510(k) · Cleared
ClearedMediExpand TL Expandable VBR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cmf Medicon Surgical, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Oct 24, 2019 as substantially equivalent to K142205 (Nuvasive, Inc., 2015) and 1 other predicate after a 252-day review. Its family tree reaches back 5 generations to 1984.
- Decided
- Oct 24, 2019
- Review
- 252 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K841189 (1984). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 4 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 3 generations backK003836 Synthes Synex Spacer SystemSynthes · 2001 · Recalled
- 2 generations backK061891 Synex IISynthes Spine Co.Lp · 2006
- 1 generation backK142205 NuVasive X-CORE (R) Expandable VBR SystemNuvasive, Inc. · 2015
- This deviceK190349 MediExpand TL Expandable VBR SystemCmf Medicon Surgical, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −4 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −3 | K003836 | Synthes Synex Spacer System | Synthes | 2001 | 11 |
| −2 | K061891 | Synex II | Synthes Spine Co.Lp | 2006 | — |
| −1 | K142205 | NuVasive X-CORE (R) Expandable VBR System | Nuvasive, Inc. | 2015 | — |
| 0 (this device) | K190349 | MediExpand TL Expandable VBR System | Cmf Medicon Surgical, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | K142205 | NuVasive X-CORE (R) Expandable VBR SystemSummary page 4…Code: MQP Predicate Devices Primary Predicate Device: Nuvasive X-Core Expandable VBR System (K142205) Additional Predicate Device: Aesculap HydroLift VBR System (K083186)… | 2015 |
| * | K083186 | Aesculap Hydrolift VBR SystemSummary page 4…: Nuvasive X-Core Expandable VBR System (K142205) Additional Predicate Device: Aesculap HydroLift VBR System (K083186) K190349- Page 2 of 3… | 2010 |
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 35 years and passes through 6 companies; a new generation was cleared every 5.2 years on median.
- 2 of the 12 ancestors have a recall of any class.
- 7 other devices also cite its predicate K142205.
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 MediExpand TL Expandable VBR System is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore the height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neutral tissues. The MediExpand TL Expandable VBR System is intended to be used with supplemental internal spinal fixations systems that are cleared by the FDA for use in the thoracic and lumbar spine. 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/K190349 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190349: MediExpand TL Expandable VBR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190349
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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