510(k) Report

510(k) · Cleared

Cleared

Isobar Spinal System

K013440510(k) SpecialCleared Nov 16, 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

Scien'Tx USA, Inc. · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Nov 16, 2001 as substantially equivalent to K982990 (Sofamor Danek USA,Inc., 1998) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 1998. 84 later devices descend from it.

Decided
Nov 16, 2001
Review
30 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K982990 (1998). 2 ancestors in all. 84 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2015: 1 descendant cleared2018: 5 descendants cleared2019: 1 descendant cleared2017: 6 descendants cleared2016: 1 descendant cleared2024: 15 descendants cleared2020: 5 descendants cleared2021: 2 descendants cleared2022: 7 descendants cleared2026: 15 descendants cleared2025: 16 descendants cleared2023: 10 descendants clearedK982990 · TSRH Spinal System · Sofamor Danek USA,Inc. · 19981995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 9 descendants3 generations forward: 14 descendants4 generations forward: 9 descendants5 generations forward: 13 descendants6 generations forward: 20 descendants7 generations forward: 17 descendants8 generations forward: 1 descendant K982990 · TSRH Spinal System · Sofamor Danek USA,Inc. · 19980+5
  1. Root · 1 generation backK982990 TSRH Spinal SystemSofamor Danek USA,Inc. · 1998
  2. This deviceK013440 Isobar Spinal SystemScien'Tx USA, Inc. · 2001
  3. Descendant · cites it directly · 83 of its ownK152968 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
  4. Descendant · 2 generations on · 75 of its ownK161363 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2016
  5. Descendant · 2 generations on · 70 of its ownK181677 Kodiak Spinal Fixation SystemAlphatec Spine, Inc. · 2018
  6. Descendant · 2 generations on · 69 of its ownK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
  7. Descendant · 3 generations on · 61 of its ownK203056 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020

Showing 5 of 84 descendants. See all descendants

Descendants cleared per year

2015: 12016: 12017: 62018: 52019: 12020: 52021: 22022: 72023: 102024: 152025: 162026: 15
2015high 16 (2025) · low 1 (2015)2026

Most influential descendants

Showing 5 of 84 · See all
  • K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015 · cites it directly83descendants
  • K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2016 · 2 generations on75descendants
  • K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc. · 2018 · 2 generations on70descendants
  • K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019 · 2 generations on69descendants
  • K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · 3 generations on61descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K982990TSRH Spinal SystemSofamor Danek USA,Inc.1998—
0 (this device)K013440Isobar Spinal SystemScien'Tx USA, Inc.2001—
+1K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.2015—
+2K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.2016—
+2K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.2018—
+2K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.2019—
+3K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
201760
201850
201910
202050
202120
202270
2023100
2024150
2025160
2026150
FIG. 1 — Lineage of K013440, 1998–2026Source: 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? (2)

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
*K982990TSRH Spinal System
Summary page 1
…em Additional Components Common or usual name: Pedicle screw spinal system Classification name: Class I Legally marketed predicate device: TSRH™ Spinal Implant System (K982990) Sofamor Danek and the ISOLA® Spinal System (K980485) DePuy AcroMed. Subject device description: The ISOBAR Spinal System consi…
Sofamor Danek USA,Inc.1998—
*K980485Isola Spinal System
Summary page 1
…e screw spinal system Classification name: Class I Legally marketed predicate device: TSRH™ Spinal Implant System (K982990) Sofamor Danek and the ISOLA® Spinal System (K980485) DePuy AcroMed. Subject device description: The ISOBAR Spinal System consists of pedicle screws, rods, nuts, crosslink members…
Acromed Corp.1998—

Also cleared against K982990: 7 other devices →

What descends from it? (84)

See all 84

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

NumberDeviceApplicantDecidedDescendants
K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K152968 (Alphatec Spine, Inc., 2015) has gone furthest, with 83 descendants of its own.
  • 7 other devices also cite its predicate K982990.

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 ISOBAR Spinal System 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous…

Read the full statement (193 words)

The ISOBAR Spinal System 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 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 ISOBAR 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.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the ISOBAR Spinal

System is intended for hook fixation from Tl to the ilium/sacrum. The non-pedicle screw

indications are spondylolisthesis, degenerative disc disease (as defined by back pain of

discogenic origin with degeneration of the disc confirmed by history patient history and

radiographic studies), deformities (scoliosis, kyphosis and lordosis), tumor, pseudoarthrosis,

trauma (fracture or dislocation) and/or previous failed fusion surgery.

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 K982990

7 other devices cite the same predicate.

  • K110676TSRH Spinal SystemMedtronic Sofamor Danek · 2011
  • K093058TSRH Spinal SystemMedtronic Sofamor Danek, Inc. · 2009
  • K072317Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc. · 20074 recalls
  • K030087Spinal Concepts, Inc. Bacfix TI Spinal SystemSpinal Concepts, Inc. · 2003
  • K020356Alpha Mirage Top Tightening Spinal SystemAlphatec Mfg., Inc. · 2002
  • K013447Isobar Spinal SystemScien'Tx USA, Inc. · 2002

More from Scien'Tx USA, Inc.

8 FDA decisions under this applicant name. See the company

  • K020245Modification to Isobar Spinal SystemScien'Tx USA, Inc. · 2002
  • K013447Isobar Spinal SystemScien'Tx USA, Inc. · 2002
  • K013439Anterior Cervical Plate SystemScien'Tx USA, Inc. · 2002
  • K013444Isobar Spinal SystemScien'Tx USA, Inc. · 2001
  • K991326Isobar Semi-Rigid Spinal SystemScien'Tx USA, Inc. · 1999

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/K013440 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013440: Isobar Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013440

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