# K180502: S128 Anterior Lumbar Interbody Fusion (ALIF) System

- Pathway: 510(k) (Traditional)
- Applicant: Renovis Surgical Technologies, Inc.
- Decided: Jun 14, 2018 after 108 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 15 generations back to K841189 (1984). 69 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140106: S128 Anterior Lumbar Interbody Fusion (Alif) System, Renovis Surgical Technologies, Inc. (2014) Summary page 4.
- K131122: S128 Anterior Lumbar Interbody Fusion (Alif) System, Renovis Surgical Technologies, LLC (2013) Summary page 4.

## Most influential descendants
- K193320: KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System (2020), 3 descendants of its own
- K193645: nva, nvp, and nvt (2020), 3 descendants of its own
- K212980: Tesera-k ALIF System (2022), 2 descendants of its own
- K242771: Tesera-k PL System and Tesera-k XL System (2025), 1 descendant of its own
- K212477: EARP Interbody System (2022), 1 descendant of its own

## Indications for use
The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) 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). Renovis S128 ALIF 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 Renovis S128 ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the physician choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°.

Source page: https://510kreport.com/device/K180502
Methodology: https://510kreport.com/methodology