# K132470: Solum IV Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Spinesmith Partners, Llp
- Decided: May 21, 2014 after 287 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: 5 generations back to K960978 (1996). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081558: Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CC, Pioneer Surgical Technology (2008) Summary page 1.

## Indications for use
Solum IV ® is intended for bony, voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (i.e., extremities and pelvis) in conjunction with anl equal volume of bone marrow aspirate. These dclbcts may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void Filler that resorbs and is replaced by the growth of new bone during the healing process.

Source page: https://510kreport.com/device/K132470
Methodology: https://510kreport.com/methodology