510(k) · Cleared

Cleared

Pass LP Spinal System

K083308510(k) SpecialCleared Dec 10, 200830-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 · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Dec 10, 2008 as substantially equivalent to K080099 (Medicrea Technologies, 2008) after a 30-day review. Its family tree reaches back 1 generation to 2008. 135 later devices descend from it.

Decided: Dec 10, 2008
Review: 30 days
Class: Class II
Product code: MNI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K080099 (2008). 135 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK080099 Pass Spinal SystemMedicrea Technologies · 2008
This deviceK083308 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
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 135 descendants. See all descendants

Descendants cleared per year

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

Generation	Number	Device	Applicant	Decided	Recalls
−1	K080099	Pass Spinal System	Medicrea Technologies	2008	—
0 (this device)	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	—
+4	K152968	Arsenal Spinal Fixation System	Alphatec Spine, Inc.	2015	—
+5	K161363	Arsenal Spinal Fixation System	Alphatec Spine, Inc.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	2	0
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

FIG. 1 — Lineage of K083308, 2008–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K080099	Pass Spinal System Summary page 1 …et connectors are devices 'substantially equivalent to similar previously cleared PASS connecting clamps (K080099). Reason for Special 51 0(k) Product range extension and additional components Submitter MEDIC…	Medicrea Technologies	2008	—

Also cleared against K080099: 4 other devices →

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.

Number	Device	Applicant	Decided	Descendants
K110497	Pass LP Spinal System	Medicrea International	2011	133
K112493	Pass LP Spinal System	Medicrea International	2011	1

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?

Its one ancestor has no recall.
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 devices

MNI 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

2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007high 168 (2016) · low 54 (2015)2026

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

Recalls per year · MNI

1in 2018

2007high 26 (2007) · low 0 (2011)2026

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

Adverse event reports per year · MNI

80in 2025

2007high 824 (2013) · low 80 (2025)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 (135 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K083308 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083308: 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/K083308

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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