510(k) · Cleared

Cleared

Easyspine System

K043094510(k) TraditionalCleared Feb 11, 200594-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

Ldr Spine USA · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Feb 11, 2005 as substantially equivalent to K033826 (Orthopedic Alliance, LLC, 2004) after a 94-day review. Its family tree reaches back 1 generation to 2004. 55 later devices descend from it.

Decided: Feb 11, 2005
Review: 94 days
Class: Class II
Product code: MNI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K033826 (2004). 55 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK033826 Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC · 2004 · Recalled
This deviceK043094 Easyspine SystemLdr Spine USA · 2005
Descendant · cites it directly · 50 of its ownK061017 Easyspine SystemLdr Spine USA · 2006
Descendant · 2 generations on · 30 of its ownK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
Descendant · cites it directly · 20 of its ownK082592 LDR Spine Easyspine SystemLdr Spine USA · 2008
Descendant · cites it directly · 17 of its ownK070341 LDR Spine Easyspine Posterior Osteosynthesis SystemLdr Spine USA · 2007
Descendant · cites it directly · 17 of its ownK063794 Modification to Easyspine SystemLdr Spine USA · 2007

Showing 5 of 55 descendants. See all descendants

Descendants cleared per year

2006high 9 (2024) · low 0 (2009)2026

Most influential descendants

Showing 5 of 55 · See all

K061017Easyspine SystemLdr Spine USA · 2006 · cites it directly50descendants
K141873Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014 · 2 generations on30descendants
K082592LDR Spine Easyspine SystemLdr Spine USA · 2008 · cites it directly20descendants
K070341LDR Spine Easyspine Posterior Osteosynthesis SystemLdr Spine USA · 2007 · cites it directly17descendants
K063794Modification to Easyspine SystemLdr Spine USA · 2007 · cites it directly17descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K033826	Orthopedic Alliance Spine System	Orthopedic Alliance, LLC	2004	1
0 (this device)	K043094	Easyspine System	Ldr Spine USA	2005	—
+1	K061017	Easyspine System	Ldr Spine USA	2006	—
+2	K141873	Range/Mesa/Denali Spinal System	K2m, Inc.	2014	—
+1	K082592	LDR Spine Easyspine System	Ldr Spine USA	2008	—
+1	K070341	LDR Spine Easyspine Posterior Osteosynthesis System	Ldr Spine USA	2007	—
+1	K063794	Modification to Easyspine System	Ldr Spine USA	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	2	0
2008	1	0
2012	1	0
2013	1	0
2014	5	0
2015	5	0
2016	3	0
2017	3	0
2018	7	0
2019	1	0
2020	2	0
2021	3	0
2022	2	0
2023	5	0
2024	9	0
2025	1	0
2026	3	0

FIG. 1 — Lineage of K043094, 2004–2026Source: 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 MNI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

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
*	K033826	Orthopedic Alliance Spine System Summary page 1 …em Classification Pedicle Screw Spinal System Name(s): 4. Equivalent PredicateDevice: Orthopedic Alliance Spine System, K033826, Orthopedic Alliance, LLC. 5. Classification(s): § 888.3070 - Pedicle Screw Spinal System (Class II Uses)…	Orthopedic Alliance, LLC	2004	1

Also cleared against K033826: 2 other devices →

What descends from it? (55)

See all 55

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

Number	Device	Applicant	Decided	Descendants
K061017	Easyspine System	Ldr Spine USA	2006	50
K082592	LDR Spine Easyspine System	Ldr Spine USA	2008	20
K070341	LDR Spine Easyspine Posterior Osteosynthesis System	Ldr Spine USA	2007	17
K063794	Modification to Easyspine System	Ldr Spine USA	2007	17
K121103	LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…	Ldr Spine USA, Inc.	2012	16
K123134	Easyspine System	Ldr Spine USA, Inc.	2013	1

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 a recall.
Of its descendants, K061017 (Ldr Spine USA, 2006) has gone furthest, with 50 descendants of its own.
2 other devices also cite its predicate K033826.

How does its category compare?

All MNI devices

MNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNI

1in 2017

2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007high 168 (2016) · low 54 (2015)2026

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

Recalls per year · MNI

1in 2018

2007high 26 (2007) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MNI

80in 2025

2007high 824 (2013) · low 80 (2025)2025

MAUDE reports naming product code MNI, 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	20	82	26	83
2008	23	64	8	108
2009	18	86	3	138
2010	16	74	1	126
2011	17	111	0	146
2012	19	75	1	200
2013	14	77	4	824
2014	6	104	0	301
2015	12	54	1	260
2016	7	168	0	117
2017	1	—	0	247
2018	0	—	1	134
2019	0	—	0	188
2020	0	—	0	115
2021	0	—	0	270
2022	0	—	0	214
2023	0	—	0	122
2024	0	—	0	114
2025	0	—	0	80
2026	0	—	0	—

What is it indicated for?

The LDR Easyspine System is a posterior, noncervical, pedicle system intended to

provide immobilization and stabilization of spinal segments in skeletally mature

patients as an adjunct to fusion in the treatment of the following acute and chronic

instabilities or deformities of the thoracic, lumbar, and sacral spine:

spondylolisthesis (grades 3 and 4 at L5-S1 or degenerative spondylolisthesis with

objective evidence of neurologic impairment), trauma (i.e., fracture or dislocation),

spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),

tumor, pseudoarthrosis, and failed previous fusion.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043094 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043094: Easyspine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043094

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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