510(k) · Cleared
ClearedVerteFIT Corpectomy Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ldr Spine USA, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on May 16, 2017 as substantially equivalent to K111294 (K2m, Inc., 2012) and 1 other predicate after a 288-day review. Its family tree reaches back 11 generations to 2001.
- Decided
- May 16, 2017
- Review
- 288 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K003155 (2001). 43 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 backK060506 Stryker Spine Vlift Vertebral Body Replacement SystemStryker Spine · 2006
- 2 generations backK112756 Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc. · 2011
- 1 generation backK121107 Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc. · 2012
- This deviceK162133 VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc. · 2017
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 backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 6 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 5 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 4 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 3 generations backK060506 Stryker Spine Vlift Vertebral Body Replacement SystemStryker Spine · 2006
- 2 generations backK112756 Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc. · 2011
- 1 generation backK121107 Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc. · 2012
- This deviceK162133 VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc. · 2017
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 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −6 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −5 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −4 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −3 | K060506 | Stryker Spine Vlift Vertebral Body Replacement System | Stryker Spine | 2006 | — |
| −2 | K112756 | Fortify (TM) and Fortify (TM)-R Corpectomy Spacers | Globus Medical, Inc. | 2011 | — |
| −1 | K121107 | Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R) | Globus Medical, Inc. | 2012 | — |
| 0 (this device) | K162133 | VerteFIT Corpectomy Cage System | Ldr Spine USA, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 6 | 0 |
| 2004 | 8 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K111294 | Santorini Spinal SystemSummary page 4…MQP Classification: Class II (21 CFR 888.3060) Predicate Devices: Primary Predicate: K2M Santorini Corpectomy Cage System (K111294, January 27, 2012) Secondary Predicate: Globus Medical FORTIFYTM I-R (K121107… | 2012 |
| * | K121107 | Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Summary page 4…K2M Santorini Corpectomy Cage System (K111294, January 27, 2012) Secondary Predicate: Globus Medical FORTIFYTM I-R (K121107, July 3, 2012) Reference Predicate: LDR Spine ROI-C Titanium (K151934, Decemb… | 2012 |
| † | K151934 | ROI-C Titanium-Coated Implant System | 2015 |
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 16 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 5 of the 43 ancestors have a recall of any class.
- 4 other devices also cite its predicate K111294.
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. 2017, 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 VerteFIT™ Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 to LS5) to replace collapsed, damaged or unstable vertebral bodies due to tumor or trauma (i.e., fracture). The VerteFIT Corpectomy Cage System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The VerteFIT Corpectomy Cage System device may be used with allograft or…
Read the full statement (115 words)
The VerteFIT™ Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 to LS5) to replace collapsed, damaged or unstable vertebral bodies due to tumor or trauma (i.e., fracture). The VerteFIT Corpectomy Cage System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The VerteFIT Corpectomy Cage System device may be used with allograft or autograft. The VerteFIT implants are intended to be used with supplemental spinal fixation systems that have been cleared by FDA for use in the thoracic and/or lumbar spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162133: VerteFIT Corpectomy Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162133
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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