510(k) · Cleared

Recalled · Class II · 2021

The Oncontrol Bone Access and Bone Biopsy System by Vidacare

K113872510(k) TraditionalCleared Mar 8, 201269-day reviewClass II21 CFR 876.1075Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vidacare Corporation · KNW Instrument, Biopsy

Cleared on Mar 8, 2012 as substantially equivalent to K112468 (Regulatory Specialists, Inc., 2011) and 2 other predicates after a 69-day review. Its family tree reaches back 7 generations to 1989. 1 of the 23 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 2 times.

Decided: Mar 8, 2012
Review: 69 days
Class: Class II
Product code: KNW
Recalls: 2
Predicates: 3

Its longest line of descent runs back 7 generations to K890925 (1989). 20 ancestors in all. 2 later devices descend from it, 2 citing it directly. 1 of the 23 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 7 generations backK890925 Manan Bone Marrow Biopsy NeedleManan Medical Products, Inc. · 1989 · Recalled
6 generations backK961959 MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1996
5 generations backK980196 MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1998 · Recalled (Class I)
4 generations backK043523 Interv Brand Snarelok Bone Marrow Biopsy NeedleMedical Device Technologies, Inc. · 2005
3 generations backK072045 Oncontrol Bone Marrow Biopsy SystemVidacare Corporation · 2007
2 generations backK081713 Vertebral Access System by VidacareVidacare Corporation · 2008
1 generation backK112468 The Oncontrol Bone Access System by VidacareRegulatory Specialists, Inc. · 2011
This deviceK113872 The Oncontrol Bone Access and Bone Biopsy System by VidacareVidacare Corporation · 2012
Descendant · cites it directly · 0 of its ownK230015 OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone…Laurane Medical Sas · 2023
Descendant · cites it directly · 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 Marrow5 generations back · 1998

Most influential descendants

Showing 2 of 2 · See all

K230015OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power…Laurane Medical Sas · 2023 · cites it directly0descendants
K213896BD Trek Powered Bone Biopsy SystemBard Peripheral Vascular · 2022 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K890925	Manan Bone Marrow Biopsy Needle	Manan Medical Products, Inc.	1989	7
−6	K961959	MD Tech Biopsy Set for Bone and Bone Marrow	Medical Device Technologies, Inc.	1996	—
−5	K980196	MD Tech Biopsy Set for Bone and Bone Marrow	Medical Device Technologies, Inc.	1998	Class I
−4	K043523	Interv Brand Snarelok Bone Marrow Biopsy Needle	Medical Device Technologies, Inc.	2005	—
−3	K072045	Oncontrol Bone Marrow Biopsy System	Vidacare Corporation	2007	—
−2	K081713	Vertebral Access System by Vidacare	Vidacare Corporation	2008	—
−1	K112468	The Oncontrol Bone Access System by Vidacare	Regulatory Specialists, Inc.	2011	—
0 (this device)	K113872	The Oncontrol Bone Access and Bone Biopsy System by Vidacare	Vidacare Corporation	2012	—
+1	K230015	OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit…	Laurane Medical Sas	2023	—
+1	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
1996	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
2022	1	0
2023	1	0

FIG. 1 — Lineage of K113872, 1989–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K112468	The Oncontrol Bone Access System by Vidacare Summary page 1 …t, biopsy The legally marketed devices to which we are claiming equivalence [807.92(a) (3)]: 510(k)TrdorPoreayoMoeNaeMnfcur NumberTrdorPpreayoMoeNaeMnfcur I K1 12468 The OnControl ~ Bone Access System by Vidacare@ Vidlacare Corp. 2 K022169 Clearview P…	Regulatory Specialists, Inc.	2011	—
*	K022169	Clearview Plus Bone and Vertebral Body Biopsy Needles Summary page 1 …PoreayoMoeNaeMnfcur NumberTrdorPpreayoMoeNaeMnfcur I K1 12468 The OnControl ~ Bone Access System by Vidacare@ Vidlacare Corp. 2 K022169 Clearview Plus Bone and Vertebral Body Biopsy Needles Parallax Medical 3 K962425 The Bon…	Parallax Medical, Inc.	2002	—
*	K962425	Bonopty Coaxial Bone Biopsy System with Eccentric Drill (10-1072,3,4) Summary page 1 …dacare@ Vidlacare Corp. 2 K022169 Clearview Plus Bone and Vertebral Body Biopsy Needles Parallax Medical 3 K962425 The Bonopty@ Coaxial Bone Biopsy System with Eccentric Drill AprioMed Regulatory Specialists, Inc.…	Radi Medical Systems AB	1996	—

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K230015	OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power…	Laurane Medical Sas	2023	0
K213896	BD Trek Powered Bone Biopsy System	Bard Peripheral Vascular	2022	0

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 8, 2021	Class II	Z-1374-2021	Process design	Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy sample from being collected. Use of a defective device is likely to require immediate repeat biopsy, leading to a prolonged procedure
Nov 8, 2016	Class II	Z-0677-2017	Device Design	Sterility: Due to a potential incomplete seal on the outer sterile package.

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 · 5 generations back · ◆ on the line of descent in FIG. 13 Class I recalls

What does this lineage say?

The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
2 of the 20 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K230015 (Laurane Medical Sas, 2023) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · KNW

12in 2025

2007high 12 (2025) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNW

178in 2025

2007high 203 (2022) · low 35 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KNW

1in 2024

2007high 7 (2008) · low 0 (2015)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · KNW

1,667in 2025

2007high 5,120 (2020) · low 67 (2011)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 and Bone Biopsy System is intended for use

with a standard cement delivery system for the fixation of fractures of the

vertebral body using vertebroplasty and/or for bone biopsy of the vertebral

body and bone lesions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113872 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113872: The Oncontrol Bone Access and Bone Biopsy 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/K113872

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