# K040419: Dynagraft II

- Pathway: 510(k) (Traditional)
- Applicant: Isotis Orthobiologics, Inc.
- Decided: Mar 25, 2005 after 401 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: 1 generation back to K040980 (2004). 2 ancestors in all.
28 later devices descend from it; 8 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040980: Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite Scaffold, Models 860C, 86XC, 86DR, 860D, 860T, Wrightmedicaltechnologyinc (2004). Cleared while this submission was under review Summary page 1.
- K031399: Intergro DBM, Interpore Cross Intl. (2005). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K050642: Orthoblast II Putty and Paste (2005), 8 descendants of its own
- K050690: Connexus (2005), 6 descendants of its own
- K061880: Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC (2007), 5 descendants of its own
- K113728: Surfuse Gel and Putty, Exfuse Gel and Putty (2012), 4 descendants of its own
- K072265: Progenix DMB Putty (2008), 4 descendants of its own

## Indications for use
DynaGraft® II is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. DynaGraft® II is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender (extremities, spine, pelvis) 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/K040419
Methodology: https://510kreport.com/methodology