510(k) · Cleared

Recalled · 2008

Allez Spine Cross Connectors

K070460510(k) TraditionalCleared Jun 11, 2007115-day reviewClass II21 CFR 888.3070Recalls 1

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

Allez Spine, LLC · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Jun 11, 2007 as substantially equivalent to K003735 (Blackstone Medical, Inc., 2001) after a 115-day review. Its family tree reaches back 1 generation to 2001. It has been recalled once.

Decided: Jun 11, 2007
Review: 115 days
Class: Class II
Product code: NKB
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K003735 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK003735 Blackstone Spinal Fixation System, Second-Generation Cross-ConnectorBlackstone Medical, Inc. · 2001
This deviceK070460 Allez Spine Cross ConnectorsAllez Spine, LLC · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003735	Blackstone Spinal Fixation System, Second-Generation Cross-Connector	Blackstone Medical, Inc.	2001	—
0 (this device)	K070460	Allez Spine Cross Connectors	Allez Spine, LLC	2007	—

FIG. 1 — Lineage of K070460, 2001–2007Source: 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
*	K003735	Blackstone Spinal Fixation System, Second-Generation Cross-Connector Summary page 1 …ubstantially equivalent to the Blackstone Spinal Fixation System, Second-Generation Cross- Connector K003735 S/E May 8, 2001 Indications: The ALLEZ SPINE Cross Connectors are intended for posterior, non-…	Blackstone Medical, Inc.	2001	—

Also cleared against K003735: 7 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 21, 2008	Not classified	Z-0155-2009	Pending	This action is being taken voluntarily as a result of a Warning Letter issued to AlIez Spine LLC by the Food & Drug Administration. The Company decided it could better address the FDA's concerns regarding Current Good Manufacturing…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
7 other devices also cite its predicate K003735.

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?

The LAGUNA SPINAL SYSTEM is intended for posterior, non-cervical pedicle fixation for the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor pseudarthrosis; and/or failed previous fusion.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070460 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070460: Allez Spine Cross Connectors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070460

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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