510(k) · Cleared

Cleared

Clearview Plus Bone and Vertebral Body Biopsy Needles

K022169510(k) SpecialCleared Jul 25, 200222-day reviewClass II21 CFR 876.1075

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

Parallax Medical, Inc. · KNW Instrument, Biopsy

Cleared on Jul 25, 2002 as substantially equivalent to K011206 (Parallax Medical, Inc., 2001) after a 22-day review. Its family tree reaches back 1 generation to 2001. 34 later devices descend from it.

Decided: Jul 25, 2002
Review: 22 days
Class: Class II
Product code: KNW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011206 (2001). 34 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK011206 Parallax Bone and Vertebral Body Biopsy and Infusion NeedlesParallax Medical, Inc. · 2001
This deviceK022169 Clearview Plus Bone and Vertebral Body Biopsy NeedlesParallax Medical, Inc. · 2002
Descendant · cites it directly · 29 of its ownK032943 Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body…Stryker Corp. · 2003
Descendant · 2 generations on · 18 of its ownK060148 Ebi Vertebroplasty SystemsEbi, L.P. · 2006
Descendant · 3 generations on · 17 of its ownK063248 Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek · 2007
Descendant · 4 generations on · 10 of its ownK070293 Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc. · 2007
Descendant · 5 generations on · 9 of its ownK132817 Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

2003high 5 (2007) · low 0 (2004)2026

Most influential descendants

Showing 5 of 34 · See all

K032943Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone Biospsy KitsStryker Corp. · 2003 · cites it directly29descendants
K060148Ebi Vertebroplasty SystemsEbi, L.P. · 2006 · 2 generations on18descendants
K063248Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek · 2007 · 3 generations on17descendants
K070293Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc. · 2007 · 4 generations on10descendants
K132817Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014 · 5 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011206	Parallax Bone and Vertebral Body Biopsy and Infusion Needles	Parallax Medical, Inc.	2001	—
0 (this device)	K022169	Clearview Plus Bone and Vertebral Body Biopsy Needles	Parallax Medical, Inc.	2002	—
+1	K032943	Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone…	Stryker Corp.	2003	—
+2	K060148	Ebi Vertebroplasty Systems	Ebi, L.P.	2006	—
+3	K063248	Arcuate Vertebral Augmentation System	Medtronic Sofamor Danek	2007	—
+4	K070293	Benvenue VCF Osteo Coil System	Benvenue Medical, Inc.	2007	—
+5	K132817	Kiva VCF Treatment System	Benvenue Medical, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	1	0
2006	1	0
2007	5	0
2010	1	0
2011	2	0
2012	2	0
2013	1	0
2014	3	0
2017	3	0
2018	2	0
2019	1	0
2020	3	0
2021	1	0
2022	2	0
2023	2	0
2024	1	0
2025	2	0

FIG. 1 — Lineage of K022169, 2001–2025Source: 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.

Planning a device in KNW? 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

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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	Applicant	Decided	Recalls
*	K011206	Parallax Bone and Vertebral Body Biopsy and Infusion Needles	Parallax Medical, Inc.	2001	—

Also cleared against K011206: 1 other device →

What descends from it? (34)

See all 34

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

Number	Device	Applicant	Decided	Descendants
K032943	Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone Biospsy Kits	Stryker Corp.	2003	29
K112468	The Oncontrol Bone Access System by Vidacare	Regulatory Specialists, Inc.	2011	3
K113872	The Oncontrol Bone Access and Bone Biopsy System by Vidacare	Vidacare Corporation	2012	2
K052435	Pneumrx Family of Biopsy Needles and Kits	Pneumrx, Inc.	2005	0

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?

Its one ancestor has no recall.
Of its descendants, K032943 (Stryker Corp., 2003) has gone furthest, with 29 descendants of its own.
1 other device also cites its predicate K011206.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

Clearview Plus Bone and Vertebral Body Biopsy Needles are intended for use by a physician performing bone or vertebral body biopsy using a coring (cutting) or aspiration technique.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022169 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022169: Clearview Plus Bone and Vertebral Body Biopsy Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022169

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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