510(k) · Cleared
ClearedIsobar Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scien'Tx USA, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Nov 16, 2001 as substantially equivalent to K992168 (Depuyacromed, 1999) and 1 other predicate after a 30-day review. Its family tree reaches back 5 generations to 1990. 94 later devices descend from it.
- Decided
- Nov 16, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K901587 (1990). 30 ancestors in all. 94 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 4 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 3 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 2 generations backK980484 Aesculap Spine System EvolutionAesculap, Inc. · 1998
- 1 generation backK990118 Isobar Spinal SystemScien'Tx USA, Inc. · 1999
- This deviceK013444 Isobar Spinal SystemScien'Tx USA, Inc. · 2001
- Descendant · cites it directly · 83 of its ownK110321 Tiger Spine SystemCorelink, LLC · 2011
- Descendant · 2 generations on · 81 of its ownK113058 Tiger Spine SystemCorelink, LLC · 2012
- Descendant · 2 generations on · 41 of its ownK120696 Tiger Spine SystemCorelink, LLC · 2012
- Descendant · 2 generations on · 40 of its ownK131250 Tiger Spine SystemCorelink, LLC · 2013
- Descendant · cites it directly · 36 of its ownK062912 Scient'x Spinal SystemScient'X · 2007
Showing 5 of 94 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 94 · See all- K110321Tiger Spine SystemCorelink, LLC · 2011 · cites it directly83descendants
- K113058Tiger Spine SystemCorelink, LLC · 2012 · 2 generations on81descendants
- K120696Tiger Spine SystemCorelink, LLC · 2012 · 2 generations on41descendants
- K131250Tiger Spine SystemCorelink, LLC · 2013 · 2 generations on40descendants
- K062912Scient'x Spinal SystemScient'X · 2007 · cites it directly36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −4 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −3 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −2 | K980484 | Aesculap Spine System Evolution | Aesculap, Inc. | 1998 | — |
| −1 | K990118 | Isobar Spinal System | Scien'Tx USA, Inc. | 1999 | — |
| 0 (this device) | K013444 | Isobar Spinal System | Scien'Tx USA, Inc. | 2001 | — |
| +1 | K110321 | Tiger Spine System | Corelink, LLC | 2011 | — |
| +2 | K113058 | Tiger Spine System | Corelink, LLC | 2012 | — |
| +2 | K120696 | Tiger Spine System | Corelink, LLC | 2012 | — |
| +2 | K131250 | Tiger Spine System | Corelink, LLC | 2013 | — |
| +1 | K062912 | Scient'x Spinal System | Scient'X | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 7 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 13 | 0 |
| 2024 | 16 | 0 |
| 2025 | 12 | 0 |
| 2026 | 7 | 0 |
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 MNH? 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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992168 | Moss Miami 6.35MM Polyaxial ScrewSummary page 1…Additional Components Common or usual name: Pedicle screw spinal system Classification name: Class IT 3) Legally marketed predicate device: Moss Miami Polyaxial Screw (K992168) DePuy AcroMed, Inc. ISOBAR U-Line Spinal System (K990118), Scient’x. “) Subject device description: The ISOBAR Spinal System c… | 1999 |
| * | K990118 | Isobar Spinal SystemSummary page 1…spinal system Classification name: Class IT 3) Legally marketed predicate device: Moss Miami Polyaxial Screw (K992168) DePuy AcroMed, Inc. ISOBAR U-Line Spinal System (K990118), Scient’x. “) Subject device description: The ISOBAR Spinal System consists of pedicle screws, rods, nuts, crosslink members a… | 1999 |
What descends from it? (94)
See all 946 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- None of the 30 ancestors has a recall.
- Of its descendants, K110321 (Corelink, LLC, 2011) has gone furthest, with 83 descendants of its own.
- 21 other devices also cite its predicate K992168.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 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.
https://510kreport.com/device/K013444 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013444: 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/K013444
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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