510(k) Report

510(k) · Cleared

Cleared

Surgical Dynamics Mesh Cage System

K003709510(k) TraditionalCleared Jul 18, 2001229-day reviewClass II21 CFR 888.3060

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

United States Surgical, A Division of Tyco Healthc · MQP Spinal Vertebral Body Replacement Device

Cleared on Jul 18, 2001 after a 229-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 1,715 devices in its family, counting itself, has a Class I recall. 1,714 later devices descend from it.

Decided
Jul 18, 2001
Review
229 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
0

1,714 later devices descend from it, 14 citing it directly. 1 of the 1,715 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2003: 5 descendants cleared2005: 13 descendants cleared2008: 20 descendants cleared2002: 4 descendants cleared2007: 7 descendants cleared2004: 6 descendants cleared2006: 9 descendants cleared2009: 13 descendants cleared2018: 115 descendants cleared2012: 57 descendants cleared2013: 71 descendants cleared2014: 91 descendants cleared2011: 56 descendants cleared2010: 24 descendants cleared2023: 139 descendants cleared2019: 119 descendants cleared2015: 86 descendants cleared2017: 128 descendants cleared2026: 92 descendants cleared2016: 105 descendants cleared2020: 109 descendants cleared2025: 102 descendants cleared2024: 127 descendants cleared2022: 110 descendants cleared2021: 106 descendants cleared, 1 with a Class I recall1200020052010201520202025
  1. This deviceK003709 Surgical Dynamics Mesh Cage SystemUnited States Surgical, A Division of Tyco Healthc · 2001
  2. Descendant · cites it directly · 1,440 of its ownK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  3. Descendant · 2 generations on · 1,406 of its ownK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  4. Descendant · 3 generations on · 1,405 of its ownK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  5. Descendant · cites it directly · 1,234 of its ownK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
  6. Descendant · 2 generations on · 1,224 of its ownK030833 Depuy Acromed VBR SystemDepuyacromed · 2003

Showing 5 of 1,714 descendants. See all descendants

Descendants cleared per year

2002: 42003: 52004: 62005: 132006: 92007: 72008: 202009: 132010: 242011: 562012: 572013: 712014: 912015: 862016: 1052017: 1282018: 1152019: 1192020: 1092021: 1062022: 1102023: 1392024: 1272025: 1022026: 92
2002high 139 (2023) · low 4 (2002)2026

Class I recalls in this family

  • K211616 ExcelsiusHub7 generations on · 2021

Most influential descendants

Showing 5 of 1,714 · See all
  • K042930Spacevision Cage SystemSpine Vision, Inc. · 2004 · cites it directly1,440descendants
  • K062759Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007 · 2 generations on1,406descendants
  • K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007 · 3 generations on1,405descendants
  • K020522Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002 · cites it directly1,234descendants
  • K030833Depuy Acromed VBR SystemDepuyacromed · 2003 · 2 generations on1,224descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003709Surgical Dynamics Mesh Cage SystemUnited States Surgical, A Division of Tyco Healthc2001—
+1K042930Spacevision Cage SystemSpine Vision, Inc.2004—
+2K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
+3K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
+1K020522Modification to Surgical Titanium Mesh SystemDepuyacromed2002—
+2K030833Depuy Acromed VBR SystemDepuyacromed2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200240
200350
200460
2005130
200690
200770
2008200
2009130
2010240
2011560
2012570
2013710
2014910
2015860
20161050
20171280
20181150
20191190
20201090
20211061
20221100
20231390
20241270
20251020
2026920
FIG. 1 — Lineage of K003709, 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), 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.

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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1,714)

See all 1,714

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

NumberDeviceApplicantDecidedDescendants
K042930Spacevision Cage SystemSpine Vision, Inc.20041,440
K020522Modification to Surgical Titanium Mesh SystemDepuyacromed20021,234
K030744Blackstone Surgical Titanium MeshBlackstone Medical, Inc.20031,040
K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005892
K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005829
K051454Aleutian Spacer SystemK2m, LLC2005666
K052384Lanx VBR SystemLanx, LLC2005455
K060506Stryker Spine Vlift Vertebral Body Replacement SystemStryker Spine2006270
K032371Titanium Mesh SystemEncore Medical L.P.200426
K021025Modification to Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZImplex Corp.200226

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 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K042930 (Spine Vision, Inc., 2004) has gone furthest, with 1,440 descendants of its own.

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—

More from United States Surgical, A Division of…

218 FDA decisions under this applicant name. See the company

  • K071406Autosuture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2007
  • K071920Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc · 2007
  • K061288Auto Suture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062850Autosuture Circular Eea Surgical StaplersUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062326Autosuture Modified Versaport Trocar with Fixation SleeveUnited States Surgical, A Division of Tyco Healthc · 2006

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/K003709 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003709: Surgical Dynamics Mesh Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003709

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026