510(k) · Cleared
Recalled · Class II · 2023Pass LP Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicrea International · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Sep 26, 2011 as substantially equivalent to K062136 (Medicrea, 2006) and 6 other predicates after a 216-day review. Its family tree reaches back 7 generations to 2000. 133 later devices descend from it. It has been recalled once.
- Decided
- Sep 26, 2011
- Review
- 216 days
- Class
- Class II
- Product code
- MNH
- Recalls
- 1
- Predicates
- 7
Its longest line of descent runs back 7 generations to K992147 (2000). 33 ancestors in all, the oldest K955348 (1996). 133 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK992147 Triple-Fix Spinal Fixation SystemAdvanced Spine Technology, Inc. · 2000
- 6 generations backK001668 Global Spinal Fixation SystemD.K.M. Co., Ltd. · 2000
- 5 generations backK031455 Conklusion Pedicle Screw SystemSignus Medical, LLC · 2003
- 4 generations backK070933 Lowtop Pedicle Screw SystemSanacor · 2007
- 3 generations backK072187 Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2007
- 2 generations backK080518 Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology · 2008
- 1 generation backK100297 Pass LP Spinal SystemMedicrea Technologies · 2010
- This deviceK110497 Pass LP Spinal SystemMedicrea International · 2011
- Descendant · cites it directly · 132 of its ownK123138 Pass LP Spinal SystemMedicrea International · 2013
- Descendant · 2 generations on · 84 of its ownK142798 PASS LP Spinal SystemMedicrea International SA · 2015
- Descendant · 3 generations on · 83 of its ownK152968 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
- Descendant · 4 generations on · 75 of its ownK161363 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2016
- Descendant · 4 generations on · 70 of its ownK181677 Kodiak Spinal Fixation SystemAlphatec Spine, Inc. · 2018
Showing 5 of 133 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 133 · See all- K123138Pass LP Spinal SystemMedicrea International · 2013 · cites it directly132descendants
- K142798PASS LP Spinal SystemMedicrea International SA · 2015 · 2 generations on84descendants
- K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015 · 3 generations on83descendants
- K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2016 · 4 generations on75descendants
- K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc. · 2018 · 4 generations on70descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K992147 | Triple-Fix Spinal Fixation System | Advanced Spine Technology, Inc. | 2000 | — |
| −6 | K001668 | Global Spinal Fixation System | D.K.M. Co., Ltd. | 2000 | — |
| −5 | K031455 | Conklusion Pedicle Screw System | Signus Medical, LLC | 2003 | — |
| −4 | K070933 | Lowtop Pedicle Screw System | Sanacor | 2007 | — |
| −3 | K072187 | Pioneer Lowtop Spinal Rod System | Pioneer Surgical Technology | 2007 | — |
| −2 | K080518 | Pioneer Surgical Technology Quantum Spinal System | Pioneer Surgical Technology | 2008 | — |
| −1 | K100297 | Pass LP Spinal System | Medicrea Technologies | 2010 | — |
| 0 (this device) | K110497 | Pass LP Spinal System | Medicrea International | 2011 | — |
| +1 | K123138 | Pass LP Spinal System | Medicrea International | 2013 | — |
| +2 | K142798 | PASS LP Spinal System | Medicrea International SA | 2015 | — |
| +3 | K152968 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2015 | — |
| +4 | K161363 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2016 | — |
| +4 | K181677 | Kodiak Spinal Fixation System | Alphatec Spine, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 3 | 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 MNH? 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? (7)
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 |
|---|---|---|---|
| * | K062136 | Pass 2 Spinal SystemSummary page 1…WP CFR section 1888.3070 /888.3050 Device panel 1Orthopedic Legally marketed predicate PASS LP Spinal System (MEDICREA) = K062136, KO80099, K082069, K082577, devices IK083308, K083810, K100297 Reason for Special 510(k) 1Additio… | 2006 |
| * | K080099 | Pass Spinal System | 2008 |
| * | K082069 | Pass 2 Spinal SystemSummary page 1…1888.3070 /888.3050 Device panel 1Orthopedic Legally marketed predicate PASS LP Spinal System (MEDICREA) = K062136, KO80099, K082069, K082577, devices IK083308, K083810, K100297 Reason for Special 510(k) 1Addition of a component a… | 2008 |
| * | K082577 | Pass LP Spinal SystemSummary page 1…1888.3070 /888.3050 Device panel 1Orthopedic Legally marketed predicate PASS LP Spinal System (MEDICREA) = K062136, KO80099, K082069, K082577, devices IK083308, K083810, K100297 Reason for Special 510(k) 1Addition of a component and implan… | 2008 |
| * | K083308 | Pass LP Spinal SystemSummary page 1…1Orthopedic Legally marketed predicate PASS LP Spinal System (MEDICREA) = K062136, KO80099, K082069, K082577, devices IK083308, K083810, K100297 Reason for Special 510(k) 1Addition of a component and implants delivered sterile Submitter… | 2008 |
| * | K083810 | Pass LP Spinal SystemSummary page 1…1Orthopedic Legally marketed predicate PASS LP Spinal System (MEDICREA) = K062136, KO80099, K082069, K082577, devices IK083308, K083810, K100297 Reason for Special 510(k) 1Addition of a component and implants delivered sterile Submitter… | 2009 |
| * | K100297 | Pass LP Spinal SystemSummary page 1…1Orthopedic Legally marketed predicate PASS LP Spinal System (MEDICREA) = K062136, KO80099, K082069, K082577, devices IK083308, K083810, K100297 Reason for Special 510(k) 1Addition of a component and implants delivered sterile Submitter MEDIC… | 2010 |
What descends from it? (133)
See all 1331 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123138 | Pass LP Spinal System | 2013 | 132 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 12, 2023 | Class II | Z-2458-2023 | Under Investigation by firm | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 33 ancestors have a recall of any class.
- Of its descendants, K123138 (Medicrea International, 2013) has gone furthest, with 132 descendants of its own.
- 2 other devices also cite its predicate K062136.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K110497 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110497: 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/K110497
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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