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 International · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Nov 21, 2011 as substantially equivalent to K062136 (Medicrea, 2006) and 8 other predicates after an 84-day review. Its family tree reaches back 8 generations to 1984. 1 later device descends from it.
- Decided
- Nov 21, 2011
- Review
- 84 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 8 generations to K841189 (1984). 49 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 6 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 5 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 3 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 2 generations backK050058 Theken Reveal VBR SystemTheken Surgical,Llc · 2005
- 1 generation backK080822 VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC · 2008 · Recalled
- This deviceK112493 Pass LP Spinal SystemMedicrea International · 2011
- Descendant · cites it directly · 0 of its ownK153413 PASS LP Spinal SystemMedicrea International SA · 2016
Most influential descendants
Showing 1 of 1 · See all- K153413PASS LP Spinal SystemMedicrea International SA · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −7 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −6 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −5 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −3 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −2 | K050058 | Theken Reveal VBR System | Theken Surgical,Llc | 2005 | — |
| −1 | K080822 | VU Apod Intervertabral Body Fusion Device | Theken Spine, LLC | 2008 | 1 |
| 0 (this device) | K112493 | Pass LP Spinal System | Medicrea International | 2011 | — |
| +1 | K153413 | PASS LP Spinal System | Medicrea International SA | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 6 | 0 |
| 2001 | 6 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 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? (10)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062136 | Pass 2 Spinal SystemSummary page 1…DESCRIPTION OF DEVICE MODIFICATION The purpose of this submission is to submit the new spinal system PASS MIS. This new device and PASS LP devices previously cleared in-K062136, K(080099, K(080822, K(082577, K(083308, K(083810 and 1(100297 are manufactured in the same material, titanium alloy (Ti-6A1-4V E… | 2006 |
| * | K080099 | Pass Spinal SystemSummary page 1…NI / MNH / KWP CFR section 888.3070 /888.3050 Device panel Orthopedic Legally marketed predicate PASS LP Spinal System (MEDICREA) =062136, K080099, K080822, devices K082577, 1083308,083810, 1(100297 ISOLA (ACROMED) = K908485… | 2008 |
| * | K080822 | VU Apod Intervertabral Body Fusion DeviceSummary page 1…/ KWP CFR section 888.3070 /888.3050 Device panel Orthopedic Legally marketed predicate PASS LP Spinal System (MEDICREA) =062136, K080099, K080822, devices K082577, 1083308,083810, 1(100297 ISOLA (ACROMED) = K908485… | 2008 |
| * | K082577 | Pass LP Spinal SystemSummary page 1….3070 /888.3050 Device panel Orthopedic Legally marketed predicate PASS LP Spinal System (MEDICREA) =062136, K080099, K080822, devices K082577, 1083308,083810, 1(100297 ISOLA (ACROMED) = K908485 SYNERGY VLS (INTERPOR… | 2008 |
| * | K083308 | Pass LP Spinal SystemSummary page 1….3050 Device panel Orthopedic Legally marketed predicate PASS LP Spinal System (MEDICREA) =062136, K080099, K080822, devices K082577, 1083308,083810, 1(100297 ISOLA (ACROMED) = K908485 SYNERGY VLS (INTERPORE CROSS I… | 2008 |
| * | K083810 | Pass LP Spinal SystemSummary page 1…evice panel Orthopedic Legally marketed predicate PASS LP Spinal System (MEDICREA) =062136, K080099, K080822, devices K082577, 1083308,083810, 1(100297 ISOLA (ACROMED) = K908485 SYNERGY VLS (INTERPORE CROSS INTL) =K… | 2009 |
| * | K100297 | Pass LP Spinal SystemSummary page 1…l Orthopedic Legally marketed predicate PASS LP Spinal System (MEDICREA) =062136, K080099, K080822, devices K082577, 1083308,083810, 1(100297 ISOLA (ACROMED) = K908485 SYNERGY VLS (INTERPORE CROSS INTL) =K012871… | 2010 |
| Kept off the family tree | K980485 | FDA’s K980485 is Isola Spinal System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1998 |
| * | K012871 | Synergy TI Integral Open Screws Models # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176…Summary page 1…K082577, 1083308,083810, 1(100297 ISOLA (ACROMED) = K908485 SYNERGY VLS (INTERPORE CROSS INTL) =K012871 MOSS MIAMI (DEPUY) = K(964024 Reason for Special 510(k) 'Additional components Submitter… | 2001 |
| * | K964024 | Depuy Motech Titanium Moss Miami Spinal SystemSummary page 1…ISOLA (ACROMED) = K908485 SYNERGY VLS (INTERPORE CROSS INTL) =K012871 MOSS MIAMI (DEPUY) = K(964024 Reason for Special 510(k) 'Additional components Submitter MEDICREA* International… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153413 | PASS LP Spinal System | 2016 | 0 |
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 27 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 49 ancestors have a recall of any class.
- Of its descendants, K153413 (Medicrea International SA, 2016) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K062136.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 pedlicle 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 br 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 pedlicle 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 br 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 L5-51 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, traumna (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordlosis), tumor, pseudoarthrosis and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112493: 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/K112493
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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