510(k) · Cleared
ClearedModification to Isobar 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 Feb 1, 2002 as substantially equivalent to K990118 (Scien'Tx USA, Inc., 1999) after an 8-day review. Its family tree reaches back 5 generations to 1990. 43 later devices descend from it.
- Decided
- Feb 1, 2002
- Review
- 8 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K901587 (1990). 26 ancestors in all. 43 later devices descend from it, 3 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 deviceK020245 Modification to Isobar Spinal SystemScien'Tx USA, Inc. · 2002
- Descendant · cites it directly · 38 of its ownK042964 MX Monoaxial Pedicle ScrewScient'X · 2004
- Descendant · cites it directly · 37 of its ownK043001 MX Polyaxial Pedicle ScrewScient'X · 2004
- Descendant · 2 generations on · 36 of its ownK062912 Scient'x Spinal SystemScient'X · 2007
- Descendant · 3 generations on · 29 of its ownK133369 Tiger Spine SystemCorelink, LLC · 2014
- Descendant · 4 generations on · 17 of its ownK153453 Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC · 2016
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K042964MX Monoaxial Pedicle ScrewScient'X · 2004 · cites it directly38descendants
- 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
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) | K020245 | Modification to Isobar Spinal System | Scien'Tx USA, Inc. | 2002 | — |
| +1 | K042964 | MX Monoaxial Pedicle Screw | Scient'X | 2004 | — |
| +1 | K043001 | MX Polyaxial Pedicle Screw | Scient'X | 2004 | — |
| +2 | K062912 | Scient'x Spinal System | Scient'X | 2007 | — |
| +3 | K133369 | Tiger Spine System | Corelink, LLC | 2014 | — |
| +4 | K153453 | Inertia Pedicle Screw and Deformity Correxxion System | Nexxt Spine, LLC | 2016 | — |
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 |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 6 | 0 |
| 2025 | 7 | 0 |
| 2026 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990118 | Isobar Spinal SystemSummary page 1…AR Closed Pedicle Screw Common or usual name: Pedicle screw spinal system Classification name: Class I - Legally marketed predicate device: ISOBAR U-Line Spinal System (K990118) Subject device description: The ISOBAR Spinal System consists of pedicle screws, rods, nuts and crosslink members. It can be u… | 1999 |
What descends from it? (43)
See all 433 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 12 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- None of the 26 ancestors has a recall.
- Of its descendants, K042964 (Scient'X, 2004) has gone furthest, with 38 descendants of its own.
- 13 other devices also cite its predicate K990118.
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 Closed Pedicle Screw is to be used in conjunction with the ISOBAR Spinal System, 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…
Read the full statement (204 words)
The ISOBAR Closed Pedicle Screw is to be used in conjunction with the ISOBAR Spinal System, 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/K020245 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020245: Modification to 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/K020245
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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