510(k) · Cleared
ClearedModification to Vertebroplastic Radiopaque Bone Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Spine, A Johnson & Johnson Company · NDN Cement, Bone, Vertebroplasty
Cleared on Nov 21, 2007 as substantially equivalent to K043406 (Depuy Spine, Inc., 2005) and 1 other predicate after a 132-day review. Its family tree reaches back 4 generations to 2001. 2 later devices descend from it.
- Decided
- Nov 21, 2007
- Review
- 132 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K002652 (2001). 10 ancestors in all, the oldest K873689 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK002652 Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp. · 2001 · Recalled
- 3 generations backK033801 Kyphx HV-R, Model C01AKyphon, Inc. · 2004 · Recalled
- 2 generations backK041584 Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · Recalled
- 1 generation backK043406 Vertebroplastic Radiopaque Bone CementDepuy Spine, Inc. · 2005
- This deviceK071927 Modification to Vertebroplastic Radiopaque Bone CementDepuy Spine, A Johnson & Johnson Company · 2007
- Descendant · cites it directly · 0 of its ownK201831 CONFIDENCE Spinal Cement SystemDepuy Spine, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK112907 Confidence High Viscosity Spinal Cement, 16G / 20GMedos International SARL · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002652 | Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii | Stryker Corp. | 2001 | 1 |
| −3 | K033801 | Kyphx HV-R, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −2 | K041584 | Kyphx HV-R Bone Cement, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −1 | K043406 | Vertebroplastic Radiopaque Bone Cement | Depuy Spine, Inc. | 2005 | — |
| 0 (this device) | K071927 | Modification to Vertebroplastic Radiopaque Bone Cement | Depuy Spine, A Johnson & Johnson Company | 2007 | — |
| +1 | K201831 | CONFIDENCE Spinal Cement System | Depuy Spine, Inc. | 2020 | — |
| +1 | K112907 | Confidence High Viscosity Spinal Cement, 16G / 20G | Medos International SARL | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1997 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2020 | 1 | 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 |
|---|---|---|---|
| * | K043406 | Vertebroplastic Radiopaque Bone CementSummary page 1…NDN SUBSTANTIALLY EQUIVALENT T Vertebroplastic M Radiopaque Bone Cement (K043406) DEVICES: SmartSet GMV Endurance Gentamicin Bone Cement… | 2005 |
| * | K033382 | Smartset GMV Endurance Gentamicin Bone CementSummary page 1…Radiopaque Bone Cement (K043406) DEVICES: SmartSet GMV Endurance Gentamicin Bone Cement (K033382). DEVICE DESCRIPTION: VertebroplasticTM Radiopaque Bone Cement is a self-curing, radiopaque, polymethylmethacrylate (PMMA) ceme… | 2004 |
What descends from it? (2)
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 6 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 5 of the 10 ancestors have a recall of any class.
- Of its descendants, K201831 (Depuy Spine, Inc., 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The VertebroplasticTM Radiopaque Bone Cement is indicated for the treatment, using vertebroplasty or kyphoplasty procedures, of pathological fractures of the vertebral body caused by osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, mycloma).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071927 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071927: Modification to Vertebroplastic 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/K071927
Report an extraction error
Are you the manufacturer?
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