# K242267: Gemini Medical Cage System

- Pathway: 510(k) (Traditional)
- Applicant: ZheJiang Decans Medical Devices Co., Ltd.
- Decided: Oct 8, 2024 after 68 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- 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: 13 generations back to K841189 (1984). 72 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 5.
- K101923: Concorde Curve System, Depuy Spine (2010) Summary page 5.
- K100089: Synthes T-Pal Spacer, Synthes Spine (2010) Summary page 5.
- K072791: Oracle Spacer, Opal Spacer, Synthes Spine (2007) Summary page 5.
- K132897: Clydesdale Spinal System, Medtronic Sofamor Danek, Inc. (2013) Summary page 5.

## Most influential descendants
- K253213: SAGI Cervical Cage System (2026), 0 descendants of its own

## Indications for use
The Gemini Medical Cage System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended to be used with supplemental fixation.

Source page: https://510kreport.com/device/K242267
Methodology: https://510kreport.com/methodology