510(k) · Cleared
ClearedCONCORD 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 14, 2005 as substantially equivalent to K033801 (Kyphon, Inc., 2004) and 1 other predicate after a 158-day review. Its family tree reaches back 2 generations to 2001. 6 later devices descend from it.
- Decided
- Jan 14, 2005
- Review
- 158 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K002652 (2001). 3 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK002652 Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp. · 2001 · Recalled
- 1 generation backK033801 Kyphx HV-R, Model C01AKyphon, Inc. · 2004 · Recalled
- This deviceK042168 CONCORD Radiopaque Bone CementGlobus Medical, Inc. · 2005
- Descendant · cites it directly · 5 of its ownK162618 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K162618CONCORD Plus Radiopaque Bone CementGlobus Medical, Inc. · 2017 · cites it directly5descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002652 | Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii | Stryker Corp. | 2001 | 1 |
| −1 | K033801 | Kyphx HV-R, Model C01A | Kyphon, Inc. | 2004 | 2 |
| 0 (this device) | K042168 | CONCORD Radiopaque Bone Cement | Globus Medical, Inc. | 2005 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033801 | Kyphx HV-R, Model C01ASummary page 1…monomer, which includes hydroquinone as the stabilizer and N:N dimethyl-p-toluidine as the activator. Predicate Devices: K033801: Kyphon Inc. - KyphX® HV-R Bone Cement K032945: Stryker SpineplexTM Radiopaque… | 2004 |
| * | K032945 | Simplex XSummary page 1…nd N:N dimethyl-p-toluidine as the activator. Predicate Devices: K033801: Kyphon Inc. - KyphX® HV-R Bone Cement K032945: Stryker SpineplexTM Radiopaque Bone Cement CONFIDENTIAL… | 2004 |
| 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…== Page 2 === 510(k) Premarket Notification Advanced Biomaterial Systems, Inc. N017004: Howmedica Osteonics Surgical Simplex® P Radiopaque Bone Cement Intended Use:… |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K162618 (Globus Medical, Inc., 2017) has gone furthest, with 5 descendants of its own.
- 5 other devices also cite its predicate K033801.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042168: CONCORD 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/K042168
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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