510(k) Report

510(k) · Cleared

Cleared

Pass LP Spinal System

K082577510(k) SpecialCleared Oct 3, 200828-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medicrea Technologies · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Oct 3, 2008 after a 28-day review. The FDA summary names its predicate without a number. 135 later devices descend from it.

Decided
Oct 3, 2008
Review
28 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
0

135 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2011: 2 descendants cleared2013: 3 descendants cleared2016: 4 descendants cleared2015: 4 descendants cleared2014: 1 descendant cleared2018: 8 descendants cleared2020: 6 descendants cleared2022: 12 descendants cleared2023: 14 descendants cleared2026: 24 descendants cleared2019: 2 descendants cleared2017: 7 descendants cleared2024: 19 descendants cleared2021: 5 descendants cleared2025: 24 descendants cleared20052010201520202025
  1. This deviceK082577 Pass LP Spinal SystemMedicrea Technologies · 2008
  2. Descendant · cites it directly · 133 of its ownK110497 Pass LP Spinal SystemMedicrea International · 2011 · Recalled
  3. Descendant · 2 generations on · 132 of its ownK123138 Pass LP Spinal SystemMedicrea International · 2013
  4. Descendant · 3 generations on · 84 of its ownK142798 PASS LP Spinal SystemMedicrea International SA · 2015
  5. Descendant · 4 generations on · 83 of its ownK152968 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
  6. Descendant · 5 generations on · 75 of its ownK161363 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2016

Showing 5 of 135 descendants. See all descendants

Descendants cleared per year

2011: 22013: 32014: 12015: 42016: 42017: 72018: 82019: 22020: 62021: 52022: 122023: 142024: 192025: 242026: 24
2011high 24 (2025) · low 0 (2012)2026

Most influential descendants

Showing 5 of 135 · 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K082577Pass LP Spinal SystemMedicrea Technologies2008—
+1K110497Pass LP Spinal SystemMedicrea International20111
+2K123138Pass LP Spinal SystemMedicrea International2013—
+3K142798PASS LP Spinal SystemMedicrea International SA2015—
+4K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.2015—
+5K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201330
201410
201540
201640
201770
201880
201920
202060
202150
2022120
2023140
2024190
2025240
2026240
FIG. 1 — Lineage of K082577, 2008–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*—similar devices previously cleared lumbar intervertebral body fusion devices
Named without a submission number
—

What descends from it? (135)

See all 135

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K110497Pass LP Spinal SystemMedicrea International2011133
K112493Pass LP Spinal SystemMedicrea International20111

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 MNH devices

MNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · MNH

8in 2016

2007: 52008: 132009: 132010: 102011: 172012: 72013: 102014: 122015: 102016: 8
2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007: 123 days median2008: 65 days median2009: 151 days median2010: 106 days median2011: 171 days median2012: 93 days median2013: 124 days median2014: 140 days median2015: 99 days median2016: 93 days median
2007high 171 (2011) · low 65 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MNH

1in 2016

2009: 72012: 12013: 12016: 1
2007high 7 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MNH

89in 2025

2007: 182008: 302009: 452010: 592011: 1072012: 4332013: 4642014: 2862015: 1522016: 2162017: 1742018: 1292019: 4032020: 4322021: 5312022: 2652023: 1212024: 3022025: 89
2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075123018
20081365030
200913151745
201010106059
2011171710107
20127931433
2013101241464
2014121400286
201510990152
20168931216
20170—0174
20180—0129
20190—0403
20200—0432
20210—0531
20220—0265
20230—0121
20240—0302
20250—089
20260—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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, spinal deformations such as scoliosis or kyphosis…

Read the full statement (133 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, spinal deformations such as scoliosis or kyphosis, loss of stability due to tumors, and failed previous fusion (pseudoarthrosis).

The PASS LP Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra 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.

More from Medicrea Technologies

14 FDA decisions under this applicant name. See the company

  • K102406Pass Anterior Spinal SystemMedicrea Technologies · 2011
  • K100544Impix Lumbar Interbody DeviceMedicrea Technologies · 20101 recall
  • K083798Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar IbfMedicrea Technologies · 20102 recalls
  • K100297Pass LP Spinal SystemMedicrea Technologies · 2010
  • K083810Pass LP Spinal SystemMedicrea Technologies · 2009

Recent decisions in MNH

The MNH category page

  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2016
  • K162143FixxSure® X-LinkInnovasis, Inc. · 2016
  • K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016
  • K162189ANAX™ 5.5 Spinal SystemU&I Corporation · 2016

https://510kreport.com/device/K082577 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082577: 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/K082577

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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