510(k) · Cleared
ClearedModification to Easyspine 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 Jan 24, 2007 as substantially equivalent to K043094 (Ldr Spine USA, 2005) and 1 other predicate after a 33-day review. Its family tree reaches back 3 generations to 2004. 17 later devices descend from it.
- Decided
- Jan 24, 2007
- Review
- 33 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K033826 (2004). 17 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK033826 Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC · 2004 · Recalled
- 2 generations backK043094 Easyspine SystemLdr Spine USA · 2005
- 1 generation backK061017 Easyspine SystemLdr Spine USA · 2006
- This deviceK063794 Modification to Easyspine SystemLdr Spine USA · 2007
- 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
- Descendant · 2 generations on · 8 of its ownK141129 Exactech Cervical Spacer SystemExactech, Inc. · 2014
- Descendant · 3 generations on · 7 of its ownK150130 Ascendant TM Cervical Spacer SystemExactech, Inc. · 2015
- Descendant · 3 generations on · 4 of its ownK191621 ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical…Choice Spine, LLC · 2019
- 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
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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K033826 | Orthopedic Alliance Spine System | Orthopedic Alliance, LLC | 2004 | 1 |
| −2 | K043094 | Easyspine System | Ldr Spine USA | 2005 | — |
| −1 | K061017 | Easyspine System | Ldr Spine USA | 2006 | — |
| 0 (this device) | K063794 | Modification to Easyspine System | Ldr Spine USA | 2007 | — |
| +1 | K121103 | LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior… | Ldr Spine USA, Inc. | 2012 | — |
| +2 | K141129 | Exactech Cervical Spacer System | Exactech, Inc. | 2014 | — |
| +3 | K150130 | Ascendant TM Cervical Spacer System | Exactech, Inc. | 2015 | — |
| +3 | K191621 | ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody… | Choice Spine, LLC | 2019 | — |
| +4 | K203311 | ChoiceSpine Blackhawk Ti Cervical Spacer System | Choice Spine, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043094 | Easyspine SystemSummary page 1…ions are reviewed by the Orthopedic Devices Branch. PREDICATE DEVICE INFORMATION The predicate device for this modification is the Easyspine System cleared by FDA under K043094 and K061017. Page 152 of 153 === Pa… | 2005 |
| * | K061017 | Easyspine SystemSummary page 1…iewed by the Orthopedic Devices Branch. PREDICATE DEVICE INFORMATION The predicate device for this modification is the Easyspine System cleared by FDA under K043094 and K061017. Page 152 of 153 51… | 2006 |
What descends from it? (17)
See all 172 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 3 years and passes through 2 companies; a new generation was cleared every 7 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 MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 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/K063794 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063794: Modification to Easyspine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063794
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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