# K050642: Orthoblast II Putty and Paste

- Pathway: 510(k) (Traditional)
- Applicant: Isotis Orthobiologics, Inc.
- Decided: Dec 5, 2005 after 269 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: 2 generations back to K040980 (2004). 3 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 12 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). Our reading of the summary gave K040416, FDA’s number for Sonicare Advance Toothbrush, Model 4900 (Philips Oral Healthcare, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “DynaGraft II Putty and Gel”.

## Most influential descendants
- K091193: Accell EVO3C (2009), 2 descendants of its own
- K061668: Optecure +CCC (2006), 2 descendants of its own
- K212135: Dry DBM- A Putty (2021), 1 descendant 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
- K070751: Orthoblast II DBM Demineralized Bone Matrix Paste and Putty (2007), 1 descendant of its own

## Indications for use
OrthoBlast® II is an osteoinductive and osteoconductive bone filling material indicated: OrthoBlast® I is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. OrthoBlast® II is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender and as a bone 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/K050642
Methodology: https://510kreport.com/methodology