# K172828: Double Medical Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Double Medical Technology, Inc.
- Decided: Feb 1, 2018 after 136 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: 11 generations back to K841189 (1984). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133053: Milestone Spinal System, Weigao Orthopaedic Device Co., Ltd. (2014) Summary page 4.
- K100089: Synthes T-Pal Spacer, Synthes Spine (2010) Summary page 4.

## Most influential descendants
- K253151: Fule Interbody Fusion Cage System (2026), 0 descendants of its own

## Indications for use
Double Medical Cage System is indicated for use in patients with degenerative disc disease (DDD) at one or two levels from L2 to L5 whose condition requires the use of interbody fusion combined with supplemental fixation. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Cage should be packed with autogenous bone graft (i.e. autograft).

Source page: https://510kreport.com/device/K172828
Methodology: https://510kreport.com/methodology