510(k) · Cleared
ClearedCONCORD Plus Radiopaque Bone Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · NDN Cement, Bone, Vertebroplasty
Cleared on Jan 23, 2017 as substantially equivalent to K042168 (Globus Medical, Inc., 2005) and 1 other predicate after a 125-day review. Its family tree reaches back 3 generations to 2001. 5 later devices descend from it.
- Decided
- Jan 23, 2017
- Review
- 125 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002652 (2001). 6 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK002652 Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp. · 2001 · Recalled
- 2 generations backK033801 Kyphx HV-R, Model C01AKyphon, Inc. · 2004 · Recalled
- 1 generation backK042168 CONCORD Radiopaque Bone CementGlobus Medical, Inc. · 2005
- This deviceK162618 CONCORD Plus Radiopaque Bone CementGlobus Medical, Inc. · 2017
- Descendant · cites it directly · 4 of its ownK172269 FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™)…Globus Medical, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK181068 CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK253943 Tiger 2 SystemZavation Medical Products, LLC · 2026
- Descendant · 3 generations on · 0 of its ownK253739 SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization…Globus Medical, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK213196 MARVEL™ Growing RodsGlobus Medical, Inc. · 2022
Most influential descendants
Showing 5 of 5 · See all- K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc. · 2018 · cites it directly4descendants
- K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc. · 2018 · 2 generations on2descendants
- K253943Tiger 2 SystemZavation Medical Products, LLC · 2026 · 2 generations on0descendants
- K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc. · 2026 · 3 generations on0descendants
- K213196MARVEL™ Growing RodsGlobus Medical, Inc. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002652 | Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii | Stryker Corp. | 2001 | 1 |
| −2 | K033801 | Kyphx HV-R, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −1 | K042168 | CONCORD Radiopaque Bone Cement | Globus Medical, Inc. | 2005 | — |
| 0 (this device) | K162618 | CONCORD Plus Radiopaque Bone Cement | Globus Medical, Inc. | 2017 | — |
| +1 | K172269 | FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO®… | Globus Medical, Inc. | 2018 | — |
| +2 | K181068 | CREO® Stabilization System, REVERE® Stabilization System | Globus Medical, Inc. | 2018 | — |
| +2 | K253943 | Tiger 2 System | Zavation Medical Products, LLC | 2026 | — |
| +3 | K253739 | SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System… | Globus Medical, Inc. | 2026 | — |
| +3 | K213196 | MARVEL™ Growing Rods | Globus Medical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2022 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NDN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NDN device
- #1 K241775 XeliteMed VertehighFix High Viscosity Spinal…score 14.9 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042168 | CONCORD Radiopaque Bone CementSummary page 4…Product Code: NDN Regulatory Class: II, Panel Code: Orthopedic 87 Predicate(s): Primary CONCORD™ Radiopaque Bone Cement (K042168) Additional VertaPlex® HV Radiopaque Bone Cement (K091606) Purpose: The purpose of this submission is to request cleara… | 2005 |
| * | K091606 | Vertaplex HV (Single Pack and Dual Pack)Summary page 4…ass: II, Panel Code: Orthopedic 87 Predicate(s): Primary CONCORD™ Radiopaque Bone Cement (K042168) Additional VertaPlex® HV Radiopaque Bone Cement (K091606) Purpose: The purpose of this submission is to request clearance of the CONCORD Plus™ Radiopaque Bone Cement. DEVICE DESCRIPTIO… | 2009 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172269 | FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw… | 2018 | 4 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K172269 (Globus Medical, Inc., 2018) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K042168.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · NDN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NDN
90in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NDN
4in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDN
626in 2025
MAUDE reports naming product code NDN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 128 | 0 | 21 |
| 2008 | 1 | — | 0 | 39 |
| 2009 | 6 | 211 | 1 | 70 |
| 2010 | 5 | 215 | 0 | 396 |
| 2011 | 11 | 164 | 0 | 98 |
| 2012 | 7 | 90 | 0 | 89 |
| 2013 | 7 | 118 | 4 | 242 |
| 2014 | 7 | 106 | 0 | 231 |
| 2015 | 6 | 76 | 0 | 204 |
| 2016 | 4 | 154 | 0 | 182 |
| 2017 | 5 | 125 | 0 | 191 |
| 2018 | 3 | 111 | 0 | 144 |
| 2019 | 2 | — | 0 | 227 |
| 2020 | 4 | 157 | 0 | 212 |
| 2021 | 2 | — | 0 | 344 |
| 2022 | 2 | — | 0 | 270 |
| 2023 | 2 | — | 0 | 311 |
| 2024 | 3 | 90 | 0 | 454 |
| 2025 | 2 | — | 0 | 626 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162618 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162618: CONCORD Plus Radiopaque Bone Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162618
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026