# K110949: Bicera (TM) Resorbable Bone Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Wiltrom Corporation Limited
- Decided: Sep 18, 2012 after 533 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: 3 generations back to K990131 (1999). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032268: MBCP, Biomatlante (2003) Summary page 2.

## Most influential descendants
- K171629: ABCcolla Bone Graft (2018), 1 descendant of its own
- K212156: ABCcolla Bone Matrix (2021), 0 descendants of its own
- K172237: Bicera Resorbable Bone Substitute (2018), 0 descendants of its own

## Indications for use
BiceraTM Resorbable Bone Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. BiceraTM Resorbable Bone Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. BiceraTM Resorbable Bone Substitute is intended to be packed into bony voids or gaps of the skeletal system as a bone void filler (i.e., extremities and pelvis). This product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Source page: https://510kreport.com/device/K110949
Methodology: https://510kreport.com/methodology