# K103742: Accell EVO3 (Formerly Accell A2I)

- Pathway: 510(k) (Traditional)
- Applicant: Integra Life Sciences
- Decided: Mar 17, 2011 after 84 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: 3 generations back to K040980 (2004). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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.
- K051195: Grafton DBM, Osteotech, Inc. (2005) Summary page 1.

## Indications for use
Accell Evo3 is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use as a bone graft extender in the spine, extremities and pelvis. Accell Evo3 may also be used as. a bone void filler in the posterolateral spine, 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/K103742
Methodology: https://510kreport.com/methodology