510(k) · Cleared
ClearedPass 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 Apr 9, 2008 after an 86-day review. The FDA summary names its predicate without a number. 138 later devices descend from it.
- Decided
- Apr 9, 2008
- Review
- 86 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 0
138 later devices descend from it, 5 citing it directly.
- This deviceK080099 Pass Spinal SystemMedicrea Technologies · 2008
- Descendant · cites it directly · 136 of its ownK100297 Pass LP Spinal SystemMedicrea Technologies · 2010
- Descendant · cites it directly · 135 of its ownK083308 Pass LP Spinal SystemMedicrea Technologies · 2008
- 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
Showing 5 of 138 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 138 · See all- K100297Pass LP Spinal SystemMedicrea Technologies · 2010 · cites it directly136descendants
- K083308Pass LP Spinal SystemMedicrea Technologies · 2008 · cites it directly135descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080099 | Pass Spinal System | Medicrea Technologies | 2008 | — |
| +1 | K100297 | Pass LP Spinal System | Medicrea Technologies | 2010 | — |
| +1 | K083308 | Pass LP Spinal System | Medicrea Technologies | 2008 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 7 | 0 |
| 2018 | 8 | 0 |
| 2019 | 2 | 0 |
| 2020 | 6 | 0 |
| 2021 | 5 | 0 |
| 2022 | 12 | 0 |
| 2023 | 14 | 0 |
| 2024 | 19 | 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? (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 |
|---|---|---|---|
| * | — | similar previously cleared lumbar intervertebral body fusion devices Named without a submission number |
What descends from it? (138)
See all 1385 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, K100297 (Medicrea Technologies, 2010) has gone furthest, with 136 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. 2008, 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 2 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous…
Read the full statement (126 words)
The PASS 2 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: degenerative spondylolisthesis with objective evidence of neurological impairment,
fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion
(pseudoarthrosis).
When used as a pedicle screw system, the PASS 2 Spinal System is intended 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080099 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080099: Pass Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080099
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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