510(k) · Cleared
ClearedSurgical Titanium Mesh System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuyacromed · MQP Spinal Vertebral Body Replacement Device
Cleared on May 8, 2001 as substantially equivalent to K990148 (Depuy Motech Acromed, 1999) and 1 other predicate after a 221-day review. Its family tree reaches back 2 generations to 1984. 2 of the 1,822 devices in its family, counting itself, have a Class I recall. 1,819 later devices descend from it.
- Decided
- May 8, 2001
- Review
- 221 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K841189 (1984). 1,819 later devices descend from it, 26 citing it directly. 2 of the 1,822 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 1 generation backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- This deviceK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- Descendant · cites it directly · 1,705 of its ownK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- Descendant · 2 generations on · 1,702 of its ownK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- Descendant · 3 generations on · 1,586 of its ownK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- Descendant · 4 generations on · 1,440 of its ownK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- Descendant · 5 generations on · 1,406 of its ownK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
Showing 5 of 1,819 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 1,819 · See all- K022793Tetris Spinal ImplantSignus Medical, LLC · 2003 · cites it directly1,705descendants
- K031757Peek Tetris Spinal ImplantSignus Medical, LLC · 2003 · 2 generations on1,702descendants
- K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004 · 3 generations on1,586descendants
- K042930Spacevision Cage SystemSpine Vision, Inc. · 2004 · 4 generations on1,440descendants
- K062759Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007 · 5 generations on1,406descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −1 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| 0 (this device) | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| +1 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| +2 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| +3 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| +4 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| +5 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 5 | 0 |
| 2004 | 8 | 0 |
| 2005 | 20 | 1 |
| 2006 | 11 | 0 |
| 2007 | 14 | 0 |
| 2008 | 26 | 0 |
| 2009 | 17 | 0 |
| 2010 | 27 | 0 |
| 2011 | 66 | 0 |
| 2012 | 67 | 0 |
| 2013 | 81 | 0 |
| 2014 | 103 | 0 |
| 2015 | 93 | 0 |
| 2016 | 112 | 0 |
| 2017 | 133 | 0 |
| 2018 | 119 | 0 |
| 2019 | 123 | 0 |
| 2020 | 110 | 0 |
| 2021 | 107 | 1 |
| 2022 | 111 | 0 |
| 2023 | 142 | 0 |
| 2024 | 128 | 0 |
| 2025 | 102 | 0 |
| 2026 | 93 | 0 |
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.
2 devices in this family have 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 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990148 | Stackable Cage SystemSummary page 1…ME Implant fixation device Spinal intervertebral body fixation orthosis device PREDICATE DEVICE Stackable Cage System K990148 Rezaian Spinal Fixator K841189 INTENDED USE The Surgical Titanium Mesh System i… | 1999 |
| * | K841189 | Oec/Rezaian Spinal FixatorSummary page 1…pinal intervertebral body fixation orthosis device PREDICATE DEVICE Stackable Cage System K990148 Rezaian Spinal Fixator K841189 INTENDED USE The Surgical Titanium Mesh System is indicated for use in the thor… | 1984 |
What descends from it? (1,819)
See all 1,81926 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022793 | Tetris Spinal Implant | 2003 | 1,705 |
| K020522 | Modification to Surgical Titanium Mesh System | 2002 | 1,234 |
| K030833 | Depuy Acromed VBR System | 2003 | 1,224 |
| K042571 | Stryker Spine Avs TL Peek Spacer | 2005 | 894 |
| K050624 | Stryker Spine Avs PL Peek Spacer | 2005 | 892 |
| K051205 | Stryker Spine Avs Asl Peek Spacer | 2005 | 829 |
| K030249 | Surgical Titanium Mesh System | 2003 | 616 |
| K073649 | Bengal Stackable Cage System | 2008 | 278 |
| K060506 | Stryker Spine Vlift Vertebral Body Replacement System | 2006 | 270 |
| K121176 | STGC | 2012 | 59 |
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 15.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K022793 (Signus Medical, LLC, 2003) has gone furthest, with 1,705 descendants of its own.
- 20 other devices also cite its predicate K990148.
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The Surgical Titanium Mesh System is indicated for use in the thoracolumbar spine T1 L5 to replace a diseased vertebral body resected or excised for the treatment of tumors to achieve anterior decompression of the spinal cord and neural tissues and to restore the height of a collapsed vertebral body The Surgical Titanium Mesh System is also indicated for treating fractures of the thoracic and lumbar spine The Surgical Titanium Mesh System is designed to…
Read the full statement (163 words)
The Surgical Titanium Mesh System is indicated for use in the thoracolumbar spine T1 L5 to replace a diseased vertebral body resected or excised for the treatment of tumors to achieve anterior decompression of the spinal cord and neural tissues and to restore the height of a collapsed vertebral body
The Surgical Titanium Mesh System is also indicated for treating fractures of the thoracic and lumbar spine
The Surgical Titanium Mesh System 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 Bone graft material is recommended to be packed inside of the mesh cage prior to implantation
The Surgical Titanium Mesh System is intended for use with supplemental internal fixation The supplemental internal fixation systems that may be used with the Surgical Titanium Mesh System include DePuy AcroMed titanium plate or rod systems eg Kaneda SR University Plate M 2 ISOLA VSP Moss Miami TiMX and Profile
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K003043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003043: Surgical Titanium Mesh System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003043
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026