# K130392: Kinex Bioactive

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Aug 15, 2013 after 181 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: 10 generations back to K960978 (1996). 55 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103173: Vitoss BA Bimodal Bioactive Bone Graft Substitute, Orthovita, Inc. (2011) Summary page 1.
- K994337: Vitoss Scaffold Synthetic Cancellous Bone Void Filler, Orthovita Co. (2000) Summary page 1.
- K080009: Novabone Putty- Bioactive Synthetic Graft, Novabone Products, LLC (2008) Summary page 1.
- K103799: Inqu Paste Mix Plus, Isto Technologies, Inc. (2011) Summary page 1.

## Most influential descendants
- K173008: SCS 17-01 (2017), 4 descendants of its own
- K190956: SCS 17-01 (2020), 3 descendants of its own
- K212083: Tactoset Injectable Bone Substitute (2021), 2 descendants of its own
- K223915: Tactoset (2023), 1 descendant of its own
- K130977: Signify Bioactive (2013), 1 descendant of its own

## Indications for use
KINEXTM Bioactive is intended for use as a bone void filler and autograft extender for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from traumatic injury to the bone. KINEXTM Plus Putty and KINEXTM Plus Gel are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and spine) and should be combined with bone marrow aspirate. KINEX TM Strip, KINEX TM Plus Strip, KINEX TM Putty and KINEX TM Gel are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis) and should be combined with bone marrow aspirate. KINEXTM resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K130392
Methodology: https://510kreport.com/methodology