510(k) Report

510(k) · Cleared

Cleared

LDR Spine Easyspine Posterior Osteosynthesis System

K070341510(k) TraditionalCleared Aug 8, 2007183-day reviewClass II21 CFR 888.3050

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

Ldr Spine USA · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Aug 8, 2007 as substantially equivalent to K043094 (Ldr Spine USA, 2005) and 1 other predicate after a 183-day review. Its family tree reaches back 3 generations to 2004. 17 later devices descend from it.

Decided
Aug 8, 2007
Review
183 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K033826 (2004). 17 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2013: 1 descendant cleared2018: 2 descendants cleared2014: 1 descendant cleared2017: 1 descendant cleared2024: 2 descendants cleared2015: 1 descendant cleared2019: 1 descendant cleared2020: 1 descendant cleared2023: 2 descendants cleared2021: 2 descendants cleared2025: 1 descendant cleared2026: 1 descendant clearedK033826 · Orthopedic Alliance Spine System · Orthopedic Alliance, LLC · 2004 · recalledK043094 · Easyspine System · Ldr Spine USA · 2005K061017 · Easyspine System · Ldr Spine USA · 2006200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 6 descendants4 generations forward: 2 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant K061017 · Easyspine System · Ldr Spine USA · 2006K043094 · Easyspine System · Ldr Spine USA · 2005K033826 · Orthopedic Alliance Spine System · Orthopedic Alliance, LLC · 2004 · recalled0+5
  1. Root · 3 generations backK033826 Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC · 2004 · Recalled
  2. 2 generations backK043094 Easyspine SystemLdr Spine USA · 2005
  3. 1 generation backK061017 Easyspine SystemLdr Spine USA · 2006
  4. This deviceK070341 LDR Spine Easyspine Posterior Osteosynthesis SystemLdr Spine USA · 2007
  5. Descendant · cites it directly · 16 of its ownK121103 LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine…Ldr Spine USA, Inc. · 2012
  6. Descendant · 2 generations on · 8 of its ownK141129 Exactech Cervical Spacer SystemExactech, Inc. · 2014
  7. Descendant · 3 generations on · 7 of its ownK150130 Ascendant TM Cervical Spacer SystemExactech, Inc. · 2015
  8. Descendant · 3 generations on · 4 of its ownK191621 ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical…Choice Spine, LLC · 2019
  9. Descendant · 4 generations on · 3 of its ownK203311 ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC · 2021

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12014: 12015: 12017: 12018: 22019: 12020: 12021: 22023: 22024: 22025: 12026: 1
2012high 2 (2018) · low 0 (2016)2026

Most influential descendants

Showing 5 of 17 · See all
  • K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc. · 2012 · cites it directly16descendants
  • K141129Exactech Cervical Spacer SystemExactech, Inc. · 2014 · 2 generations on8descendants
  • K150130Ascendant TM Cervical Spacer SystemExactech, Inc. · 2015 · 3 generations on7descendants
  • K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC · 2019 · 3 generations on4descendants
  • K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC · 2021 · 4 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K033826Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC20041
−2K043094Easyspine SystemLdr Spine USA2005—
−1K061017Easyspine SystemLdr Spine USA2006—
0 (this device)K070341LDR Spine Easyspine Posterior Osteosynthesis SystemLdr Spine USA2007—
+1K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior…Ldr Spine USA, Inc.2012—
+2K141129Exactech Cervical Spacer SystemExactech, Inc.2014—
+3K150130Ascendant TM Cervical Spacer SystemExactech, Inc.2015—
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody…Choice Spine, LLC2019—
+4K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201410
201510
201710
201820
201910
202010
202120
202320
202420
202510
202610
FIG. 1 — Lineage of K070341, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 KWP? 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
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What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K043094Easyspine System
Summary page 1
…ew Spinal System - Class III per 888.3070 5. Legally Marketed Equivalent Predicate Devices: LDR Spine Easyspine System (K043094 and K061017) 6. Device Description The Easyspine System is designed to aid in the surgical correction of…
Ldr Spine USA2005—
*K061017Easyspine System
Summary page 1
…stem - Class III per 888.3070 5. Legally Marketed Equivalent Predicate Devices: LDR Spine Easyspine System (K043094 and K061017) 6. Device Description The Easyspine System is designed to aid in the surgical correction of several…
Ldr Spine USA2006—

Also cleared against K043094: 5 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.

NumberDeviceApplicantDecidedDescendants
K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc.201216

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?

  • The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 12 months on median.
  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K121103 (Ldr Spine USA, Inc., 2012) has gone furthest, with 16 descendants of its own.
  • 5 other devices also cite its predicate K043094.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · KWP

9in 2015

2007: 142008: 132009: 122010: 142011: 122012: 182013: 122014: 132015: 9
2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007: 96 days median2008: 50 days median2009: 89 days median2010: 186 days median2011: 67 days median2012: 112 days median2013: 99 days median2014: 138 days median2015: 113 days median
2007high 186 (2010) · low 50 (2008)2026

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

Recalls per year · KWP

2in 2022

2007: 22008: 12009: 232010: 22011: 62012: 12013: 32015: 12016: 32018: 12019: 22022: 2
2007high 23 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWP

494in 2025

2007: 2102008: 5942009: 6822010: 4742011: 7922012: 9182013: 1,0902014: 1,0222015: 1,3482016: 1,3792017: 8642018: 6572019: 5182020: 7962021: 5252022: 3352023: 3322024: 4362025: 494
2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200714962210
200813501594
2009128923682
2010141862474
201112676792
2012181121918
2013129931,090
20141313801,022
2015911311,348
20160—31,379
20170—0864
20180—1657
20190—2518
20200—0796
20210—0525
20220—2335
20230—0332
20240—0436
20250—0494
20260—0—

What is it indicated for?

The Easyspine System is a posterior, noncervical pedicle and non-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 of the thoracic, lumbar and sacral spine:

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

Deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis)

Tumor

Pseudoarthrosis

Failed previous fusion

Indications for use as stated in the FDA summary.

Also cleared against K043094

5 other devices cite the same predicate.

  • K123134Easyspine SystemLdr Spine USA, Inc. · 2013
  • K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal System, LDR Spine Usa…Ldr Spine USA, Inc. · 2012
  • K082592LDR Spine Easyspine SystemLdr Spine USA · 2008
  • K063794Modification to Easyspine SystemLdr Spine USA · 2007
  • K061017Easyspine SystemLdr Spine USA · 2006

More from Ldr Spine USA

25 FDA decisions under this applicant name. See the company

  • K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant SystemLdr Spine USA · 20161 recall
  • K152137FacetBRIDGE SystemLdr Spine USA · 2016
  • K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA · 2015
  • K150765LDR Spine ROI-C Cervical Cage SystemLdr Spine USA · 2015
  • K110327LDR Spine Roi-a Interbody Fusion SystemLdr Spine USA · 2011

Recent decisions in KWP

The KWP category page

  • K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
  • K150753OASYS SystemStryker Corporation · 2015
  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
  • K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 20153 recalls

https://510kreport.com/device/K070341 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070341: LDR Spine Easyspine Posterior Osteosynthesis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070341

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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