510(k) Report

510(k) · Cleared

Recalled · Class III · 2020

Synthes Contoured Synmesh Spacer

K041389510(k) SpecialCleared Oct 1, 2004129-day reviewClass II21 CFR 888.3060Recalls 1

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

Synthes Spine · MQP Spinal Vertebral Body Replacement Device

Cleared on Oct 1, 2004 as substantially equivalent to K003275 (Synthes (Usa), 2001) after a 129-day review. Its family tree reaches back 1 generation to 2001. 272 later devices descend from it. It has been recalled once.

Decided
Oct 1, 2004
Review
129 days
Class
Class II
Product code
MQP
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K003275 (2001). 272 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2011: 2 descendants cleared2019: 15 descendants cleared2020: 19 descendants cleared2015: 1 descendant cleared2016: 2 descendants cleared2018: 9 descendants cleared2017: 8 descendants cleared2012: 1 descendant cleared2021: 18 descendants cleared2023: 40 descendants cleared2024: 49 descendants cleared2026: 37 descendants cleared2022: 26 descendants cleared2025: 45 descendants clearedK003275 · Synthes Synmesh Spacer System · Synthes (Usa) · 2001 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 8 descendants3 generations forward: 21 descendants4 generations forward: 51 descendants5 generations forward: 70 descendants6 generations forward: 66 descendants7 generations forward: 26 descendants8 generations forward: 16 descendants9 generations forward: 8 descendants10 generations forward: 1 descendant11 generations forward: 1 descendant K003275 · Synthes Synmesh Spacer System · Synthes (Usa) · 2001 · recalled0+5+10
  1. Root · 1 generation backK003275 Synthes Synmesh Spacer SystemSynthes (Usa) · 2001 · Recalled
  2. This deviceK041389 Synthes Contoured Synmesh SpacerSynthes Spine · 2004
  3. Descendant · cites it directly · 268 of its ownK112756 Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc. · 2011
  4. Descendant · 2 generations on · 214 of its ownK121107 Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc. · 2012
  5. Descendant · 2 generations on · 210 of its ownK143578 SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer…Globus Medical, Inc. · 2016
  6. Descendant · 2 generations on · 149 of its ownK152022 SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE®…Globus Medical, Inc. · 2017
  7. Descendant · 3 generations on · 117 of its ownK161223 TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc. · 2016

Showing 5 of 272 descendants. See all descendants

Descendants cleared per year

2011: 22012: 12015: 12016: 22017: 82018: 92019: 152020: 192021: 182022: 262023: 402024: 492025: 452026: 37
2011high 49 (2024) · low 0 (2013)2026

Most influential descendants

Showing 5 of 272 · See all
  • K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc. · 2011 · cites it directly268descendants
  • K121107Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc. · 2012 · 2 generations on214descendants
  • K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc. · 2016 · 2 generations on210descendants
  • K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc. · 2017 · 2 generations on149descendants
  • K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc. · 2016 · 3 generations on117descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003275Synthes Synmesh Spacer SystemSynthes (Usa)200114
0 (this device)K041389Synthes Contoured Synmesh SpacerSynthes Spine2004—
+1K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc.2011—
+2K121107Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc.2012—
+2K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS…Globus Medical, Inc.2016—
+2K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers…Globus Medical, Inc.2017—
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201210
201510
201620
201780
201890
2019150
2020190
2021180
2022260
2023400
2024490
2025450
2026370
FIG. 1 — Lineage of K041389, 2001–2026Source: 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.

Planning a device in MQP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MQP device

  1. #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K003275Synthes Synmesh Spacer System
Summary page 1
SYNTHES" Special 510(k): Device Modification / Line Extension fOL1j SYNTHES ® SynMesh®Spacer System-(K003275) 3.0 Premarket Notification 510 (k) Summary C004 Date Prepared: May 21, 2004 Sponsor Informa…
Synthes (Usa)200114

Also cleared against K003275: 12 other devices →

What descends from it? (272)

See all 272

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

NumberDeviceApplicantDecidedDescendants
K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc.2011268
K103320Synthes XRLSynthes Spine Co.Lp20113
K190147COLOSSEUM MeshGlobus Medical, Inc.20190
K183197PYRAMESH™ Implant SystemMedtronic Sofamor Danek USA, Inc.20190

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Sep 21, 2020Class IIIZ-0417-2021Unknown/Undetermined by firmIncorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K112756 (Globus Medical, Inc., 2011) has gone furthest, with 268 descendants of its own.
  • 12 other devices also cite its predicate K003275.

How does its category compare?

All MQP devices

MQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQP

4in 2024

2007: 302008: 172009: 112010: 62011: 82012: 72013: 32014: 52015: 82017: 92018: 62019: 82020: 32022: 12023: 12024: 42026 (partial year): 3
2007high 30 (2007) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQP

187in 2024

2007: 107 days median2008: 47 days median2009: 115 days median2010: 174 days median2011: 237 days median2012: 82 days median2013: 90 days median2014: 125 days median2015: 126 days median2017: 97 days median2018: 152 days median2019: 93 days median2020: 103 days median2024: 187 days median2026 (partial year): 102 days median
2007high 237 (2011) · low 47 (2008)2026

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

Recalls per year · MQP

1in 2022

2007: 22009: 142010: 22011: 12012: 22020: 152022: 1
2007high 15 (2020) · low 0 (2008)2026

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

Adverse event reports per year · MQP

168in 2025

2007: 612008: 762009: 1112010: 1662011: 1212012: 1412013: 2072014: 2162015: 2582016: 1292017: 1412018: 1302019: 1172020: 1572021: 2082022: 1372023: 712024: 982025: 168
2007high 258 (2015) · low 61 (2007)2025

MAUDE reports naming product code MQP, 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
200730107261
20081747076
20091111514111
201061742166
201182371121
20127822141
20133900207
201451250216
201581260258
20160—0129
20179970141
201861520130
20198930117
2020310315157
20210—0208
20221—1137
20231—071
20244187098
20250—0168
202631020—

What is it indicated for?

SYNTHES® Contoured SynMesh® Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The SYNTHES® Contoured SynMesh® Spacer is intended to be used with SYNTHES®' supplemental internal fixation systems, e.g., ATLP, Ventrofix, TSLP, and USS, Dual Opening USS, Small Stature USS, and Click'X. The interior of the spacer component of the SYNTHES® SynMesh® Spacer can be packed with bone.

SYNTHES® Contoured SynMesh® Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Indications for use as stated in the FDA summary.

Also cleared against K003275

12 other devices cite the same predicate.

  • K183054SYNMESH SystemDepuy Synthes Spine · 2019
  • K121176STGCCardinal Spine, LLC · 2012
  • K103320Synthes XRLSynthes Spine Co.Lp · 20111 recall
  • K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc. · 2011
  • K070381Theken VU Mesh VBR SystemTheken Spine, LLC · 2007
  • K061578SSP Vertebral Body ReplacementSpecialty Spine Products, LLC · 2006

More from Synthes Spine

36 FDA decisions under this applicant name. See the company

  • K122211Synthes Navigable Pedicle Preparation InstrumentsSynthes Spine · 2012
  • K120838Synthes Matrix SystemSynthes Spine · 2012
  • K111048Synthes Scout Tack FixationSynthes Spine · 2012
  • K120928Synthes Matrix SystemSynthes Spine · 2012
  • K120571Synthes Uss ConnectorSynthes Spine · 2012

Recent decisions in MQP

The MQP category page

  • K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group · 2026
  • K261031Poseidon STSignus Medinzintechnik GmbH · 2026
  • K253158VyBrate™ VBR SystemVy Spine, LLC · 2026
  • K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024
  • K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024

https://510kreport.com/device/K041389 · printed Nov 4, 2026

Cite this page

510(k) Report. “K041389: Synthes Contoured Synmesh Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041389

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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