510(k) · Cleared
Recalled · Class II · 2017Giza (R) Vertebral Body Replacement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eden Spine, LLC · MQP Spinal Vertebral Body Replacement Device
Cleared on Jan 26, 2012 as substantially equivalent to K012254 (Osteotech, Inc., 2001) and 1 other predicate after a 156-day review. Its family tree reaches back 6 generations to 2001. 2 later devices descend from it. It has been recalled once.
- Decided
- Jan 26, 2012
- Review
- 156 days
- Class
- Class II
- Product code
- MQP
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K003275 (2001). 8 ancestors in all, the oldest K003155 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK003275 Synthes Synmesh Spacer SystemSynthes (Usa) · 2001 · Recalled
- 5 generations backK020152 Synthes Vertebral Spacer TISynthes (Usa) · 2002
- 4 generations backK024364 Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa) · 2003
- 3 generations backK031302 Sustain SpacerGlobus Medical, Inc. · 2003
- 2 generations backK050850 Xpand Corpectomy SpacerGlobus Medical, Inc. · 2005
- 1 generation backK060416 Obelisc Vertebral Body Replacement DeviceUlrich GmbH & Co. KG · 2006
- This deviceK112429 Giza (R) Vertebral Body ReplacementEden Spine, LLC · 2012
- Descendant · cites it directly · 1 of its ownK192214 CarboClear VBR SystemCarboFix Orthopedics, Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK222874 CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd. · 2023
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 | K003275 | Synthes Synmesh Spacer System | Synthes (Usa) | 2001 | 14 |
| −5 | K020152 | Synthes Vertebral Spacer TI | Synthes (Usa) | 2002 | — |
| −4 | K024364 | Synthes Vertebral Spacer TI (Curved and Narrow) | Synthes (Usa) | 2003 | — |
| −3 | K031302 | Sustain Spacer | Globus Medical, Inc. | 2003 | — |
| −2 | K050850 | Xpand Corpectomy Spacer | Globus Medical, Inc. | 2005 | — |
| −1 | K060416 | Obelisc Vertebral Body Replacement Device | Ulrich GmbH & Co. KG | 2006 | — |
| 0 (this device) | K112429 | Giza (R) Vertebral Body Replacement | Eden Spine, LLC | 2012 | — |
| +1 | K192214 | CarboClear VBR System | CarboFix Orthopedics, Ltd. | 2019 | — |
| +2 | K222874 | CarboClear Cervical Cage System, CarboClear Cervical VBR System | Carbofix Orthpedics, Ltd. | 2023 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K012254 | VBRSummary page 1…ium alloy (TiEAI4V-ELI). Predicate Devices The Giza® was shown to be substantially equivalent to legally marketed predicate devices. These include the VBR by Osteotech (K012254) and the Obelisc VBR by Ulrich GmbH (K060416). Indications for Use The Giza® Vertebral Body Replacement is intended for use dur… | 2001 |
| * | K060416 | Obelisc Vertebral Body Replacement DeviceSummary page 1…he Giza® was shown to be substantially equivalent to legally marketed predicate devices. These include the VBR by Osteotech (K012254) and the Obelisc VBR by Ulrich GmbH (K060416). Indications for Use The Giza® Vertebral Body Replacement is intended for use during open surgical procedures in the thoracolu… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192214 | CarboClear VBR System | 2019 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 17, 2017 | Class II | Z-2072-2017 | Labeling design | Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K192214 (CarboFix Orthopedics, Ltd., 2019) has gone furthest, with 1 descendant of its own.
- 17 other devices also cite its predicate K012254.
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. 2012, 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 Giza® Vertebral Body Replacement is intended for use during open surgical procedures in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g. fracture). The Giza® Vertebral Body Replacement is intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the thoracic and lumbar spine (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The use of allograft or autograft with the Giza® Vertebral Body Replacement device is optional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112429 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112429: Giza (R) Vertebral Body Replacement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112429
Report an extraction error
Are you the manufacturer?
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