# K203038: Toro-L Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Integrity Implants, Inc.
- Decided: Mar 26, 2021 after 171 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: 21 generations back to K841189 (1984). 388 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 394 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181397: DualX, Innovasive, Inc. (2018) Summary page 6.
- K173025: NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP Expandable XLIF System, Nu Vasive, Incorporated (2018) Summary page 6.
- K113447: Rise Spacer, Globus Medical, Inc. (2012) Summary page 6.
- K123978: Capstone L Spinal System, Medtronic Sofamor Danek USA (2013) Summary page 6.
- K183184: FlareHawk Interbody Fusion System, Integrity Implants, Inc. (2019) Summary page 6.

## Most influential descendants
- K213355: Toro-L Interbody Fusion System (2022), 4 descendants of its own
- K221894: Lumbar Expandable lnterbody Spacers -Additional Indications/Implants (2023), 2 descendants of its own
- K253401: SCRIPT™ Implant System (2026), 0 descendants of its own
- K232996: Iatrical Interbody Lumbar Fusion Systems  (Model ALIF, Model TLIF, Model LLIF) (2024), 0 descendants of its own
- K234035: COSINE™ Spacer (2024), 0 descendants of its own

## Indications for use
The Toro-L Interbody Fusion System is 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 Toro-L Interbody Fusion System is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (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 Toro-L Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

Source page: https://510kreport.com/device/K203038
Methodology: https://510kreport.com/methodology