510(k) · Cleared
ClearedCO Vertebral Body Replacement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scient'X · MQP Spinal Vertebral Body Replacement Device
Cleared on May 27, 2005 as substantially equivalent to K033109 (Scient'X, 2004) after a 105-day review. Its family tree reaches back 6 generations to 1984. 2 later devices descend from it.
- Decided
- May 27, 2005
- Review
- 105 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K841189 (1984). 12 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 4 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 3 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 2 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 1 generation backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- This deviceK050348 CO Vertebral Body ReplacementScient'X · 2005
- Descendant · cites it directly · 0 of its ownK061752 Spinal Usa VBR SystemSpinal USA · 2006
- Descendant · cites it directly · 0 of its ownK053292 Davantis/Antelys Vertebral Body ReplacementsScient'X USA, Inc. · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −5 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −4 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −3 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −2 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −1 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| 0 (this device) | K050348 | CO Vertebral Body Replacement | Scient'X | 2005 | — |
| +1 | K061752 | Spinal Usa VBR System | Spinal USA | 2006 | — |
| +1 | K053292 | Davantis/Antelys Vertebral Body Replacements | Scient'X USA, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K033109 | Ellys and Aurys Vertebral Body ReplacementsSummary page 1…ral Body Replacement Device Classification name Class II per 21 CFR section 888.3060 Product Code NMQP Equivalent Device Sceriet'x Ellys VBR (K033109) Device Description The CO Vertebral Body Replacements are rectangular shaped and are used in pairs for full corpectomly or indi… | 2004 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 companies; a new generation was cleared every 1.7 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K061752 (Spinal USA, 2006) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K033109.
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?
CO Vertebral Body Replacements are vertebral body replacements for use in the lumbar and thoracic spine (TI-L5) to replace a damaged, collapsed or unstable vertebral body due to tumor or trauma (i.e. fiacture). These are not stand-alone devices, ISOBAR 06.2 Hemispherical Screws with Offset Clamps and 05.5 Rods must be utilized to enhance the stability of the reconstruction in skeletally mature patients following full or partial corpectomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050348 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050348: CO Vertebral Body Replacement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050348
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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