# K253213: SAGI Cervical Cage System

- Pathway: 510(k) (Traditional)
- Applicant: ZheJiang Decans Medical Devices Co., Ltd.
- Decided: Apr 20, 2026 after 203 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K003155 (2001). 134 ancestors in all.
No later device cites it as a predicate yet.
0 of 135 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102606: Avs Anchor-C Cervical Cage System, Stryker Spine (2011) Summary page 5.
- K072981: Synthes Zero-P, Synthes Spine Co.Lp (2008) Summary page 5.
- K112068: Synthes Zero-P Variable Angle (VA), Synthes Spine Co.Lp (2011) Summary page 5.
- K242195: Gemini Cervical Fusion Cage System, ZheJiang Decans Medical Devices Co., Ltd. (2024) Summary page 6.
- K242267: Gemini Medical Cage System, ZheJiang Decans Medical Devices Co., Ltd. (2024) Summary page 6.

## Indications for use
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.

Source page: https://510kreport.com/device/K253213
Methodology: https://510kreport.com/methodology