510(k) · Cleared
ClearedMonarch Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuyacromed · MNI Orthosis, Spinal Pedicle Fixation
Cleared on May 23, 2001 as substantially equivalent to K981274 (Acromed Corp., 1998) and 4 other predicates after an 85-day review. Its family tree reaches back 2 generations to 1995. 1 of the 604 devices in its family, counting itself, has a Class I recall. 596 later devices descend from it.
- Decided
- May 23, 2001
- Review
- 85 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K944736 (1995). 7 ancestors in all. 596 later devices descend from it, 11 citing it directly. 1 of the 604 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK944736 VSP (Variable Screw Placement)Acromed Corp. · 1995
- 1 generation backK981274 Acromed Timx Plate Based Low Back SystemAcromed Corp. · 1998
- This deviceK010576 Monarch Spine SystemDepuyacromed · 2001
- Descendant · cites it directly · 578 of its ownK024348 Monarch Spine SystemDepuyacromed · 2003
- Descendant · cites it directly · 496 of its ownK021148 Monarch Spine System Commercially Pure Titanium Spinal RodDepuyacromed · 2002
- Descendant · 2 generations on · 495 of its ownK052131 Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc. · 2005
- Descendant · cites it directly · 490 of its ownK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- Descendant · 2 generations on · 424 of its ownK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
Showing 5 of 596 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 596 · See all- K024348Monarch Spine SystemDepuyacromed · 2003 · cites it directly578descendants
- K021148Monarch Spine System Commercially Pure Titanium Spinal RodDepuyacromed · 2002 · cites it directly496descendants
- K052131Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc. · 2005 · 2 generations on495descendants
- K062174Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006 · cites it directly490descendants
- K063156Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006 · 2 generations on424descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944736 | VSP (Variable Screw Placement) | Acromed Corp. | 1995 | — |
| −1 | K981274 | Acromed Timx Plate Based Low Back System | Acromed Corp. | 1998 | — |
| 0 (this device) | K010576 | Monarch Spine System | Depuyacromed | 2001 | — |
| +1 | K024348 | Monarch Spine System | Depuyacromed | 2003 | — |
| +1 | K021148 | Monarch Spine System Commercially Pure Titanium Spinal Rod | Depuyacromed | 2002 | — |
| +2 | K052131 | Expedium Spine System 5.5MM Commerically Pure Titanium Spinal Rods | Depuy Spine, Inc. | 2005 | — |
| +1 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| +2 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 7 | 0 |
| 2009 | 7 | 0 |
| 2010 | 9 | 0 |
| 2011 | 7 | 0 |
| 2012 | 21 | 0 |
| 2013 | 25 | 0 |
| 2014 | 24 | 0 |
| 2015 | 31 | 0 |
| 2016 | 24 | 0 |
| 2017 | 36 | 0 |
| 2018 | 41 | 0 |
| 2019 | 35 | 0 |
| 2020 | 38 | 0 |
| 2021 | 31 | 1 |
| 2022 | 38 | 0 |
| 2023 | 56 | 0 |
| 2024 | 54 | 0 |
| 2025 | 51 | 0 |
| 2026 | 47 | 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? (5)
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 |
|---|---|---|---|
| * | K981274 | Acromed Timx Plate Based Low Back SystemSummary page 1…mplant grade titanium alloy that conforms to ASTM standard F-136. The Monarch Spine System is substantially equivalent to the TiMX Low Back System previously cleared in K981274 and K981714, the Moss Miami Spinal System previously cleared in 510(k) K955348 and K983583, and the ISOLA System previously clear… | 1998 |
| * | K981714 | Timx Low Back System Titanium MX Rod Based Low Back SystemSummary page 1…titanium alloy that conforms to ASTM standard F-136. The Monarch Spine System is substantially equivalent to the TiMX Low Back System previously cleared in K981274 and K981714, the Moss Miami Spinal System previously cleared in 510(k) K955348 and K983583, and the ISOLA System previously cleared in 510(k)… | 1998 |
| * | K955348 | Titanium Moss Miami Spinal SystemSummary page 1…Spine System is substantially equivalent to the TiMX Low Back System previously cleared in K981274 and K981714, the Moss Miami Spinal System previously cleared in 510(k) K955348 and K983583, and the ISOLA System previously cleared in 510(k) K980485.The substantial equivalence is based upon an equivalence i… | 1996 |
| * | K983583 | Depuy Acromed Moss and Moss Miami Spinal SystemsSummary page 1…is substantially equivalent to the TiMX Low Back System previously cleared in K981274 and K981714, the Moss Miami Spinal System previously cleared in 510(k) K955348 and K983583, and the ISOLA System previously cleared in 510(k) K980485.The substantial equivalence is based upon an equivalence in design, ma… | 1998 |
| * | K980485 | Isola Spinal SystemSummary page 1…eviously cleared in K981274 and K981714, the Moss Miami Spinal System previously cleared in 510(k) K955348 and K983583, and the ISOLA System previously cleared in 510(k) K980485.The substantial equivalence is based upon an equivalence in design, materials, manufacturing methods, intended use, and relative… | 1998 |
What descends from it? (596)
See all 59611 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024348 | Monarch Spine System | 2003 | 578 |
| K021148 | Monarch Spine System Commercially Pure Titanium Spinal Rod | 2002 | 496 |
| K062174 | Modification to Expedium Spine System | 2006 | 490 |
| K013441 | Isola Polyaxial Washer | 2001 | 262 |
| K101070 | Expedium Spine System | 2010 | 260 |
| K062513 | Apex Spine System | 2006 | 179 |
| K081252 | Expedium 4.5MM Spine System | 2008 | 44 |
| K131250 | Tiger Spine System | 2013 | 40 |
| K032604 | Gii Spinal Fixation System | 2004 | 5 |
| K023438 | Modification to Monarch Spine System | 2002 | 4 |
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 6 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K024348 (Depuyacromed, 2003) has gone furthest, with 578 descendants of its own.
- 1 other device also cites its predicate K981274.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 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 (209 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-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.
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 Dual Rod Connectors can be used to connect Monarch Spine System Rods to rods of other DePuy AcroMed 4.75mm, 5.5mm, and 6.35mm diameter rod systems.
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/K010576 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010576: Monarch Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010576
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026