510(k) Report

510(k) · Cleared

Cleared

Pass Spinal System

K013431510(k) SpecialCleared Nov 15, 200130-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

Encore Orthopedics, Inc. · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Nov 15, 2001 as substantially equivalent to K001024 (Encore Orthopedics, Inc., 2000) after a 30-day review. Its family tree reaches back 1 generation to 2000. 150 later devices descend from it.

Decided
Nov 15, 2001
Review
30 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K001024 (2000). 150 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2006: 1 descendant cleared2007: 2 descendants cleared2011: 2 descendants cleared2013: 4 descendants cleared2019: 3 descendants cleared2016: 7 descendants cleared2015: 5 descendants cleared2022: 13 descendants cleared2014: 1 descendant cleared2017: 8 descendants cleared2018: 8 descendants cleared2020: 6 descendants cleared2023: 15 descendants cleared2026: 25 descendants cleared2021: 6 descendants cleared2024: 19 descendants cleared2025: 24 descendants clearedReference device: K012175 · Pass Spinal System · Encore Orthopedics, Inc. · 2001K001024 · Pass Spinal System · Encore Orthopedics, Inc. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 4 descendants5 generations forward: 10 descendants6 generations forward: 13 descendants7 generations forward: 30 descendants8 generations forward: 23 descendants9 generations forward: 14 descendants10 generations forward: 16 descendants11 generations forward: 17 descendants12 generations forward: 14 descendants13 generations forward: 1 descendant K001024 · Pass Spinal System · Encore Orthopedics, Inc. · 20000+5+10
  1. Root · 1 generation backK001024 Pass Spinal SystemEncore Orthopedics, Inc. · 2000
  2. This deviceK013431 Pass Spinal SystemEncore Orthopedics, Inc. · 2001
  3. Descendant · cites it directly · 149 of its ownK032094 Passmed Spinal SystemMedicrea · 2003
  4. Descendant · 2 generations on · 146 of its ownK062136 Pass 2 Spinal SystemMedicrea · 2006
  5. Descendant · 3 generations on · 133 of its ownK110497 Pass LP Spinal SystemMedicrea International · 2011 · Recalled
  6. Descendant · 4 generations on · 132 of its ownK123138 Pass LP Spinal SystemMedicrea International · 2013
  7. Descendant · 5 generations on · 84 of its ownK142798 PASS LP Spinal SystemMedicrea International SA · 2015

Showing 5 of 150 descendants. See all descendants

Descendants cleared per year

2003: 12006: 12007: 22011: 22013: 42014: 12015: 52016: 72017: 82018: 82019: 32020: 62021: 62022: 132023: 152024: 192025: 242026: 25
2003high 25 (2026) · low 0 (2004)2026

Most influential descendants

Showing 5 of 150 · See all
  • K032094Passmed Spinal SystemMedicrea · 2003 · cites it directly149descendants
  • K062136Pass 2 Spinal SystemMedicrea · 2006 · 2 generations on146descendants
  • K110497Pass LP Spinal SystemMedicrea International · 2011 · 3 generations on133descendants
  • K123138Pass LP Spinal SystemMedicrea International · 2013 · 4 generations on132descendants
  • K142798PASS LP Spinal SystemMedicrea International SA · 2015 · 5 generations on84descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K001024Pass Spinal SystemEncore Orthopedics, Inc.2000—
0 (this device)K013431Pass Spinal SystemEncore Orthopedics, Inc.2001—
+1K032094Passmed Spinal SystemMedicrea2003—
+2K062136Pass 2 Spinal SystemMedicrea2006—
+3K110497Pass LP Spinal SystemMedicrea International20111
+4K123138Pass LP Spinal SystemMedicrea International2013—
+5K142798PASS LP Spinal SystemMedicrea International SA2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200610
200720
201120
201340
201410
201550
201670
201780
201880
201930
202060
202160
2022130
2023150
2024190
2025240
2026250
FIG. 1 — Lineage of K013431, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 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.

TypeNumberDeviceApplicantDecidedRecalls
*K001024Pass Spinal System
Summary page 1
…on or usual name: Pedicle screw spinal system Spinal interlaminal fixation orthosis Classification name: Class Il Legally marketed predicate device: PASS Spinal System (K001024) Subject device description: The subjects of this Special 510(k) submission are the addition of polyaxial crosslink components f…
Encore Orthopedics, Inc.2000—
†K012175Pass Spinal SystemEncore Orthopedics, Inc.2001—

Also cleared against K001024: 5 other devices →

What descends from it? (150)

See all 150

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K032094Passmed Spinal SystemMedicrea2003149

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, K032094 (Medicrea, 2003) has gone furthest, with 149 descendants of its own.
  • 5 other devices also cite its predicate K001024.

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.

FDA decisions per year · MNI

1in 2017

2007: 202008: 232009: 182010: 162011: 172012: 192013: 142014: 62015: 122016: 72017: 1
2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007: 82 days median2008: 64 days median2009: 86 days median2010: 74 days median2011: 111 days median2012: 75 days median2013: 77 days median2014: 104 days median2015: 54 days median2016: 168 days median
2007high 168 (2016) · low 54 (2015)2026

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

Recalls per year · MNI

1in 2018

2007: 262008: 82009: 32010: 12012: 12013: 42015: 12018: 1
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

2007: 832008: 1082009: 1382010: 1262011: 1462012: 2002013: 8242014: 3012015: 2602016: 1172017: 2472018: 1342019: 1882020: 1152021: 2702022: 2142023: 1222024: 1142025: 80
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200720822683
200823648108
200918863138
201016741126
2011171110146
201219751200
201314774824
201461040301
201512541260
201671680117
20171—0247
20180—1134
20190—0188
20200—0115
20210—0270
20220—0214
20230—0122
20240—0114
20250—080
20260—0—

What is it indicated for?

The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized 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, scoliosis, kyphosis…

Read the full statement (127 words)

The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized 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, scoliosis, kyphosis, spinal tumor, and failed previous fusion

(pseudarthrosis).

As a pedicle screw system, the PASS Spinal System is intended 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K001024

5 other devices cite the same predicate.

  • K032094Passmed Spinal SystemMedicrea · 2003
  • K020236Modification to Pass Spinal SystemEncore Orthopedics, Inc. · 2002
  • K013442Pass Spinal SystemEncore Orthopedics, Inc. · 2002
  • K013191Pass Spinal SystemEncore Orthopedics, Inc. · 2001
  • K012175Pass Spinal SystemEncore Orthopedics, Inc. · 2001

More from Encore Orthopedics, Inc.

85 FDA decisions under this applicant name. See the company

  • K0329053DKNEE Porous Coated Femoral ComponentEncore Orthopedics, Inc. · 2004
  • K0201143D KNEEEncore Orthopedics, Inc. · 20025 recalls
  • K020741Unicondylar KneeEncore Orthopedics, Inc. · 20022 recalls
  • K020236Modification to Pass Spinal SystemEncore Orthopedics, Inc. · 2002
  • K020170Keystone Hip System Calcar Replacement Body and Build UPEncore Orthopedics, Inc. · 2002

Recent decisions in MNI

The MNI category page

  • K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017
  • K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016
  • K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc. · 2016
  • K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016
  • K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2016

https://510kreport.com/device/K013431 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013431: Pass Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013431

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026