# K024336: Miig II Bone Graft Substitute

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Mar 4, 2003 after 67 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.
47 later devices descend from it; 7 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MIIG: named in the summary without a submission number

## Most influential descendants
- K060061: Stryker Injectable Cement (2006), 30 descendants of its own
- K161447: HydroSet XT (2016), 10 descendants of its own
- K051951: Cerament Bone Void Filler (2005), 10 descendants of its own
- K060763: Stryker Injectable Cement (2006), 8 descendants of its own
- K073316: Cerament Bone Void Filler, Model A0210 (2008), 6 descendants of its own

## Indications for use
The MTIGTMpaste is intended to be injected into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system @e., the extremities, spine, and pelvis) and to cure in-situ. These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The MIIGTMpaste provides a bone void filler that resorbs and is replaced with bone during the healing process. The MIIGTMpaste cured in situ provides an open voidgap filler that can augment provisional hardware (e.g., K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provjde structural support during the healing process. The MIIGTMis provided sterile for single use only.

Source page: https://510kreport.com/device/K024336
Methodology: https://510kreport.com/methodology