510(k) · Cleared
Recalled · Class II · 2013Orthopedic Alliance Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthopedic Alliance, LLC · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Jul 1, 2004 after a 204-day review. The FDA summary names its predicate without a number. 135 later devices descend from it. It has been recalled once.
- Decided
- Jul 1, 2004
- Review
- 204 days
- Class
- Class II
- Product code
- MNI
- Recalls
- 1
- Predicates
- 0
135 later devices descend from it, 3 citing it directly.
- This deviceK033826 Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC · 2004
- Descendant · cites it directly · 77 of its ownK043484 Lanx Spinal Fixation SystemLanx, LLC · 2005
- Descendant · 2 generations on · 75 of its ownK071877 Lanx Spinal Fixation SystemLanx, LLC · 2007
- Descendant · cites it directly · 55 of its ownK043094 Easyspine SystemLdr Spine USA · 2005
- Descendant · 2 generations on · 50 of its ownK061017 Easyspine SystemLdr Spine USA · 2006
- Descendant · 3 generations on · 37 of its ownK100354 Primal OK Interspinous Fusion SystemOsteomed LP · 2010
Showing 5 of 135 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 135 · See all- K043484Lanx Spinal Fixation SystemLanx, LLC · 2005 · cites it directly77descendants
- K071877Lanx Spinal Fixation SystemLanx, LLC · 2007 · 2 generations on75descendants
- K043094Easyspine SystemLdr Spine USA · 2005 · cites it directly55descendants
- K061017Easyspine SystemLdr Spine USA · 2006 · 2 generations on50descendants
- K100354Primal OK Interspinous Fusion SystemOsteomed LP · 2010 · 3 generations on37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033826 | Orthopedic Alliance Spine System | Orthopedic Alliance, LLC | 2004 | — |
| +1 | K043484 | Lanx Spinal Fixation System | Lanx, LLC | 2005 | — |
| +2 | K071877 | Lanx Spinal Fixation System | Lanx, LLC | 2007 | — |
| +1 | K043094 | Easyspine System | Ldr Spine USA | 2005 | — |
| +2 | K061017 | Easyspine System | Ldr Spine USA | 2006 | — |
| +3 | K100354 | Primal OK Interspinous Fusion System | Osteomed LP | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 9 | 0 |
| 2013 | 11 | 0 |
| 2014 | 13 | 0 |
| 2015 | 12 | 0 |
| 2016 | 7 | 0 |
| 2017 | 7 | 0 |
| 2018 | 11 | 0 |
| 2019 | 2 | 0 |
| 2020 | 6 | 0 |
| 2021 | 6 | 0 |
| 2022 | 6 | 0 |
| 2023 | 10 | 0 |
| 2024 | 12 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 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? (3)
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 |
|---|---|---|---|
| * | — | Xia Spinal System (Stryker Howmedica) Named without a submission number | |
| * | — | Global Spinal Fixation System (U & I Corp.) Named without a submission number | |
| * | — | Synergy Spine System (Interpore Cross) Named without a submission number |
What descends from it? (135)
See all 1353 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 7, 2013 | Class II | Z-1156-2013 | Device Design | Orthopedic Alliance is recalling Blue & Gold Implants and Instruments because the Blue & Gold system is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. These inadequacies… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K043484 (Lanx, LLC, 2005) has gone furthest, with 77 descendants of its own.
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 Orthopedic Alliance Spine System is a pedicle screw 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 spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and…
Read the full statement (132 words)
The Orthopedic Alliance Spine System is a pedicle screw 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 spondylolisthesis with objective evidence of
neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous
fusion ( pseudarthrosis ).
The Orthopedic Alliance Spine System is also indicated for pedicle screw fixation for the treatment
of severe spondylolisthesis ( grades 3 and 4 ) of the L5-SI vertebra in skeletally mature patients
receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine
( L3 to sacrum ) with removal of the implants after the attainment of a solid fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033826 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033826: Orthopedic Alliance Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033826
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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