# K212070: KMTI S141 Lumbar Interbody Fusion System

- Pathway: 510(k) (Special)
- Applicant: Kyocera Medical Technologies, Inc.
- Decided: Aug 30, 2021 after 59 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). 373 ancestors in all.
No later device cites it as a predicate yet.
1 of 374 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170888: Renovis S141 Lumbar Interbody Fusion System, Renovis Surgical Technologies (2017) Summary page 5.
- K143126: Renovis S141 Lumbar Interbody Cage System, Renovis Surgical Technologies (2015) Summary page 5.
- K181655: Renovis S180 Lateral Lumbar Interbody Fusion System, Renovis Surgical Technologies (2018) Summary page 5.
- K171657: ShurFit 2C Lumbar Interbody Fusion System, Precision Spine, Inc. (2017) Summary page 5.
- K113561: TM Ardis Interbody System TM Ardis Interbody System Instrumenation, Zimmer Trabecular Metal Technology (2012) Summary page 5.
- K201605: EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage, Eit Emerging Implant Technologies GmbH (2020) Summary page 5.

## Indications for use
The KMTI S141 Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). KMTI S141 System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The KMTI S141 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K212070
Methodology: https://510kreport.com/methodology