510(k) Report

510(k) · Cleared

Cleared

Isobar Spinal System

K013447510(k) TraditionalCleared Jan 15, 200290-day reviewClass II21 CFR 888.3050

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. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Jan 15, 2002 as substantially equivalent to K982990 (Sofamor Danek USA,Inc., 1998) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1998. 38 later devices descend from it.

Decided
Jan 15, 2002
Review
90 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K982990 (1998). 2 ancestors in all. 38 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2004: 1 descendant cleared2007: 1 descendant cleared2014: 2 descendants cleared2015: 3 descendants cleared2019: 3 descendants cleared2020: 3 descendants cleared2025: 7 descendants cleared2016: 3 descendants cleared2023: 6 descendants cleared2022: 2 descendants cleared2024: 6 descendants cleared2026: 1 descendant 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: 1 descendant3 generations forward: 3 descendants4 generations forward: 9 descendants5 generations forward: 10 descendants6 generations forward: 2 descendants7 generations forward: 4 descendants8 generations forward: 4 descendants9 generations forward: 3 descendants10 generations forward: 1 descendant K982990 · TSRH Spinal System · Sofamor Danek USA,Inc. · 19980+5+10
  1. Root · 1 generation backK982990 TSRH Spinal SystemSofamor Danek USA,Inc. · 1998
  2. This deviceK013447 Isobar Spinal SystemScien'Tx USA, Inc. · 2002
  3. Descendant · cites it directly · 37 of its ownK043001 MX Polyaxial Pedicle ScrewScient'X · 2004
  4. Descendant · 2 generations on · 36 of its ownK062912 Scient'x Spinal SystemScient'X · 2007
  5. Descendant · 3 generations on · 29 of its ownK133369 Tiger Spine SystemCorelink, LLC · 2014
  6. Descendant · 4 generations on · 17 of its ownK153453 Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC · 2016
  7. Descendant · 5 generations on · 13 of its ownK192121 Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

2004: 12007: 12014: 22015: 32016: 32019: 32020: 32022: 22023: 62024: 62025: 72026: 1
2004high 7 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 38 · See all
  • K043001MX Polyaxial Pedicle ScrewScient'X · 2004 · cites it directly37descendants
  • K062912Scient'x Spinal SystemScient'X · 2007 · 2 generations on36descendants
  • K133369Tiger Spine SystemCorelink, LLC · 2014 · 3 generations on29descendants
  • K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC · 2016 · 4 generations on17descendants
  • K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019 · 5 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K982990TSRH Spinal SystemSofamor Danek USA,Inc.1998—
0 (this device)K013447Isobar Spinal SystemScien'Tx USA, Inc.2002—
+1K043001MX Polyaxial Pedicle ScrewScient'X2004—
+2K062912Scient'x Spinal SystemScient'X2007—
+3K133369Tiger Spine SystemCorelink, LLC2014—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC2016—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200710
201420
201530
201630
201930
202030
202220
202360
202460
202570
202610
FIG. 1 — Lineage of K013447, 1998–2026Source: 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 KWP? 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
…dditional Components Common or usual name: Pedicle screw spinal system Classification name: Class 11 A3) 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 co…
Sofamor Danek USA,Inc.1998—
*K980485Isola Spinal System
Summary page 1
…rew spinal system Classification name: Class 11 A3) 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 membe…
Acromed Corp.1998—

Also cleared against K982990: 7 other devices →

What descends from it? (38)

See all 38

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

NumberDeviceApplicantDecidedDescendants
K043001MX Polyaxial Pedicle ScrewScient'X200437

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, K043001 (Scient'X, 2004) has gone furthest, with 37 descendants of its own.
  • 7 other devices also cite its predicate K982990.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWP

9in 2015

2007: 142008: 132009: 122010: 142011: 122012: 182013: 122014: 132015: 9
2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007: 96 days median2008: 50 days median2009: 89 days median2010: 186 days median2011: 67 days median2012: 112 days median2013: 99 days median2014: 138 days median2015: 113 days median
2007high 186 (2010) · low 50 (2008)2026

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

Recalls per year · KWP

2in 2022

2007: 22008: 12009: 232010: 22011: 62012: 12013: 32015: 12016: 32018: 12019: 22022: 2
2007high 23 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWP

494in 2025

2007: 2102008: 5942009: 6822010: 4742011: 7922012: 9182013: 1,0902014: 1,0222015: 1,3482016: 1,3792017: 8642018: 6572019: 5182020: 7962021: 5252022: 3352023: 3322024: 4362025: 494
2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, 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
200714962210
200813501594
2009128923682
2010141862474
201112676792
2012181121918
2013129931,090
20141313801,022
2015911311,348
20160—31,379
20170—0864
20180—1657
20190—2518
20200—0796
20210—0525
20220—2335
20230—0332
20240—0436
20250—0494
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 T1 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
  • K013440Isobar Spinal SystemScien'Tx USA, Inc. · 2001

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
  • K013439Anterior Cervical Plate SystemScien'Tx USA, Inc. · 2002
  • K013440Isobar Spinal SystemScien'Tx USA, Inc. · 2001
  • K013444Isobar Spinal SystemScien'Tx USA, Inc. · 2001
  • K991326Isobar Semi-Rigid Spinal SystemScien'Tx USA, Inc. · 1999

Recent decisions in KWP

The KWP category page

  • K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
  • K150753OASYS SystemStryker Corporation · 2015
  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
  • K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 20153 recalls

https://510kreport.com/device/K013447 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013447: Isobar 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/K013447

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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