510(k) · Cleared
ClearedTitanium Mesh System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Medical L.P. · MQP Spinal Vertebral Body Replacement Device
Cleared on Feb 12, 2004 as substantially equivalent to K003275 (Synthes (Usa), 2001) and 2 other predicates after a 195-day review. Its family tree reaches back 3 generations to 1984. 26 later devices descend from it.
- Decided
- Feb 12, 2004
- Review
- 195 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K841189 (1984). 5 ancestors in all. 26 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 2 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 1 generation backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- This deviceK032371 Titanium Mesh SystemEncore Medical L.P. · 2004
- Descendant · cites it directly · 25 of its ownK070381 Theken VU Mesh VBR SystemTheken Spine, LLC · 2007
- Descendant · 2 generations on · 18 of its ownK111294 Santorini Spinal SystemK2m, Inc. · 2012
- Descendant · 3 generations on · 12 of its ownK142016 CAPRIK2m, Inc. · 2014
- Descendant · 3 generations on · 11 of its ownK170055 CAPRI Corpectomy Cage SystemK2m · 2017
- Descendant · 3 generations on · 10 of its ownK171704 CAPRI Corpectomy Cage SystemK2m · 2017
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K070381Theken VU Mesh VBR SystemTheken Spine, LLC · 2007 · cites it directly25descendants
- K111294Santorini Spinal SystemK2m, Inc. · 2012 · 2 generations on18descendants
- K142016CAPRIK2m, Inc. · 2014 · 3 generations on12descendants
- K170055CAPRI Corpectomy Cage SystemK2m · 2017 · 3 generations on11descendants
- K171704CAPRI Corpectomy Cage SystemK2m · 2017 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −2 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −1 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| 0 (this device) | K032371 | Titanium Mesh System | Encore Medical L.P. | 2004 | — |
| +1 | K070381 | Theken VU Mesh VBR System | Theken Spine, LLC | 2007 | — |
| +2 | K111294 | Santorini Spinal System | K2m, Inc. | 2012 | — |
| +3 | K142016 | CAPRI | K2m, Inc. | 2014 | — |
| +3 | K170055 | CAPRI Corpectomy Cage System | K2m | 2017 | — |
| +3 | K171704 | CAPRI Corpectomy Cage System | K2m | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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.
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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K003275 | Synthes Synmesh Spacer SystemSummary page 1…intervertebral body fixation orthosis devices PRODUCT CLASSIFICATION: Class II DEVICE PRODUCT CODE: MQP PREDICATE DEVICE: (K003275) SynMesh T M Spacer System (K003709) Surgical Dynamics TM… | 2001 |
| * | K003709 | Surgical Dynamics Mesh Cage SystemSummary page 1…T CLASSIFICATION: Class II DEVICE PRODUCT CODE: MQP PREDICATE DEVICE: (K003275) SynMesh T M Spacer System (K003709) Surgical Dynamics TM Mesh Cage System (K003043) DePuy Ac… | 2001 |
| * | K003043 | Surgical Titanium Mesh SystemSummary page 1…T M Spacer System (K003709) Surgical Dynamics TM Mesh Cage System (K003043) DePuy AcroMedT M Surgical Titanium MeshTM System DEVICE DESCRIPTION: The Ti… | 2001 |
What descends from it? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070381 | Theken VU Mesh VBR System | 2007 | 25 |
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.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K070381 (Theken Spine, LLC, 2007) has gone furthest, with 25 descendants of its own.
- 12 other devices also cite its predicate K003275.
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 Titanium Mesh System is indicated 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), to achieve anterior decompression of the spinal cord and other neutral tissues,
and to restore the height of a collapsed vertebral body. The Titanium Mesh 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032371 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032371: Titanium Mesh System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032371
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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