510(k) Report

510(k) · Cleared

Cleared

Atalia Titanium Surgical Mesh

K041798510(k) TraditionalCleared Feb 7, 2005220-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

Us Spinal Technologies, LLC · MQP Spinal Vertebral Body Replacement Device

Cleared on Feb 7, 2005 as substantially equivalent to K003155 (Osteotech, Inc., 2001) and 2 other predicates after a 220-day review. Its family tree reaches back 3 generations to 1984.

Decided
Feb 7, 2005
Review
220 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K841189 (1984). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestor2001: 3 other ancestorsK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001198019851990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 19840
  1. Root · 3 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 2 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 1 generation backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. This deviceK041798 Atalia Titanium Surgical MeshUs Spinal Technologies, LLC · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−2K990148Stackable Cage SystemDepuy Motech Acromed1999—
−1K003043Surgical Titanium Mesh SystemDepuyacromed2001—
0 (this device)K041798Atalia Titanium Surgical MeshUs Spinal Technologies, LLC2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200130
200310
FIG. 1 — Lineage of K041798, 1984–2005Source: 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? (3)

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
*K003155Vertebral Body Replacement
Summary page 1
…SUBSTANTIALLY EQUIVALENT TO: The Atalia Titanium Surgical Mesh is substantially equivalent to various features and performance characteristics to the Osteotech VBR (K003 155), the Depuy Acronied Surgical Titanium Mesh (K003043) and the Blackstone Surgical Mesh System (K030744) as detailed in the submi…
Osteotech, Inc.2001—
*K003043Surgical Titanium Mesh System
Summary page 1
…urgical Mesh is substantially equivalent to various features and performance characteristics to the Osteotech VBR (K003 155), the Depuy Acronied Surgical Titanium Mesh (K003043) and the Blackstone Surgical Mesh System (K030744) as detailed in the submission. DESCRIPTION of the DEVICE: The Atalia Titaniu…
Depuyacromed2001—
*K030744Blackstone Surgical Titanium Mesh
Summary page 1
…features and performance characteristics to the Osteotech VBR (K003 155), the Depuy Acronied Surgical Titanium Mesh (K003043) and the Blackstone Surgical Mesh System (K030744) as detailed in the submission. DESCRIPTION of the DEVICE: The Atalia Titanium Surgical Mesh is a round-patterned, surgical mesh…
Blackstone Medical, Inc.2003—

Also cleared against K003155: 6 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 21 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
  • 1 of the 7 ancestors has a recall of any class.
  • 6 other devices also cite its predicate K003155.

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 Atalia Titanium Surgical Mesh is indicated for use in the thoraco-lumbar spine (TI-L5), in cases where one vertebral body has been structurally compromised either by tumor or trauma. The objective is the restoration of anterior column support through introduction of a corpectomy construct in tandem with bone graft to ultimately realize spinal fusion. The Atalia Titanium Surgical Mesh is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and/or lumbar spine.

Indications for use as stated in the FDA summary.

Also cleared against K003155

6 other devices cite the same predicate.

  • K181921Solidity Vertebral Body ReplacementUlrich Medical USA · 2018
  • K111294Santorini Spinal SystemK2m, Inc. · 2012
  • K070786X-Pod Adjustable Vertebral Body ReplacementTheken Spine, LLC · 2007
  • K070181Sintea Biotech DSC/Alf Spinal System, DSC.XX.T5.XX, Alf.XX.T5.XXSintea Biotech, Inc. · 2007
  • K050058Theken Reveal VBR SystemTheken Surgical,Llc · 2005
  • K012254VBROsteotech, Inc. · 2001

More from Us Spinal Technologies, LLC

2 FDA decisions under this applicant name. See the company

  • K041625LTD Polyaxial Fixation SystemUs Spinal Technologies, LLC · 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/K041798 · printed Nov 4, 2026

Cite this page

510(k) Report. “K041798: Atalia Titanium Surgical Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041798

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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