# K133678: Confirm Bioactive

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Aug 26, 2014 after 270 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.
No later device cites it as a predicate yet.
0 of 57 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) Summary page 5.
- K103173: Vitoss BA Bimodal Bioactive Bone Graft Substitute, Orthovita, Inc. (2011) Summary page 5.
- K994337: Vitoss Scaffold Synthetic Cancellous Bone Void Filler, Orthovita Co. (2000) Summary page 5.
- K080009: Novabone Putty- Bioactive Synthetic Graft, Novabone Products, LLC (2008) Summary page 5.

## Indications for use
CONFIRM™ 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. CONFIRM™ Crunch is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine) and must be combined with bone marrow aspirate and autogenous bone graft. CONFIRM™ Putty, Plus Putty, Gel, Plus Gel, and Plus Crunch are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis) and must be combined with bone marrow aspirate and autogenous bone graft. CONFIRM™ resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K133678
Methodology: https://510kreport.com/methodology