- Applicant: Isotis Orthobiologics, Inc.
- Decided: Jul 7, 2005 after 112 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: 2 generations back to K040980 (2004). 4 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040419: Dynagraft II, Isotis Orthobiologics, Inc. (2005). Cleared while this submission was under review Summary page 1.
- K040980: Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite Scaffold, Models 860C, 86XC, 86DR, 860D, 860T, Wrightmedicaltechnologyinc (2004) Summary page 1.
- K031399: Intergro DBM, Interpore Cross Intl. (2005) Summary page 1.
- K043420: Osteofil, Optefil, Regenafil, Rti Allograft Paste, Regeneration Technologies, Inc. (2005) Summary page 1.

## Most influential descendants
- K072265: Progenix DMB Putty (2008), 4 descendants of its own
- K080462: Progenix DBM Putty (2008), 2 descendants of its own
- K081950: Progenix Plus (2008), 1 descendant of its own
- K082002: Progenix Plus (2008), 0 descendants of its own
- K082463: Progenix (2008), 0 descendants of its own

## 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/K050690
Methodology: https://510kreport.com/methodology