# K042168: CONCORD Radiopaque Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jan 14, 2005 after 158 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: 2 generations back to K002652 (2001). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033801: Kyphx HV-R, Model C01A, Kyphon, Inc. (2004) Summary page 1.
- K032945: Simplex X, Stryker Corp. (2004) Summary page 1.

## Cited in the summary but kept off the family tree
- K017004: Howmedica Osteonics Surgical Simplex® P Radiopaque Bone Cement. 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 Summary page 2.

## Most influential descendants
- K162618: CONCORD Plus Radiopaque Bone Cement (2017), 5 descendants of its own
- 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

## Indications for use
Symphony TM VR 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/K042168
Methodology: https://510kreport.com/methodology