510(k) · Cleared

Cleared

Arx-Link Cross Connector

K070995510(k) SpecialCleared Jun 22, 200774-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

Life Spine · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Jun 22, 2007 as substantially equivalent to K061600 (Life Spine, 2006) after a 74-day review. Its family tree reaches back 1 generation to 2006. 17 later devices descend from it.

Decided: Jun 22, 2007
Review: 74 days
Class: Class II
Product code: NKB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K061600 (2006). 17 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK061600 Arx Spinal SystemLife Spine · 2006
This deviceK070995 Arx-Link Cross ConnectorLife Spine · 2007
Descendant · cites it directly · 16 of its ownK073480 Life Spine Cross ConnectorLife Spine · 2008
Descendant · 2 generations on · 15 of its ownK132866 Nautilus Spinal SystemLife Spine, Inc. · 2013
Descendant · 3 generations on · 13 of its ownK141222 Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015
Descendant · 4 generations on · 12 of its ownK151196 Nautilus Spinal SystemLife Spine, Inc. · 2015
Descendant · 5 generations on · 10 of its ownK191575 ARx Spinal SystemLife Spine, Inc. · 2019

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2008high 3 (2015) · low 0 (2009)2026

Most influential descendants

Showing 5 of 17 · See all

K073480Life Spine Cross ConnectorLife Spine · 2008 · cites it directly16descendants
K132866Nautilus Spinal SystemLife Spine, Inc. · 2013 · 2 generations on15descendants
K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015 · 3 generations on13descendants
K151196Nautilus Spinal SystemLife Spine, Inc. · 2015 · 4 generations on12descendants
K191575ARx Spinal SystemLife Spine, Inc. · 2019 · 5 generations on10descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K061600	Arx Spinal System	Life Spine	2006	—
0 (this device)	K070995	Arx-Link Cross Connector	Life Spine	2007	—
+1	K073480	Life Spine Cross Connector	Life Spine	2008	—
+2	K132866	Nautilus Spinal System	Life Spine, Inc.	2013	—
+3	K141222	Nautilus Spinal System and Solstice Oct System	Life Spine, Inc.	2015	—
+4	K151196	Nautilus Spinal System	Life Spine, Inc.	2015	—
+5	K191575	ARx Spinal System	Life Spine, Inc.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2013	1	0
2015	3	0
2019	2	0
2020	2	0
2021	2	0
2022	2	0
2023	1	0
2024	1	0
2026	2	0

FIG. 1 — Lineage of K070995, 2006–2026Source: 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

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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
*	K061600	Arx Spinal System Summary page 1 …NKB, 21 CER 888.3070, Class III Predicate Device: Life Spine ARX(® Spinal Implant System K06 1600 Device Description: The ARX-LinkTM' Cross Connector is a titanium alloy, multiple compon…	Life Spine	2006	—

Also cleared against K061600: 4 other devices →

What descends from it? (17)

See all 17

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K073480	Life Spine Cross Connector	Life Spine	2008	16

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, K073480 (Life Spine, 2008) has gone furthest, with 16 descendants of its own.
4 other devices also cite its predicate K061600.

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. 2007, this device’s year, is highlighted.

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?

ARX® Spinal System Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing. The ARX® Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides…

Read the full statement (148 words)

ARX® Spinal System

Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The ARX® Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion.

When used as a posterior spine thoracic/lumbar system, the ARX® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070995 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070995: Arx-Link Cross Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070995

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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