510(k) · Cleared
ClearedLDR Spine Easyspine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ldr Spine USA · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 8, 2008 as substantially equivalent to K043094 (Ldr Spine USA, 2005) after a 30-day review. Its family tree reaches back 2 generations to 2004. 20 later devices descend from it.
- Decided
- Oct 8, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K033826 (2004). 20 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK033826 Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC · 2004 · Recalled
- 1 generation backK043094 Easyspine SystemLdr Spine USA · 2005
- This deviceK082592 LDR Spine Easyspine SystemLdr Spine USA · 2008
- 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 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · 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 |
|---|---|---|---|---|---|
| −2 | K033826 | Orthopedic Alliance Spine System | Orthopedic Alliance, LLC | 2004 | 1 |
| −1 | K043094 | Easyspine System | Ldr Spine USA | 2005 | — |
| 0 (this device) | K082592 | LDR Spine Easyspine System | Ldr Spine USA | 2008 | — |
| +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 | 4 | 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 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
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 2…Kos525 JLDR a passion for innovation 5. Legally Marketed Equivalent Predicate Devices: LDR Spine Easyspine System (K043094) 6. Device Description Easyspine ® implants are single use devices for mono-and multi-segmental stabilization of the lumba… | 2005 |
What descends from it? (20)
See all 204 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 4 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 2 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 NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 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 LDR 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 or deformities 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.
https://510kreport.com/device/K082592 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082592: LDR Spine 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/K082592
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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