# K180758: Osteocera Resorbable Bone Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Wiltrom Corporation Limited
- Decided: Oct 24, 2018 after 216 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: 1 generation back to K043045 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043045: Synthes (Usa) Chronos, Synthes (Usa) (2005) Summary page 4.

## Indications for use
Osteocera Resorbable Bone Substitute is intended for use as a bone void filler for voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis) that are not intrinsic to the stability of the bony structure. Osteocera Resorbable Bone Substitute is indicated for use in the treatment of osseous defects created surgically or through traumatic injury. Following placement into the bony void, Osteocera Resorbable Bone Substitute resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K180758
Methodology: https://510kreport.com/methodology