510(k) · Cleared
ClearedMX Polyaxial Pedicle Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scient'X · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Dec 1, 2004 as substantially equivalent to K013447 (Scien'Tx USA, Inc., 2002) and 1 other predicate after a 30-day review. Its family tree reaches back 6 generations to 1990. 37 later devices descend from it.
- Decided
- Dec 1, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K901587 (1990). 30 ancestors in all. 37 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 5 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 4 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 3 generations backK980484 Aesculap Spine System EvolutionAesculap, Inc. · 1998
- 2 generations backK990118 Isobar Spinal SystemScien'Tx USA, Inc. · 1999
- 1 generation backK020245 Modification to Isobar Spinal SystemScien'Tx USA, Inc. · 2002
- This deviceK043001 MX Polyaxial Pedicle ScrewScient'X · 2004
- Descendant · cites it directly · 36 of its ownK062912 Scient'x Spinal SystemScient'X · 2007
- Descendant · 2 generations on · 29 of its ownK133369 Tiger Spine SystemCorelink, LLC · 2014
- Descendant · 3 generations on · 17 of its ownK153453 Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC · 2016
- Descendant · 4 generations on · 13 of its ownK192121 Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019
- Descendant · 5 generations on · 12 of its ownK213935 PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K062912Scient'x Spinal SystemScient'X · 2007 · cites it directly36descendants
- K133369Tiger Spine SystemCorelink, LLC · 2014 · 2 generations on29descendants
- K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC · 2016 · 3 generations on17descendants
- K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019 · 4 generations on13descendants
- K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022 · 5 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −5 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −4 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −3 | K980484 | Aesculap Spine System Evolution | Aesculap, Inc. | 1998 | — |
| −2 | K990118 | Isobar Spinal System | Scien'Tx USA, Inc. | 1999 | — |
| −1 | K020245 | Modification to Isobar Spinal System | Scien'Tx USA, Inc. | 2002 | — |
| 0 (this device) | K043001 | MX Polyaxial Pedicle Screw | Scient'X | 2004 | — |
| +1 | K062912 | Scient'x Spinal System | Scient'X | 2007 | — |
| +2 | K133369 | Tiger Spine System | Corelink, LLC | 2014 | — |
| +3 | K153453 | Inertia Pedicle Screw and Deformity Correxxion System | Nexxt Spine, LLC | 2016 | — |
| +4 | K192121 | Black Diamond Pedicle Screw System | Osseus Fusion Systems | 2019 | — |
| +5 | K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems | 2022 | — |
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 | 4 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 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? (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 |
|---|---|---|---|
| * | K013447 | Isobar Spinal SystemSummary page 1…MNI/MNH Equivalent Device The MIX Polyaxial Pedicle Screw is a modification to the ISOBAR Polyaxial Pedicle Screw system (K(013447) and the ISOBAR Closed Pedicle Screw (K020245). It is similar in material, design, and indications. Dev… | 2002 |
| * | K020245 | Modification to Isobar Spinal SystemSummary page 1…le Screw is a modification to the ISOBAR Polyaxial Pedicle Screw system (K(013447) and the ISOBAR Closed Pedicle Screw (K020245). It is similar in material, design, and indications. Device Description The MX Polyaxial Pedicle Screw consists of pedicle scre… | 2002 |
What descends from it? (37)
See all 371 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062912 | Scient'x Spinal System | 2007 | 36 |
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 14 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- None of the 30 ancestors has a recall.
- Of its descendants, K062912 (Scient'X, 2007) has gone furthest, with 36 descendants of its own.
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 MX Polyaxial Pedicle Screw 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed…
Read the full statement (126 words)
The MX Polyaxial Pedicle Screw 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 the 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 MX Polyaxial Pedicle Screws are indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra 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 as stated in the FDA summary.
https://510kreport.com/device/K043001 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043001: MX Polyaxial Pedicle Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043001
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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