# K213653: 4CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Solco Biomedical Company India Private Limited
- Decided: Dec 19, 2022 after 395 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: 19 generations back to K841189 (1984). 253 ancestors in all.
No later device cites it as a predicate yet.
1 of 254 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221844: TDM Lumbar Interbody Fusion Cage System, Tdm Co., Ltd. (2022). Cleared while this submission was under review Summary page 4.
- K190563: 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage, Solco Biomedical Co., Ltd. (2019) Summary page 4.
- K162358: T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System, Synthes USA Products, LLC (2016) Summary page 4.

## Indications for use
The Spinal Fusion Cage System is an intervertebral body fusion devices intended for use to skeletally mature patients with Degenerative Disk Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Spinal Fusion Cage System is indicated to be used with autologous bone graft to facilitate fusion and are intended to be used with supplemental fixation. The device is to be used in patients who have had six months of nonoperative treatment.

Source page: https://510kreport.com/device/K213653
Methodology: https://510kreport.com/methodology