510(k) · Cleared
ClearedPass LP Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicrea Technologies · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Jul 31, 2009 after a 221-day review. The FDA summary names no predicate by number. 146 later devices descend from it.
- Decided
- Jul 31, 2009
- Review
- 221 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 0
146 later devices descend from it, 3 citing it directly.
- This deviceK083810 Pass LP Spinal SystemMedicrea Technologies · 2009
- Descendant · cites it directly · 133 of its ownK110497 Pass LP Spinal SystemMedicrea International · 2011 · Recalled
- Descendant · 2 generations on · 132 of its ownK123138 Pass LP Spinal SystemMedicrea International · 2013
- Descendant · 3 generations on · 84 of its ownK142798 PASS LP Spinal SystemMedicrea International SA · 2015
- Descendant · 4 generations on · 83 of its ownK152968 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
- Descendant · 5 generations on · 75 of its ownK161363 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2016
Showing 5 of 146 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 146 · See all- K110497Pass LP Spinal SystemMedicrea International · 2011 · cites it directly133descendants
- K123138Pass LP Spinal SystemMedicrea International · 2013 · 2 generations on132descendants
- K142798PASS LP Spinal SystemMedicrea International SA · 2015 · 3 generations on84descendants
- K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015 · 4 generations on83descendants
- K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2016 · 5 generations on75descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K083810 | Pass LP Spinal System | Medicrea Technologies | 2009 | — |
| +1 | K110497 | Pass LP Spinal System | Medicrea International | 2011 | 1 |
| +2 | K123138 | Pass LP Spinal System | Medicrea International | 2013 | — |
| +3 | K142798 | PASS LP Spinal System | Medicrea International SA | 2015 | — |
| +4 | K152968 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2015 | — |
| +5 | K161363 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 8 | 0 |
| 2018 | 10 | 0 |
| 2019 | 2 | 0 |
| 2020 | 6 | 0 |
| 2021 | 5 | 0 |
| 2022 | 12 | 0 |
| 2023 | 16 | 0 |
| 2024 | 25 | 0 |
| 2025 | 24 | 0 |
| 2026 | 24 | 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?
The FDA summary names no predicate by number.
What descends from it? (146)
See all 1463 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?
- Of its descendants, K110497 (Medicrea International, 2011) has gone furthest, with 133 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. 2009, 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 PASS LP Spinal System includes a 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 thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological…
Read the full statement (191 words)
The PASS LP Spinal System includes a 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 thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous
fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective
evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis
and loss of stability due to tumors.
The PASS LP Spinal System is also indicated for pedicle screw fixation for the treatment
of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae 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.
The PASS LP also includes hooks, rods and sacral/iliac screws indicated for
degenerative disc disease (ddd) 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 and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083810: Pass LP Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083810
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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