# K221844: TDM Lumbar Interbody Fusion Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Tdm Co., Ltd.
- Decided: Aug 17, 2022 after 54 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 K003155 (2001). 70 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100516: Anyplus Peek Cages, GS Medical Co., Ltd. (2010) Summary page 5.
- K122872: Intervertebral Body Fusion Device, Dio Medical Co., Ltd. (2013) Summary page 5.

## Most influential descendants
- K213653: 4CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage System (2022), 0 descendants of its own

## Indications for use
TDM Lumbar Interbody Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, who have had six months of non-operative treatment. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. TDM Lumbar Interbody Fusion Cage System is to be used with supplemental fixation.

Source page: https://510kreport.com/device/K221844
Methodology: https://510kreport.com/methodology