510(k) · Cleared
ClearedMonarch 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 Jan 28, 2003 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. 1 of the 590 devices in its family, counting itself, has a Class I recall. 578 later devices descend from it.
- Decided
- Jan 28, 2003
- 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. 578 later devices descend from it, 10 citing it directly. 1 of the 590 devices in this family, counting this one, has a Class I recall.
- 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 deviceK024348 Monarch Spine SystemDepuyacromed · 2003
- Descendant · cites it directly · 495 of its ownK052131 Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc. · 2005
- Descendant · 2 generations on · 490 of its ownK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- Descendant · 3 generations on · 424 of its ownK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- Descendant · 3 generations on · 398 of its ownK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- Descendant · 3 generations on · 397 of its ownK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
Showing 5 of 578 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 578 · See all- K052131Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc. · 2005 · cites it directly495descendants
- K062174Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006 · 2 generations on490descendants
- K063156Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006 · 3 generations on424descendants
- K063741Expedium Spine SystemDepuy Spine, Inc. · 2007 · 3 generations on398descendants
- K080313Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008 · 3 generations on397descendants
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) | K024348 | Monarch Spine System | Depuyacromed | 2003 | — |
| +1 | K052131 | Expedium Spine System 5.5MM Commerically Pure Titanium Spinal Rods | Depuy Spine, Inc. | 2005 | — |
| +2 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| +3 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| +3 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| +3 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 6 | 0 |
| 2010 | 8 | 0 |
| 2011 | 6 | 0 |
| 2012 | 21 | 0 |
| 2013 | 25 | 0 |
| 2014 | 24 | 0 |
| 2015 | 30 | 0 |
| 2016 | 23 | 0 |
| 2017 | 34 | 0 |
| 2018 | 41 | 0 |
| 2019 | 35 | 0 |
| 2020 | 37 | 0 |
| 2021 | 30 | 1 |
| 2022 | 38 | 0 |
| 2023 | 56 | 0 |
| 2024 | 54 | 0 |
| 2025 | 51 | 0 |
| 2026 | 45 | 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.
1 device in this family has a Class I recall. 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? (578)
See all 57810 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052131 | Expedium Spine System 5.5MM Commerically Pure Titanium Spinal Rods | 2005 | 495 |
| K073126 | Expedium Spine System | 2007 | 304 |
| K063772 | Expedium Spine System | 2007 | 264 |
| K101070 | Expedium Spine System | 2010 | 260 |
| K062513 | Apex Spine System | 2006 | 179 |
| K092825 | Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw Washer | 2010 | 178 |
| K093926 | Firebird Spinal Fixation System | 2010 | 88 |
| K131250 | Tiger Spine System | 2013 | 40 |
| K091110 | Spinal Edge Titan Pedicle Screw System | 2009 | 1 |
| K191212 | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated… | 2019 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 8 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, K052131 (Depuy Spine, Inc., 2005) has gone furthest, with 495 descendants 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 Spin System ,i 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 (221 words)
The MONARCH Spin System ,i 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 (L3to 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 disk 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/K024348 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024348: Monarch Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024348
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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