510(k) · Cleared
ClearedEasyspine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ldr Spine USA · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Aug 10, 2006 as substantially equivalent to K043094 (Ldr Spine USA, 2005) after a 119-day review. Its family tree reaches back 2 generations to 2004. 50 later devices descend from it.
- Decided
- Aug 10, 2006
- Review
- 119 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K033826 (2004). 50 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK033826 Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC · 2004 · Recalled
- 1 generation backK043094 Easyspine SystemLdr Spine USA · 2005
- This deviceK061017 Easyspine SystemLdr Spine USA · 2006
- Descendant · cites it directly · 30 of its ownK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
- 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
- Descendant · 2 generations on · 16 of its ownK143334 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
- Descendant · 2 generations on · 16 of its ownK121103 LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine…Ldr Spine USA, Inc. · 2012
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K141873Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014 · cites it directly30descendants
- K070341LDR Spine Easyspine Posterior Osteosynthesis SystemLdr Spine USA · 2007 · cites it directly17descendants
- K063794Modification to Easyspine SystemLdr Spine USA · 2007 · cites it directly17descendants
- K143334Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015 · 2 generations on16descendants
- K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc. · 2012 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K033826 | Orthopedic Alliance Spine System | Orthopedic Alliance, LLC | 2004 | 1 |
| −1 | K043094 | Easyspine System | Ldr Spine USA | 2005 | — |
| 0 (this device) | K061017 | Easyspine System | Ldr Spine USA | 2006 | — |
| +1 | K141873 | Range/Mesa/Denali Spinal System | K2m, Inc. | 2014 | — |
| +1 | K070341 | LDR Spine Easyspine Posterior Osteosynthesis System | Ldr Spine USA | 2007 | — |
| +1 | K063794 | Modification to Easyspine System | Ldr Spine USA | 2007 | — |
| +2 | K143334 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2015 | — |
| +2 | K121103 | LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior… | Ldr Spine USA, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 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 |
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
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 | Decided |
|---|---|---|---|
| * | K043094 | Easyspine SystemSummary page 1…edicle Screw Spinal System (21 CFR §888.3070, Product Codes IVIN and MNH) 5. Legally Marketed Equivalent Predicate Device K043094 - LDR Spine USA Easyspine System consisting of rods, connectors, and Standard and a pedicle screws. 510(K<) Summary… | 2005 |
What descends from it? (50)
See all 503 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 2 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K141873 (K2m, Inc., 2014) has gone furthest, with 30 descendants of its own.
- 5 other devices also cite its predicate K043094.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 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 Spine USA 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/K061017 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061017: Easyspine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061017
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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