510(k) · Cleared
ClearedVertebral Access System by Vidacare
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vidacare Corporation · MOQ Battery, Replacement, Rechargeable
Cleared on Nov 21, 2008 as substantially equivalent to K072045 (Vidacare Corporation, 2007) and 1 other predicate after a 157-day review. Its family tree reaches back 5 generations to 1989. 1 of the 20 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Nov 21, 2008
- Review
- 157 days
- Class
- Class I
- Product code
- MOQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K890925 (1989). 15 ancestors in all. 4 later devices descend from it, 1 citing it directly. 1 of the 20 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK890925 Manan Bone Marrow Biopsy NeedleManan Medical Products, Inc. · 1989 · Recalled
- 4 generations backK961959 MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1996
- 3 generations backK980196 MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1998 · Recalled (Class I)
- 2 generations backK043523 Interv Brand Snarelok Bone Marrow Biopsy NeedleMedical Device Technologies, Inc. · 2005
- 1 generation backK072045 Oncontrol Bone Marrow Biopsy SystemVidacare Corporation · 2007
- This deviceK081713 Vertebral Access System by VidacareVidacare Corporation · 2008
- Descendant · cites it directly · 3 of its ownK112468 The Oncontrol Bone Access System by VidacareRegulatory Specialists, Inc. · 2011
- Descendant · 2 generations on · 2 of its ownK113872 The Oncontrol Bone Access and Bone Biopsy System by VidacareVidacare Corporation · 2012 · Recalled
- Descendant · 3 generations on · 0 of its ownK230015 OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone…Laurane Medical Sas · 2023
- Descendant · 3 generations on · 0 of its ownK213896 BD Trek Powered Bone Biopsy SystemBard Peripheral Vascular · 2022
Class I recalls in this family
- K980196 MD Tech Biopsy Set for Bone and Bone Marrow3 generations back · 1998
Most influential descendants
Showing 4 of 4 · See all- K112468The Oncontrol Bone Access System by VidacareRegulatory Specialists, Inc. · 2011 · cites it directly3descendants
- K113872The Oncontrol Bone Access and Bone Biopsy System by VidacareVidacare Corporation · 2012 · 2 generations on2descendants
- K230015OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power…Laurane Medical Sas · 2023 · 3 generations on0descendants
- K213896BD Trek Powered Bone Biopsy SystemBard Peripheral Vascular · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K890925 | Manan Bone Marrow Biopsy Needle | Manan Medical Products, Inc. | 1989 | 7 |
| −4 | K961959 | MD Tech Biopsy Set for Bone and Bone Marrow | Medical Device Technologies, Inc. | 1996 | — |
| −3 | K980196 | MD Tech Biopsy Set for Bone and Bone Marrow | Medical Device Technologies, Inc. | 1998 | Class I |
| −2 | K043523 | Interv Brand Snarelok Bone Marrow Biopsy Needle | Medical Device Technologies, Inc. | 2005 | — |
| −1 | K072045 | Oncontrol Bone Marrow Biopsy System | Vidacare Corporation | 2007 | — |
| 0 (this device) | K081713 | Vertebral Access System by Vidacare | Vidacare Corporation | 2008 | — |
| +1 | K112468 | The Oncontrol Bone Access System by Vidacare | Regulatory Specialists, Inc. | 2011 | — |
| +2 | K113872 | The Oncontrol Bone Access and Bone Biopsy System by Vidacare | Vidacare Corporation | 2012 | 2 |
| +3 | K230015 | OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit… | Laurane Medical Sas | 2023 | — |
| +3 | K213896 | BD Trek Powered Bone Biopsy System | Bard Peripheral Vascular | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K072045 | Oncontrol Bone Marrow Biopsy SystemSummary page 2…K081713 Vidacare Addendum 3 The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]: -510(k) Number K072045 1 K07245 1'11System EZ-IO® Trade or Proprietary o… | 2007 |
| * | K051820 | Parallax Ezflow Cement Delivery SystemSummary page 2…rer Vdcr op 1Vdcr op K051820 Parallax EZFlow Cement Delivery Parallax 12K518 12 System 121 Me… | 2005 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112468 | The Oncontrol Bone Access System by Vidacare | 2011 | 3 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K980196MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1998 · 3 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 15 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K112468 (Regulatory Specialists, Inc., 2011) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K072045.
How does its category compare?
All MOQ devicesMOQ Battery, Replacement, Rechargeable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MOQ
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · MOQ
Too few MOQ 510(k)s in any year since 2007 to give a median.
Recalls per year · MOQ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOQ
193in 2025
MAUDE reports naming product code MOQ, 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 | 0 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 8 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 202 |
| 2014 | 0 | — | 0 | 526 |
| 2015 | 0 | — | 0 | 769 |
| 2016 | 0 | — | 0 | 364 |
| 2017 | 0 | — | 0 | 507 |
| 2018 | 0 | — | 0 | 133 |
| 2019 | 0 | — | 0 | 78 |
| 2020 | 0 | — | 0 | 120 |
| 2021 | 0 | — | 0 | 123 |
| 2022 | 0 | — | 0 | 860 |
| 2023 | 0 | — | 0 | 125 |
| 2024 | 0 | — | 1 | 184 |
| 2025 | 0 | — | 0 | 193 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Vertebral Access System by Vidacare® is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty. This system does not contain cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081713 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081713: Vertebral Access System by Vidacare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081713
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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