# K011726: Millenium's Skelite Synthetic Resorbable Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Millenium Biologix, Inc.
- Decided: May 16, 2002 after 346 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
No predicates in its family tree.
114 later devices descend from it; 1 cites it directly.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K040082: Pore-SI Bone Graft Substitute (2004), 113 descendants of its own
- K071206: Actifuse Abx E-Z-Fil Putty Bone Graft Substitute (2007), 111 descendants of its own
- K080736: Actifuse Shape Bone Graft Substitute (2008), 79 descendants of its own
- K151584: AttraX Putty (2015), 76 descendants of its own
- K191974: NuVasive AttraX Putty (2019), 71 descendants of its own

## Indications for use
The Skelite™ Synthetic Resorbable Bone Void Filler is indicated only for bony voids or gaps that are not intringic to the stability of the bony structure. Skelite M is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. The product can be mixed with bone marrow.

Source page: https://510kreport.com/device/K011726
Methodology: https://510kreport.com/methodology