# K162618: CONCORD Plus Radiopaque Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jan 23, 2017 after 125 days
- Product code: NDN (Cement, Bone, Vertebroplasty)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002652 (2001). 6 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042168: CONCORD Radiopaque Bone Cement, Globus Medical, Inc. (2005) Summary page 4.
- K091606: Vertaplex HV (Single Pack and Dual Pack), Stryker Corp. (2009) Summary page 4.

## Most influential descendants
- K172269: FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System (2018), 4 descendants of its own
- K181068: CREO® Stabilization System, REVERE® Stabilization System (2018), 2 descendants of its own
- K253943: Tiger 2 System (2026), 0 descendants of its own
- K253739: SCRIPT™ Rods, CREO™ Stabilization System,  REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System (2026), 0 descendants of its own
- K213196: MARVEL™ Growing Rods (2022), 0 descendants of its own

## Indications for use
CONCORD Plus™ Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Source page: https://510kreport.com/device/K162618
Methodology: https://510kreport.com/methodology