510(k) Report

510(k) · Cleared

Cleared

Titanium Mesh Implant

K041407510(k) TraditionalCleared Dec 29, 2004216-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

Interpore Cross Intl. · MQP Spinal Vertebral Body Replacement Device

Cleared on Dec 29, 2004 as substantially equivalent to K003043 (Depuyacromed, 2001) and 1 other predicate after a 216-day review. Its family tree reaches back 4 generations to 1984.

Decided
Dec 29, 2004
Review
216 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K841189 (1984). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestorK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K020522 · Modification to Surgical Titanium Mesh System · Depuyacromed · 2002198019851990199520002005
Other ancestors, by generation 2 generations back: 1 other ancestor K020522 · Modification to Surgical Titanium Mesh System · Depuyacromed · 2002K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 19840
  1. Root · 4 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 3 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 2 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 1 generation backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
  5. This deviceK041407 Titanium Mesh ImplantInterpore Cross Intl. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−3K990148Stackable Cage SystemDepuy Motech Acromed1999—
−2K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−1K020522Modification to Surgical Titanium Mesh SystemDepuyacromed2002—
0 (this device)K041407Titanium Mesh ImplantInterpore Cross Intl.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
FIG. 1 — Lineage of K041407, 1984–2004Source: 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? (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
*K003043Surgical Titanium Mesh System
Summary page 1
…cement Product Classification: Class LI lProduct Code: MQP Proprietary Name: Titanium Mesh Implant PREDICATE DEVICE DePuy Acromed Surgical Titanium Mesh (K003043 and K020522) INTENDED USE The Titanium Mesh Implant is indicated for use in the thoracolunibar spine (Ti to L5) for total replac…
Depuyacromed2001—
*K020522Modification to Surgical Titanium Mesh System
Summary page 1
…ct Classification: Class LI lProduct Code: MQP Proprietary Name: Titanium Mesh Implant PREDICATE DEVICE DePuy Acromed Surgical Titanium Mesh (K003043 and K020522) INTENDED USE The Titanium Mesh Implant is indicated for use in the thoracolunibar spine (Ti to L5) for total replacement of dis…
Depuyacromed2002—

Also cleared against K003043: 25 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
  • None of the 5 ancestors has a recall.
  • 25 other devices also cite its predicate K003043.

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?

The Titanium Mesh Implant is indicated for use in the thoracolumbar spine (i.e., TI to LS) for total replacement of diseased vertebral body(ies) resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Titanium Mesh Implant is also indicated for total vertebral body replacement for the treatment of fractures of the…

Read the full statement (148 words)

The Titanium Mesh Implant is indicated for use in the thoracolumbar spine (i.e., TI to LS) for total replacement of diseased vertebral body(ies) resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Titanium Mesh Implant is also indicated for total vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The Titanium Mesh Implant is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

The Titanium Mesh Implant is intended to be used with supplemental internal fixation. The supplemental fixation system that must be used with this implant is tile Synergy Spinal System. In addition, the Titanium Mesh Implant is intended for use with bone graft.

Indications for use as stated in the FDA summary.

Also cleared against K003043

25 other devices cite the same predicate.

  • K181921Solidity Vertebral Body ReplacementUlrich Medical USA · 2018
  • K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh…Medos International SARL · 2018
  • K171704CAPRI Corpectomy Cage SystemK2m · 2017
  • K142212Pyrenees Cervical Plate SystemK2m, Inc. · 2015
  • K142030STGC-LordoticCardinal Spine, LLC · 2015
  • K142016CAPRIK2m, Inc. · 2014

More from Interpore Cross Intl.

39 FDA decisions under this applicant name. See the company

  • K050861Peek CasInterpore Cross Intl. · 2005
  • K031399Intergro DBMInterpore Cross Intl. · 20051 recall
  • K043229Modification to Altius Oct SystemInterpore Cross Intl. · 2004
  • K042798C-Tek C-Trun Anterior Cervical Plate SystemInterpore Cross Intl. · 2004
  • K040928Expandable Peek VBR ImplantInterpore Cross Intl. · 2004

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/K041407 · printed Nov 4, 2026

Cite this page

510(k) Report. “K041407: Titanium Mesh Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041407

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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