# K040082: Pore-SI Bone Graft Substitute

- Pathway: 510(k) (Abbreviated)
- Applicant: Apatech, Ltd.
- Decided: Aug 4, 2004 after 202 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 K960978 (1996). 6 ancestors in all.
113 later devices descend from it; 3 cite it directly.
0 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030131: Ossatura BCP Bone Void Filler, Isotis NV (2003) Summary page 1.
- K011726: Millenium's Skelite Synthetic Resorbable Bone Void Filler, Millenium Biologix, Inc. (2002) Summary page 1.

## Most influential descendants
- 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
- K203714: NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty (2021), 66 descendants of its own

## Indications for use
Pore-Si is a bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Pore-Si is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e. extremities, spine and pelvis. These defects may be surgically created osseous defect or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Source page: https://510kreport.com/device/K040082
Methodology: https://510kreport.com/methodology