510(k) · Cleared
ClearedArthrocare Parallax Contour Vertebral Augmentation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrocare Corp. · NDN Cement, Bone, Vertebroplasty
Cleared on Feb 16, 2011 as substantially equivalent to K100479 (Arthrocare Corp., 2010) after a 26-day review. Its family tree reaches back 8 generations to 2001.
- Decided
- Feb 16, 2011
- Review
- 26 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K002652 (2001). 18 ancestors in all, the oldest K890925 (1989). No later device cites it as a predicate yet.
- Root · 8 generations backK002652 Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp. · 2001 · Recalled
- 7 generations backK033801 Kyphx HV-R, Model C01AKyphon, Inc. · 2004 · Recalled
- 6 generations backK041584 Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · Recalled
- 5 generations backK042415 Mendec SpineTecres S.P.A. · 2005
- 4 generations backK062452 Kit Mendec Spine and Delivery SystemTecres S.P.A. · 2006
- 3 generations backK063248 Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek · 2007
- 2 generations backK072133 Avaflex Vertebral Augmentation NeedleCardinal Health, Inc. · 2007
- 1 generation backK100479 Parallax Contour Vertebral Augmentation DeviceArthrocare Corp. · 2010
- This deviceK110183 Arthrocare Parallax Contour Vertebral Augmentation DeviceArthrocare Corp. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K002652 | Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii | Stryker Corp. | 2001 | 1 |
| −7 | K033801 | Kyphx HV-R, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −6 | K041584 | Kyphx HV-R Bone Cement, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −5 | K042415 | Mendec Spine | Tecres S.P.A. | 2005 | — |
| −4 | K062452 | Kit Mendec Spine and Delivery System | Tecres S.P.A. | 2006 | — |
| −3 | K063248 | Arcuate Vertebral Augmentation System | Medtronic Sofamor Danek | 2007 | — |
| −2 | K072133 | Avaflex Vertebral Augmentation Needle | Cardinal Health, Inc. | 2007 | — |
| −1 | K100479 | Parallax Contour Vertebral Augmentation Device | Arthrocare Corp. | 2010 | — |
| 0 (this device) | K110183 | Arthrocare Parallax Contour Vertebral Augmentation Device | Arthrocare Corp. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 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? (1)
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 |
|---|---|---|---|
| * | K100479 | Parallax Contour Vertebral Augmentation DeviceSummary page 1…Class I Orthopedic Manual Instrument (Section 878.4540) Predicate Device: ArthroCare Parallax Contour K100479 (cleared September 21, 20 10) Vertebral Augmentation Device Product Description The ArthroCare Parallax Contour Vertebral Augme… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 10 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 5 of the 18 ancestors have a recall of any class.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 ArthroCare® Parallax® Contour® Vertebral Augmentation Device - enhanced when used with the access needle kits are indicated for use during kyphoplasty or vertebral augmentation procedures to create a void in the vertebral body and fill the void with Parallax® Acrylic Resin (bone cement). The painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110183 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110183: Arthrocare Parallax Contour Vertebral Augmentation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110183
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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