510(k) · Cleared
ClearedSAGI Cervical Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ZheJiang Decans Medical Devices Co., Ltd. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Apr 20, 2026 as substantially equivalent to K102606 (Stryker Spine, 2011) and 4 other predicates after a 203-day review. Its family tree reaches back 17 generations to 2001.
- Decided
- Apr 20, 2026
- Review
- 203 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 17 generations to K003155 (2001). 134 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.
- Root · 17 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations between
- 3 generations backK132584 Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 2 generations backK153373 CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System…Medtronic Sofamor Danek · 2016
- 1 generation backK242195 Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd. · 2024
- This deviceK253213 SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd. · 2026
Show all 17 generations
- Root · 17 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 16 generations backK012254 VBROsteotech, Inc. · 2001
- 15 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 14 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 13 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 12 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 8 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 7 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 6 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 5 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 4 generations backK100967 Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 3 generations backK132584 Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 2 generations backK153373 CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System…Medtronic Sofamor Danek · 2016
- 1 generation backK242195 Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd. · 2024
- This deviceK253213 SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −16 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −15 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −14 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −13 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −12 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −11 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −10 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −8 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −7 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −6 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −5 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| −4 | K100967 | Perimeter C Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −3 | K132584 | Perimeter C Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −2 | K153373 | CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK… | Medtronic Sofamor Danek | 2016 | — |
| −1 | K242195 | Gemini Cervical Fusion Cage System | ZheJiang Decans Medical Devices Co., Ltd. | 2024 | — |
| 0 (this device) | K253213 | SAGI Cervical Cage System | ZheJiang Decans Medical Devices Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 12 | 0 |
| 2004 | 17 | 0 |
| 2005 | 7 | 0 |
| 2006 | 3 | 0 |
| 2007 | 10 | 0 |
| 2008 | 16 | 0 |
| 2009 | 8 | 0 |
| 2010 | 7 | 0 |
| 2011 | 6 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2024 | 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 OVE? 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 OVE device
- #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K102606 | Avs Anchor-C Cervical Cage SystemSummary page 5…tryker Spine AVS® Anchor-C Cervical Cage Trade name System Primary Predicate 510(K) number K102606 Device Regulatory Class II Regulation Number 21 CFR 888.3080… | 2011 |
| * | K072981 | Synthes Zero-PSummary page 5…OVE Manufacturer DePuy Synthes Trade name Synthes Zero-P 510(K) number K072981 Additional Predicate Regulatory Class II Device Regulation Number 21 CFR 8… | 2008 |
| * | K112068 | Synthes Zero-P Variable Angle (VA)Summary page 5…ufacturer Synthes Spine Co., L.P. Trade name Synthes Zero-P Variable Angle (VA) 510(K) number K112068 Additional Predicate Regulatory Class II Device Regulation Number 21 CFR 8… | 2011 |
| * | K242195 | Gemini Cervical Fusion Cage SystemSummary page 6…1 of 3 K253213 510(K) number K242195 Regulatory Class II Regulation Number 21 CFR 888.3080… | 2024 |
| * | K242267 | Gemini Medical Cage SystemSummary page 6…ZheJiang Decans Medical Devices Co., Ltd. Trade name Gemini Medical Cage System 510(K) number K242267 Additional Predicate Regulatory Class II Device Regulation Number 21 C… | 2024 |
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 25 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 16 of the 134 ancestors have a recall of any class.
- 16 other devices also cite its predicate K102606.
How does its category compare?
All OVE devicesOVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OVE
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVE
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVE
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVE
132in 2025
MAUDE reports naming product code OVE, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 131 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 210 | 0 | 2 |
| 2011 | 8 | 139 | 0 | 19 |
| 2012 | 7 | 125 | 0 | 59 |
| 2013 | 5 | 71 | 1 | 250 |
| 2014 | 11 | 168 | 1 | 150 |
| 2015 | 12 | 113 | 1 | 173 |
| 2016 | 15 | 149 | 1 | 145 |
| 2017 | 9 | 100 | 1 | 134 |
| 2018 | 7 | 105 | 0 | 210 |
| 2019 | 7 | 87 | 0 | 169 |
| 2020 | 13 | 149 | 0 | 162 |
| 2021 | 10 | 93 | 2 | 186 |
| 2022 | 10 | 144 | 0 | 200 |
| 2023 | 16 | 97 | 0 | 148 |
| 2024 | 6 | 56 | 0 | 142 |
| 2025 | 10 | 105 | 0 | 132 |
| 2026 | 13 | 66 | 0 | — |
What is it indicated for?
The SAGI Cervical Cage System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The SAGI Cervical Cage System is designed for use with autogenous bone graft to facilitate fusion and is to be implanted via an open, anterior approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253213 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253213: SAGI Cervical Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253213
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026