510(k) · Cleared

Cleared

Tangors Polyaxial System

K052385510(k) TraditionalCleared Dec 27, 2005119-day reviewClass II21 CFR 888.3070

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

Ulrich GmbH & Co. KG · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Dec 27, 2005 after a 119-day review. The FDA summary names no predicate by number. 253 later devices descend from it.

Decided: Dec 27, 2005
Review: 119 days
Class: Class II
Product code: NKB
Recalls: None
Predicates: 0

253 later devices descend from it, 3 citing it directly.

This deviceK052385 Tangors Polyaxial SystemUlrich GmbH & Co. KG · 2005
Descendant · cites it directly · 248 of its ownK070387 Expedium Spine SystemDepuy Spine, Inc. · 2007
Descendant · 2 generations on · 218 of its ownK102249 Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company · 2010
Descendant · 2 generations on · 203 of its ownK111571 Viper SystemsJohnson & Johnson · 2011
Descendant · 3 generations on · 94 of its ownK121020 Viper SystemDepuy Spine, Inc. · 2012
Descendant · 4 generations on · 84 of its ownK153442 CD HORIZON Spinal System, Medtronic Navigated Manual Reusable…Medtronic Sofamor Danek USA, Inc. · 2016

Showing 5 of 253 descendants. See all descendants

Descendants cleared per year

2007high 29 (2023) · low 1 (2007)2026

Most influential descendants

Showing 5 of 253 · See all

K070387Expedium Spine SystemDepuy Spine, Inc. · 2007 · cites it directly248descendants
K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company · 2010 · 2 generations on218descendants
K111571Viper SystemsJohnson & Johnson · 2011 · 2 generations on203descendants
K121020Viper SystemDepuy Spine, Inc. · 2012 · 3 generations on94descendants
K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc. · 2016 · 4 generations on84descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K052385	Tangors Polyaxial System	Ulrich GmbH & Co. KG	2005	—
+1	K070387	Expedium Spine System	Depuy Spine, Inc.	2007	—
+2	K102249	Expedium Spine System	Depuy Spine, A Johnson & Johnson Company	2010	—
+2	K111571	Viper Systems	Johnson & Johnson	2011	—
+3	K121020	Viper System	Depuy Spine, Inc.	2012	—
+4	K153442	CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for…	Medtronic Sofamor Danek USA, Inc.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	2	0
2009	1	0
2010	1	0
2011	1	0
2012	7	0
2013	13	0
2014	12	0
2015	13	0
2016	11	0
2017	8	0
2018	17	0
2019	13	0
2020	15	0
2021	11	0
2022	19	0
2023	29	0
2024	29	0
2025	28	0
2026	22	0

FIG. 1 — Lineage of K052385, 2005–2026Source: 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 NKB? 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 NKB device

#1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 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?

The FDA summary names no predicate by number.

What descends from it? (253)

See all 253

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

Number	Device	Applicant	Decided	Descendants
K070387	Expedium Spine System	Depuy Spine, Inc.	2007	248
K120891	Tangors Multifunctional Posterior System	Ulrich GmbH & Co. KG	2012	18
K123717	Ucentum	Ulrich GmbH & Co. KG	2013	17

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?

Of its descendants, K070387 (Depuy Spine, Inc., 2007) has gone furthest, with 248 descendants of its own.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NKB

24in 2025

2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007high 111 (2010) · low 57 (2024)2026

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

Recalls per year · NKB

1in 2025

2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, 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	38	87	4	34
2008	36	59	5	82
2009	44	71	33	171
2010	37	111	4	462
2011	48	84	3	577
2012	60	79	13	1,747
2013	35	73	0	1,962
2014	46	90	3 (1)	1,671
2015	55	90	3	1,446
2016	50	84	1	1,585
2017	63	69	1	1,618
2018	56	61	3	1,684
2019	39	84	1	1,915
2020	48	68	1	2,076
2021	32	61	0	1,745
2022	34	88	5	1,339
2023	44	72	2	919
2024	39	57	3	1,614
2025	24	61	1	1,171
2026	30	91	3	—

What is it indicated for?

The tangoRS Polyaxial System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and sacral spine. When used as a posterior spine thoracic/lumbar system, the tangoRS Polyaxial System is intended for the following indications: degenerative disc disease (as defined by back pain of discogenic with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., degenerative scoliosis, kyphosis, and/or lordosis), fracture, and spinal tumor.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052385 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052385: Tangors Polyaxial System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052385

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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