# K060011: Miig SR

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Feb 27, 2006 after 55 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.
16 later devices descend from it; 2 cite it directly.
0 of 17 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) Wright Medical Technology bone void fillers: named in the summary without a submission number

## Most influential descendants
- K070437: Pro-Dense Bone Void Filler (2007), 15 descendants of its own
- K113871: Pro-Dense Bone Graft Substitute (2013), 11 descendants of its own
- K072597: Pro-Dense Core Decompression Procedure Kit (2007), 10 descendants of its own
- K181255: PRODENSE Bone Graft Substitute (2018), 7 descendants of its own
- K182823: PRODENSE Bone Graft Substitute (2018), 5 descendants of its own

## Indications for use
The intended use for the MIIG® SR resultant paste is to be injected, digitally packed into open bone voids/gaps to cure in-situ, or molded into solid pellets that are gently packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities, spine, and pelvis). These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste/pellets provide a bone void filler that resorbs and is replaced with bone during the healing process. The MIIG® SR paste cured in situ provides an open void/gap 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 provide structural support during the healing process. MIIG® SR is provided sterile for single use only.

Source page: https://510kreport.com/device/K060011
Methodology: https://510kreport.com/methodology