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 Mar 22, 1999 as substantially equivalent to K980484 (Aesculap, Inc., 1998) and 3 other predicates after a 68-day review. Its family tree reaches back 4 generations to 1990. 250 later devices descend from it.
- Decided
- Mar 22, 1999
- Review
- 68 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K901587 (1990). 25 ancestors in all. 250 later devices descend from it, 14 citing it directly.
- Root · 4 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 3 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 2 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 1 generation backK980484 Aesculap Spine System EvolutionAesculap, Inc. · 1998
- This deviceK990118 Isobar Spinal SystemScien'Tx USA, Inc. · 1999
- Descendant · cites it directly · 131 of its ownK061162 Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc. · 2006
- Descendant · 2 generations on · 130 of its ownK092624 Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 117 of its ownK100044 Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone · 2010
- Descendant · 3 generations on · 116 of its ownK122901 Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix · 2012
- Descendant · cites it directly · 94 of its ownK013444 Isobar Spinal SystemScien'Tx USA, Inc. · 2001
Showing 5 of 250 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 250 · See all- K061162Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc. · 2006 · cites it directly131descendants
- K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · 2 generations on130descendants
- K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone · 2010 · 3 generations on117descendants
- K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix · 2012 · 3 generations on116descendants
- K013444Isobar Spinal SystemScien'Tx USA, Inc. · 2001 · cites it directly94descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −3 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −2 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −1 | K980484 | Aesculap Spine System Evolution | Aesculap, Inc. | 1998 | — |
| 0 (this device) | K990118 | Isobar Spinal System | Scien'Tx USA, Inc. | 1999 | — |
| +1 | K061162 | Bar Pedicle Screw Spinal Fixation System, Model 2020 | Applied Spine Technologies, Inc. | 2006 | — |
| +2 | K092624 | Firebird Spinal Fixation System | Blackstone Medical, Inc. | 2009 | 1 |
| +3 | K100044 | Firebird Spinal Fixation System, Firebird Side-Loading Body | Blackstone | 2010 | — |
| +3 | K122901 | Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation System | Orthofix | 2012 | — |
| +1 | K013444 | Isobar Spinal System | Scien'Tx USA, Inc. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 7 | 0 |
| 2014 | 6 | 0 |
| 2015 | 9 | 0 |
| 2016 | 14 | 0 |
| 2017 | 16 | 0 |
| 2018 | 13 | 0 |
| 2019 | 14 | 0 |
| 2020 | 18 | 0 |
| 2021 | 13 | 0 |
| 2022 | 17 | 0 |
| 2023 | 23 | 0 |
| 2024 | 27 | 0 |
| 2025 | 26 | 0 |
| 2026 | 18 | 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? (4)
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 |
|---|---|---|---|
| * | K980484 | Aesculap Spine System EvolutionSummary page 1…em has similar design characteristics, i.e., material, screw size, lateral screw/rod connection, crosslinking connectors and indications, as the Spine System® Evolution (K980484/K982914), Synergy™ (K950099) and Mirage (K951846) systems distributed by Aesculap, Cross Medical and Alphatec Manufacturing, resp… | 1998 |
| * | K982914 | Aesculap Spine System Evolution: Additional ComponentsSummary page 1…imilar design characteristics, i.e., material, screw size, lateral screw/rod connection, crosslinking connectors and indications, as the Spine System® Evolution (K980484/K982914), Synergy™ (K950099) and Mirage (K951846) systems distributed by Aesculap, Cross Medical and Alphatec Manufacturing, respectively… | 1998 |
| * | K950099 | Synergy (TM) TI Posterior Spinal SystemSummary page 1…teristics, i.e., material, screw size, lateral screw/rod connection, crosslinking connectors and indications, as the Spine System® Evolution (K980484/K982914), Synergy™ (K950099) and Mirage (K951846) systems distributed by Aesculap, Cross Medical and Alphatec Manufacturing, respectively. o,… | 1997 |
| * | K951846 | Mirage Spinal System for Severe SpondylolisthesisSummary page 1…rial, screw size, lateral screw/rod connection, crosslinking connectors and indications, as the Spine System® Evolution (K980484/K982914), Synergy™ (K950099) and Mirage (K951846) systems distributed by Aesculap, Cross Medical and Alphatec Manufacturing, respectively. o, & e _,f' _/C DEPART… | 1996 |
What descends from it? (250)
See all 25014 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061162 | Bar Pedicle Screw Spinal Fixation System, Model 2020 | 2006 | 131 |
| K013444 | Isobar Spinal System | 2001 | 94 |
| K110321 | Tiger Spine System | 2011 | 83 |
| K001080 | Spine System Evolution | 2000 | 62 |
| K020245 | Modification to Isobar Spinal System | 2002 | 43 |
| K051063 | Polyaxial Hemispherical Spinal Screws | 2005 | 37 |
| K062912 | Scient'x Spinal System | 2007 | 36 |
| K121786 | Dymaxeon Spine System | 2012 | 5 |
| K061774 | Nfix II Pedicle Screw System | 2006 | 2 |
| K991326 | Isobar Semi-Rigid Spinal System | 1999 | 2 |
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 9 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- None of the 25 ancestors has a recall.
- Of its descendants, K061162 (Applied Spine Technologies, Inc., 2006) has gone furthest, with 131 descendants of its own.
- 1 other device also cites its predicate K980484.
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 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 ISOBAR 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 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.
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/K990118 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990118: 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/K990118
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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