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 Mar 4, 2010 as substantially equivalent to K080099 (Medicrea Technologies, 2008) and 1 other predicate after a 30-day review. Its family tree reaches back 6 generations to 2000. 136 later devices descend from it.
- Decided
- Mar 4, 2010
- Review
- 30 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K992147 (2000). 17 ancestors in all, the oldest K000319 (2000). 136 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK992147 Triple-Fix Spinal Fixation SystemAdvanced Spine Technology, Inc. · 2000
- 5 generations backK001668 Global Spinal Fixation SystemD.K.M. Co., Ltd. · 2000
- 4 generations backK031455 Conklusion Pedicle Screw SystemSignus Medical, LLC · 2003
- 3 generations backK070933 Lowtop Pedicle Screw SystemSanacor · 2007
- 2 generations backK072187 Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2007
- 1 generation backK080518 Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology · 2008
- This deviceK100297 Pass LP Spinal SystemMedicrea Technologies · 2010
- 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 136 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 136 · 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 |
|---|---|---|---|---|---|
| −6 | K992147 | Triple-Fix Spinal Fixation System | Advanced Spine Technology, Inc. | 2000 | — |
| −5 | K001668 | Global Spinal Fixation System | D.K.M. Co., Ltd. | 2000 | — |
| −4 | K031455 | Conklusion Pedicle Screw System | Signus Medical, LLC | 2003 | — |
| −3 | K070933 | Lowtop Pedicle Screw System | Sanacor | 2007 | — |
| −2 | K072187 | Pioneer Lowtop Spinal Rod System | Pioneer Surgical Technology | 2007 | — |
| −1 | K080518 | Pioneer Surgical Technology Quantum Spinal System | Pioneer Surgical Technology | 2008 | — |
| 0 (this device) | K100297 | Pass LP Spinal System | Medicrea Technologies | 2010 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K080099 | Pass Spinal SystemSummary page 1…0 Device panel Orthopedic Legally marketed predicate {PASS LP Spinal System (MEDICREA) = K080099 devices IQUANTUM Spinal System (PIONEER) = K080518 Reason for Special 51 0(k)__ Product range extension and ad… | 2008 |
| * | K080518 | Pioneer Surgical Technology Quantum Spinal SystemSummary page 1…ted predicate {PASS LP Spinal System (MEDICREA) = K080099 devices IQUANTUM Spinal System (PIONEER) = K080518 Reason for Special 51 0(k)__ Product range extension and additional components Submitter MEDICR… | 2008 |
What descends from it? (136)
See all 1363 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 10 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 17 ancestors have a recall of any class.
- Of its descendants, K110497 (Medicrea International, 2011) has gone furthest, with 133 descendants of its own.
- 4 other devices also cite its predicate K080099.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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/K100297 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100297: Pass LP 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/K100297
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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