510(k) · Cleared
ClearedMonarch Spine System Commercially Pure Titanium Spinal Rod
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 May 8, 2002 as substantially equivalent to K010576 (Depuyacromed, 2001) after a 28-day review. Its family tree reaches back 3 generations to 1995. 1 of the 505 devices in its family, counting itself, has a Class I recall. 496 later devices descend from it.
- Decided
- May 8, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K944736 (1995). 8 ancestors in all. 496 later devices descend from it, 3 citing it directly. 1 of the 505 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 deviceK021148 Monarch Spine System Commercially Pure Titanium Spinal RodDepuyacromed · 2002
- Descendant · cites it directly · 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
- Descendant · 2 generations on · 398 of its ownK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- Descendant · 2 generations on · 397 of its ownK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
Showing 5 of 496 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 496 · 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 · cites it directly490descendants
- K063156Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006 · 2 generations on424descendants
- K063741Expedium Spine SystemDepuy Spine, Inc. · 2007 · 2 generations on398descendants
- K080313Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008 · 2 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) | K021148 | Monarch Spine System Commercially Pure Titanium Spinal Rod | Depuyacromed | 2002 | — |
| +1 | 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 | — |
| +2 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 16 | 0 |
| 2013 | 20 | 0 |
| 2014 | 19 | 0 |
| 2015 | 24 | 0 |
| 2016 | 20 | 0 |
| 2017 | 27 | 0 |
| 2018 | 33 | 0 |
| 2019 | 28 | 0 |
| 2020 | 30 | 0 |
| 2021 | 26 | 1 |
| 2022 | 35 | 0 |
| 2023 | 52 | 0 |
| 2024 | 52 | 0 |
| 2025 | 47 | 0 |
| 2026 | 41 | 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? (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 |
|---|---|---|---|
| * | K010576 | Monarch Spine System | 2001 |
What descends from it? (496)
See all 4963 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 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 8 ancestors has a recall.
- Of its descendants, K052131 (Depuy Spine, Inc., 2005) has gone furthest, with 495 descendants of its own.
- 10 other devices also cite its predicate K010576.
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 when used with pedicle screws is indicated for degenerative spodylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine. The MONARCH Spine System is also indicated for pedicle screw fixation for Grade 3 and 4 spondylolisthesis at L5-S1, in skeletally mature…
Read the full statement (164 words)
The MONARCH Spine System when used with pedicle screws is indicated for
degenerative spodylolisthesis with objective evidence of neurologic impairment,
fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion
(pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.
The MONARCH Spine System is also indicated for pedicle screw fixation for
Grade 3 and 4 spondylolisthesis at L5-S1, in skeletally mature patients, utilizing
autologous bone graft, having the device fixed or attached to the lumbar or sacral
spine and intended to be removed after solid fusion is attained. Levels of
attachment for this indication range from L3 to the sacrum.
The MONARCH Spine System when not used with pedicle screws is intended for
posterior hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum.
The non-pedicle screw indications are spondylolisthesis, degenerative disc
disease (defined as discogenic back pain with degeneration of the disc confirmed
by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis),
tumor, fracture and previous failed fusion.
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/K021148 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021148: Monarch Spine System Commercially Pure Titanium Spinal Rod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021148
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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