# K241073: DZ-Tabone Intervertebral Body Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Dazhou Medical Technology Co., Ltd.
- Decided: Dec 6, 2024 after 231 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: 10 generations back to K841189 (1984). 25 ancestors in all.
No later device cites it as a predicate yet.
1 of 26 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123602: TM Ardis Interbody System Inserter, Zimmer Trabecular Metal Technology (2013) Summary page 5.
- K111119: Trabecular Metal (TM) Fusion Device, Zimmer Spine, Inc. (2011) Summary page 6.

## Indications for use
DZ-Tabone Intervertebral Body Fusion Device can be divided into two types, CIF-PTA and LIF-PTA. The CIF-PTA is a cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with/ without 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 CIF-PTA is intended for use with supplemental fixation systems and with autogenous bone graft. The CIF-PTA is implanted via an anterior approach. The LIF-PTA is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment. The LIF-PTA is implanted using a posterior approach and is intended to be used in pairs with supplemental fixation. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.

Source page: https://510kreport.com/device/K241073
Methodology: https://510kreport.com/methodology