# K130977: Signify Bioactive

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Dec 24, 2013 after 259 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: 11 generations back to K960978 (1996). 56 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130392: Kinex Bioactive, Globus Medical, Inc. (2013). Cleared while this submission was under review 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.

## Cited in the summary but kept off the family tree
- K110317: Vitoss BA Bioactive Bone Graft Substitute. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Most influential descendants
- K221737: InstaFill Graft Delivery System, SIGNIFY Bioactive (2022), 0 descendants of its own

## Indications for use
SIGNIFY Bioactive is intended for use as a bone void filler 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. SIGNIFY Crunch is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine). SIGNIFY Putty and Gel are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). SIGNIFY resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K130977
Methodology: https://510kreport.com/methodology