510(k) · Cleared
ClearedThe Oncontrol Bone Access System by Vidacare
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Regulatory Specialists, Inc. · KNW Instrument, Biopsy
Cleared on Oct 20, 2011 as substantially equivalent to K081713 (Vidacare Corporation, 2008) and 1 other predicate after a 55-day review. Its family tree reaches back 6 generations to 1989. 1 of the 22 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Oct 20, 2011
- Review
- 55 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K890925 (1989). 18 ancestors in all. 3 later devices descend from it, 1 citing it directly. 1 of the 22 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK890925 Manan Bone Marrow Biopsy NeedleManan Medical Products, Inc. · 1989 · Recalled
- 5 generations backK961959 MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1996
- 4 generations backK980196 MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1998 · Recalled (Class I)
- 3 generations backK043523 Interv Brand Snarelok Bone Marrow Biopsy NeedleMedical Device Technologies, Inc. · 2005
- 2 generations backK072045 Oncontrol Bone Marrow Biopsy SystemVidacare Corporation · 2007
- 1 generation backK081713 Vertebral Access System by VidacareVidacare Corporation · 2008
- This deviceK112468 The Oncontrol Bone Access System by VidacareRegulatory Specialists, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK113872 The Oncontrol Bone Access and Bone Biopsy System by VidacareVidacare Corporation · 2012 · Recalled
- Descendant · 2 generations on · 0 of its ownK230015 OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone…Laurane Medical Sas · 2023
- Descendant · 2 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 Marrow4 generations back · 1998
Most influential descendants
Showing 3 of 3 · See all- K113872The Oncontrol Bone Access and Bone Biopsy System by VidacareVidacare Corporation · 2012 · cites it directly2descendants
- K230015OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power…Laurane Medical Sas · 2023 · 2 generations on0descendants
- K213896BD Trek Powered Bone Biopsy SystemBard Peripheral Vascular · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K890925 | Manan Bone Marrow Biopsy Needle | Manan Medical Products, Inc. | 1989 | 7 |
| −5 | K961959 | MD Tech Biopsy Set for Bone and Bone Marrow | Medical Device Technologies, Inc. | 1996 | — |
| −4 | K980196 | MD Tech Biopsy Set for Bone and Bone Marrow | Medical Device Technologies, Inc. | 1998 | Class I |
| −3 | K043523 | Interv Brand Snarelok Bone Marrow Biopsy Needle | Medical Device Technologies, Inc. | 2005 | — |
| −2 | K072045 | Oncontrol Bone Marrow Biopsy System | Vidacare Corporation | 2007 | — |
| −1 | K081713 | Vertebral Access System by Vidacare | Vidacare Corporation | 2008 | — |
| 0 (this device) | K112468 | The Oncontrol Bone Access System by Vidacare | Regulatory Specialists, Inc. | 2011 | — |
| +1 | K113872 | The Oncontrol Bone Access and Bone Biopsy System by Vidacare | Vidacare Corporation | 2012 | 2 |
| +2 | K230015 | OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit… | Laurane Medical Sas | 2023 | — |
| +2 | 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 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
Top candidate predicates for a new KNW device
- #1 K260572 Marrow Marxmanscore 14.5 · 10 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 |
|---|---|---|---|
| * | K081713 | Vertebral Access System by VidacareSummary page 1…ices to which we are claiming equivalence [807.92(a)(3)]: 51Numbe Trade or Proprietary or Model Name Manufacturer 1K081713 Vertebral Access System by Vidacare® Vidacare Corp 2 K022169 Clearview Plus Bone and Vertebral Bod… | 2008 |
| * | K022169 | Clearview Plus Bone and Vertebral Body Biopsy NeedlesSummary page 1…Trade or Proprietary or Model Name Manufacturer 1K081713 Vertebral Access System by Vidacare® Vidacare Corp 2 K022169 Clearview Plus Bone and Vertebral Body Parallax Medical _______Biopsy Needles Regulat… | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113872 | The Oncontrol Bone Access and Bone Biopsy System by Vidacare | 2012 | 2 |
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 · 4 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 18 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K113872 (Vidacare Corporation, 2012) has gone furthest, with 2 descendants of its own.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KNW
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNW
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNW
1in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · KNW
1,667in 2025
MAUDE reports naming product code KNW, 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 | 6 | 94 | 1 | 766 |
| 2008 | 4 | 53 | 7 | 363 |
| 2009 | 6 | 35 | 3 | 351 |
| 2010 | 3 | 57 | 2 | 162 |
| 2011 | 10 | 64 | 5 | 67 |
| 2012 | 7 | 94 | 1 | 93 |
| 2013 | 3 | 100 | 1 (1) | 98 |
| 2014 | 8 | 95 | 3 | 193 |
| 2015 | 10 | 106 | 0 | 591 |
| 2016 | 9 | 127 | 5 | 297 |
| 2017 | 8 | 90 | 1 | 760 |
| 2018 | 7 | 71 | 0 | 1,012 |
| 2019 | 5 | 94 | 4 | 4,195 |
| 2020 | 8 | 92 | 0 | 5,120 |
| 2021 | 9 | 54 | 3 | 1,020 |
| 2022 | 8 | 203 | 3 | 535 |
| 2023 | 7 | 164 | 2 | 931 |
| 2024 | 5 | 114 | 1 | 1,283 |
| 2025 | 12 | 178 | 0 | 1,667 |
| 2026 | 7 | 29 | 4 (3) | — |
What is it indicated for?
The OnControl Bone 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 and for bone biopsy. This system does not contain cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112468 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112468: The Oncontrol Bone 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/K112468
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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