# K061880: Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC

- Pathway: 510(k) (Traditional)
- Applicant: Isotis NV
- Decided: Aug 15, 2007 after 408 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.
5 later devices descend from it; 3 cite it directly.
0 of 10 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) 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
- K091193: Accell EVO3C (2009), 2 descendants of its own
- K212135: Dry DBM- A Putty (2021), 1 descendant of its own
- K231030: Cove Putty, OsteoCove Putty (2023), 0 descendants of its own
- K103742: Accell EVO3 (Formerly Accell A2I) (2011), 0 descendants of its own
- K081817: Accell TBM-R (2008), 0 descendants of its own

## Indications for use
The Accell Family of products are intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The products are indicated for use as bone graft extenders in the spine, extremities and pelvis, or as bone void fillers 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/K061880
Methodology: https://510kreport.com/methodology