510(k) Report

510(k) · Cleared

Cleared

Monarch Spine System

K021335510(k) TraditionalCleared Jul 11, 200276-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Depuyacromed · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Jul 11, 2002 as substantially equivalent to K993030 (Depuyacromed, 1999) and 1 other predicate after a 76-day review. Its family tree reaches back 1 generation to 1999. 1 of the 584 devices in its family, counting itself, has a Class I recall. 581 later devices descend from it.

Decided
Jul 11, 2002
Review
76 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K993030 (1999). 2 ancestors in all. 581 later devices descend from it, 4 citing it directly. 1 of the 584 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2009: 6 descendants cleared2004: 1 descendant cleared2002: 1 descendant cleared2003: 1 descendant cleared2019: 35 descendants cleared2010: 8 descendants cleared2005: 1 descendant cleared2007: 4 descendants cleared2006: 3 descendants cleared2013: 25 descendants cleared2012: 21 descendants cleared2011: 6 descendants cleared2015: 30 descendants cleared2014: 24 descendants cleared2008: 6 descendants cleared2025: 51 descendants cleared2018: 41 descendants cleared2017: 34 descendants cleared2021: 30 descendants cleared, 1 with a Class I recall12016: 23 descendants cleared2023: 56 descendants cleared2020: 37 descendants cleared2022: 38 descendants cleared2024: 54 descendants cleared2026: 45 descendants clearedK993030 · Modification to Isola Spinal System · Depuyacromed · 19991995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 11 descendants3 generations forward: 27 descendants4 generations forward: 75 descendants5 generations forward: 99 descendants6 generations forward: 118 descendants, 1 with a Class I recall17 generations forward: 107 descendants8 generations forward: 61 descendants9 generations forward: 40 descendants10 generations forward: 27 descendants11 generations forward: 8 descendants12 generations forward: 1 descendant13 generations forward: 3 descendants K993030 · Modification to Isola Spinal System · Depuyacromed · 19990+5+10
  1. Root · 1 generation backK993030 Modification to Isola Spinal SystemDepuyacromed · 1999
  2. This deviceK021335 Monarch Spine SystemDepuyacromed · 2002
  3. Descendant · cites it directly · 578 of its ownK024348 Monarch Spine SystemDepuyacromed · 2003
  4. Descendant · 2 generations on · 495 of its ownK052131 Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc. · 2005
  5. Descendant · 3 generations on · 490 of its ownK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
  6. Descendant · 4 generations on · 424 of its ownK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
  7. Descendant · 4 generations on · 398 of its ownK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007

Showing 5 of 581 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12004: 12005: 12006: 32007: 42008: 62009: 62010: 82011: 62012: 212013: 252014: 242015: 302016: 232017: 342018: 412019: 352020: 372021: 302022: 382023: 562024: 542025: 512026: 45
2002high 56 (2023) · low 1 (2002)2026

Class I recalls in this family

  • K211616 ExcelsiusHub6 generations on · 2021

Most influential descendants

Showing 5 of 581 · See all
  • K024348Monarch Spine SystemDepuyacromed · 2003 · cites it directly578descendants
  • K052131Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc. · 2005 · 2 generations on495descendants
  • K062174Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006 · 3 generations on490descendants
  • K063156Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006 · 4 generations on424descendants
  • K063741Expedium Spine SystemDepuy Spine, Inc. · 2007 · 4 generations on398descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K993030Modification to Isola Spinal SystemDepuyacromed1999—
0 (this device)K021335Monarch Spine SystemDepuyacromed2002—
+1K024348Monarch Spine SystemDepuyacromed2003—
+2K052131Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc.2005—
+3K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006—
+4K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006—
+4K063741Expedium Spine SystemDepuy Spine, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200410
200510
200630
200740
200860
200960
201080
201160
2012210
2013250
2014240
2015300
2016230
2017340
2018410
2019350
2020370
2021301
2022380
2023560
2024540
2025510
2026450
FIG. 1 — Lineage of K021335, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K993030Modification to Isola Spinal System
Summary page 1
…CLASSIFICATION NAME: Spinal Intervertebral Body Fixation Orthosis PROPRIETARY NAME: MONARCH Spine System PREDICATE DEVICES: ISOLA Spinal System (K993030) Tri-Fix Spinal Fixation System (KO1 1830) DESCRIPTION: The MONARCH Spine System…
Depuyacromed1999—
*K011830Tri-Fix Spinal Fixation SystemEndius, Inc.2001—

Also cleared against K993030: 2 other devices →

What descends from it? (581)

See all 581

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K024348Monarch Spine SystemDepuyacromed2003578
K023438Modification to Monarch Spine SystemDepuyacromed20024
K091110Spinal Edge Titan Pedicle Screw SystemSpinal Edge, LLC20091
K033512Procyon Spinal SystemNas Medical Technologies, Inc.20040

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K024348 (Depuyacromed, 2003) has gone furthest, with 578 descendants of its own.
  • 2 other devices also cite its predicate K993030.

How does its category compare?

All MNH devices

MNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNH

8in 2016

2007: 52008: 132009: 132010: 102011: 172012: 72013: 102014: 122015: 102016: 8
2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007: 123 days median2008: 65 days median2009: 151 days median2010: 106 days median2011: 171 days median2012: 93 days median2013: 124 days median2014: 140 days median2015: 99 days median2016: 93 days median
2007high 171 (2011) · low 65 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MNH

1in 2016

2009: 72012: 12013: 12016: 1
2007high 7 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MNH

89in 2025

2007: 182008: 302009: 452010: 592011: 1072012: 4332013: 4642014: 2862015: 1522016: 2162017: 1742018: 1292019: 4032020: 4322021: 5312022: 2652023: 1212024: 3022025: 89
2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075123018
20081365030
200913151745
201010106059
2011171710107
20127931433
2013101241464
2014121400286
201510990152
20168931216
20170—0174
20180—0129
20190—0403
20200—0432
20210—0531
20220—0265
20230—0121
20240—0302
20250—089
20260—0—

What is it indicated for?

The MONARCH Spine Syster'n 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. The MONARCH Spine System when used with pedicle screws is indicated for degenerative spodylolisthesis with objective evidence of neucologic impairment, fracture, dislocation…

Read the full statement (207 words)

The MONARCH Spine Syster'n 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.

The MONARCH Spine System when used with pedicle screws is indicated for degenerative spodylolisthesis with objective evidence of neucologic 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 T I 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 as stated in the FDA summary.

Also cleared against K993030

2 other devices cite the same predicate.

  • K111410Nuvasive Long Lateral Spinal SystemNuvasive, Inc. · 2011
  • K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2010

More from Depuyacromed

48 FDA decisions under this applicant name. See the company

  • K040197Eagle Anterior Cervial Plate SystemDepuyacromed · 2004
  • K031635Depuy Acromed VBR SystemDepuyacromed · 2003
  • K030833Depuy Acromed VBR SystemDepuyacromed · 2003
  • K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
  • K030249Surgical Titanium Mesh SystemDepuyacromed · 2003

Recent decisions in MNH

The MNH category page

  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2016
  • K162143FixxSure® X-LinkInnovasis, Inc. · 2016
  • K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016
  • K162189ANAX™ 5.5 Spinal SystemU&I Corporation · 2016

https://510kreport.com/device/K021335 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021335: 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/K021335

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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