# K232996: Iatrical Interbody Lumbar Fusion Systems  (Model ALIF, Model TLIF, Model LLIF)

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Iatrical-Ti Technologies CO, Ltd.
- Decided: Sep 6, 2024 after 350 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: 23 generations back to K841189 (1984). 390 ancestors in all.
No later device cites it as a predicate yet.
0 of 391 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213355: Toro-L Interbody Fusion System, Integrity Implants, Inc. (2022) Summary page 5.

## Indications for use
The latrical Lumbar Interbody Fusion Systems are indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or cortical cancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems (e.g., pedicle screw/rod systems) cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment. The latrical Lumbar Interbody Fusion Systems are intended for use in interbody fusions at the thoracolumbar junction (T12-L1), and are intended for use in the lumbar spine, from L1 to S1, for the treatment of degenerative disc disease (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The latrical Lumbar Interbody Fusion Systems can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

Source page: https://510kreport.com/device/K232996
Methodology: https://510kreport.com/methodology