510(k) · Cleared
ClearedPYRAMESH™ Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Apr 4, 2019 as substantially equivalent to K011406 (Medtronic Sofamor Danek, Inc., 2001) and 3 other predicates after a 136-day review. Its family tree reaches back 11 generations to 2001.
- Decided
- Apr 4, 2019
- Review
- 136 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K003155 (2001). 23 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.
- Root · 11 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 7 generations between
- 3 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 2 generations backK063491 T2 Sceptor Spinal SystemMedtronic Sofamor Danek · 2007
- 1 generation backK091883 T2 Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009
- This deviceK183197 PYRAMESH™ Implant SystemMedtronic Sofamor Danek USA, Inc. · 2019
Show all 11 generations
- Root · 11 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 10 generations backK012254 VBROsteotech, Inc. · 2001
- 9 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 8 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 7 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 6 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 5 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 4 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 3 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 2 generations backK063491 T2 Sceptor Spinal SystemMedtronic Sofamor Danek · 2007
- 1 generation backK091883 T2 Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009
- This deviceK183197 PYRAMESH™ Implant SystemMedtronic Sofamor Danek USA, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −10 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −9 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −8 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −7 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −6 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −5 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −4 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −3 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −2 | K063491 | T2 Sceptor Spinal System | Medtronic Sofamor Danek | 2007 | — |
| −1 | K091883 | T2 Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | — |
| 0 (this device) | K183197 | PYRAMESH™ Implant System | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K011406 | Spinal Mesh SystemSummary page 4…Predicate Devices: Primary Predicate SPINAL™ Mesh System Predicate 1: K011406 (S.E. 12/27/2001) Additional Predicates: T2 S… | 2001 |
| * | K091883 | T2 Spinal SystemSummary page 4…Additional Predicates: T2 Spinal System Predicate 2: K091883 (S.E. 09/21/2009) VERTE-STACK™ Spinal System… | 2009 |
| * | K052931 | Modification to Verte-Stack Spinal SystemSummary page 4…Predicate 2: K091883 (S.E. 09/21/2009) VERTE-STACK™ Spinal System Predicate 3: K052931(S.E. 11/16/2005) Page 1… | 2005 |
| * | K041389 | Synthes Contoured Synmesh SpacerSummary page 5…3197 – 510(k) Summary SynMesh System Predicate 4: K041389 (S.E. 10/01/2004) The predicates have not been subject to a design related recall. IV. Description:… | 2004 |
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 18 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 2 of the 23 ancestors have a recall of any class.
- 2 other devices also cite its predicate K011406.
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. 2019, this device’s year, is highlighted.
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 PYRAMESH™ implants are for use in the thoracolumbar spine (T1 to L5) to replace and restore the height of a diseased or damaged vertebral body caused by tumor and/or fracture. When used for Spinal Indications PYRAMESH™ implants is intended to be used with supplemental fixation. Allograft or autograft material may be used at the surgeon's discretion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183197: PYRAMESH™ Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183197
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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