510(k) Report

510(k) · Cleared

Cleared

Modification to Passmed Spinal System

K070276510(k) SpecialCleared Sep 21, 2007235-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 Sep 21, 2007 as substantially equivalent to K032094 (Medicrea, 2003) after a 235-day review. Its family tree reaches back 3 generations to 2000.

Decided
Sep 21, 2007
Review
235 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K001024 (2000). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 2 other ancestors2001: 2 other ancestorsK001024 · Pass Spinal System · Encore Orthopedics, Inc. · 2000K012175 · Pass Spinal System · Encore Orthopedics, Inc. · 2001K032094 · Passmed Spinal System · Medicrea · 200320002002200420062008
Other ancestors, by generation 2 generations back: 4 other ancestors K032094 · Passmed Spinal System · Medicrea · 2003K012175 · Pass Spinal System · Encore Orthopedics, Inc. · 2001K001024 · Pass Spinal System · Encore Orthopedics, Inc. · 20000
  1. Root · 3 generations backK001024 Pass Spinal SystemEncore Orthopedics, Inc. · 2000
  2. 2 generations backK012175 Pass Spinal SystemEncore Orthopedics, Inc. · 2001
  3. 1 generation backK032094 Passmed Spinal SystemMedicrea · 2003
  4. This deviceK070276 Modification to Passmed Spinal SystemMedicrea Technologies · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K001024Pass Spinal SystemEncore Orthopedics, Inc.2000—
−2K012175Pass Spinal SystemEncore Orthopedics, Inc.2001—
−1K032094Passmed Spinal SystemMedicrea2003—
0 (this device)K070276Modification to Passmed Spinal SystemMedicrea Technologies2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200120
200220
FIG. 1 — Lineage of K070276, 2000–2007Source: 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 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
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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
*K032094Passmed Spinal System
Summary page 1
…MNH / MNI / KWP CFR section 888.3070 / 888.3050 Device panel Orthopedic Legally marketed predicate PASSMed Spinal System (MEDICREA): K032094 devices Reason for special 510(k) Product range extension and additional components Submitter MEDICREA® T…
Medicrea2003—

Also cleared against K032094: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 7 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
  • None of the 7 ancestors has a recall.
  • 2 other devices also cite its predicate K032094.

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. 2007, this device’s year, is highlighted.

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 PASSMED is a pedicle screw 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 the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion…

Read the full statement (173 words)

The PASSMED is a pedicle screw 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 the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).

As a pedicle screw system PASSMED is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the Lb-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.

It also includes hooks and a sacral plate 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 as stated in the FDA summary.

Also cleared against K032094

2 other devices cite the same predicate.

  • K070530Modification to Passmed Spinal SystemMedicrea Technologies · 2007
  • K062136Pass 2 Spinal SystemMedicrea · 2006

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 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/K070276 · printed Nov 3, 2026

Cite this page

510(k) Report. “K070276: Modification to Passmed Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070276

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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