# K091193: Accell EVO3C

- Pathway: 510(k) (Traditional)
- Applicant: Isotis Orthobiologics, Inc.
- Decided: Aug 10, 2009 after 109 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K040980 (2004). 8 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K061880: Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC, Isotis NV (2007) Summary page 1.
- K040419: Dynagraft II, Isotis Orthobiologics, Inc. (2005) Summary page 1.
- K050642: Orthoblast II Putty and Paste, Isotis Orthobiologics, Inc. (2005) Summary page 1.
- K063676: DBX Demineralized Bone Matrix Mix, Musculoskeletal Transplant Foundation (2007) Summary page 1.
- K051195: Grafton DBM, Osteotech, Inc. (2005) Summary page 1.

## Most influential descendants
- K212135: Dry DBM- A Putty (2021), 1 descendant of its own
- K231030: Cove Putty, OsteoCove Putty (2023), 0 descendants of its own

## Recalls of this device
- May 19, 2014 · Class II · Z-1868-2014: This lot of Accell Evo3C Demineralized Bone Matrix, 5cc was incorrectly packaged in boxes that describe the product as Accell Evo3 Demineralized Bone Matrix. Evo3C is contraindicated for treatment of 

## Indications for use
Accell Evo3c TM is intended for filling voids and gaps in.the skeletal system that are not intrinsic to the stability of the bony structure. Accell Evo3c is indicated for use as a bone graft extender in the posterolateral spine, extremities and pelvis, or as a bone void filler in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.

Source page: https://510kreport.com/device/K091193
Methodology: https://510kreport.com/methodology