510(k) · Cleared
ClearedModification to Monarch Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuyacromed · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Nov 13, 2002 as substantially equivalent to K021335 (Depuyacromed, 2002) and 1 other predicate after a 29-day review. Its family tree reaches back 3 generations to 1995. 4 later devices descend from it.
- Decided
- Nov 13, 2002
- Review
- 29 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K944736 (1995). 11 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK944736 VSP (Variable Screw Placement)Acromed Corp. · 1995
- 2 generations backK981274 Acromed Timx Plate Based Low Back SystemAcromed Corp. · 1998
- 1 generation backK010576 Monarch Spine SystemDepuyacromed · 2001
- This deviceK023438 Modification to Monarch Spine SystemDepuyacromed · 2002
- Descendant · cites it directly · 1 of its ownK091110 Spinal Edge Titan Pedicle Screw SystemSpinal Edge, LLC · 2009
- Descendant · cites it directly · 0 of its ownK191212 CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System…Medos International SARL · 2019
- Descendant · 2 generations on · 0 of its ownK122814 Galleon Pedicle Screw SystemEverest Spine, LLC · 2012
- Descendant · cites it directly · 0 of its ownK092626 Modification to: Expedium Spine SystemDepuy Spine, Inc. · 2009
Most influential descendants
Showing 4 of 4 · See all- K091110Spinal Edge Titan Pedicle Screw SystemSpinal Edge, LLC · 2009 · cites it directly1descendant
- K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL · 2019 · cites it directly0descendants
- K122814Galleon Pedicle Screw SystemEverest Spine, LLC · 2012 · 2 generations on0descendants
- K092626Modification to: Expedium Spine SystemDepuy Spine, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944736 | VSP (Variable Screw Placement) | Acromed Corp. | 1995 | — |
| −2 | K981274 | Acromed Timx Plate Based Low Back System | Acromed Corp. | 1998 | — |
| −1 | K010576 | Monarch Spine System | Depuyacromed | 2001 | — |
| 0 (this device) | K023438 | Modification to Monarch Spine System | Depuyacromed | 2002 | — |
| +1 | K091110 | Spinal Edge Titan Pedicle Screw System | Spinal Edge, LLC | 2009 | — |
| +1 | K191212 | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM… | Medos International SARL | 2019 | — |
| +2 | K122814 | Galleon Pedicle Screw System | Everest Spine, LLC | 2012 | — |
| +1 | K092626 | Modification to: Expedium Spine System | Depuy Spine, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2019 | 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.
What descends from it? (4)
3 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 7 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K091110 (Spinal Edge, LLC, 2009) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K021335.
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 MONARCH Spine 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 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 (222 words)
The MONARCH Spine 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 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).
The MONARCH Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-Sl 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.
The MONARCH Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
The MONARCH Spine System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023438: Modification to Monarch Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023438
Report an extraction error
Are you the manufacturer?
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