# K131122: S128 Anterior Lumbar Interbody Fusion (Alif) System

- Pathway: 510(k) (Abbreviated)
- Applicant: Renovis Surgical Technologies, LLC
- Decided: Sep 18, 2013 after 149 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: 13 generations back to K841189 (1984). 67 ancestors in all.
269 later devices descend from it; 6 cite it directly.
0 of 337 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081177: Blackstone Medical, Inc., Pillar Spacer System, Blackstone Medical, Inc. (2008)
- K092211: Chesapeake Spinal System, K2m, Inc. (2010) Summary page 1.
- K123767: Lanx Fusion System- SA, Lanx, Inc. (2013) Summary page 1.
- K102738: Lanx Fusion System, Lanx, LLC (2011) Summary page 1.
- K083815: Lanx Fusion System, Lanx, Inc. (2009) Summary page 1.
- K073144: Lanx Intervertebral Body Fusion Device, Lanx, LLC (2008) Summary page 1.
- K082260: Integra Cervical and Petra Plif Lumbar Cages, Calvary Spine, LLC (2008) Summary page 1.

## Most influential descendants
- K140106: S128 Anterior Lumbar Interbody Fusion (Alif) System (2014), 265 descendants of its own
- K142095: Renovis S134 Anterior Lumbar Interbody Fusion (Alif) System (2014), 254 descendants of its own
- K143126: Renovis S141 Lumbar Interbody Cage System (2015), 237 descendants of its own
- K151374: NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System (2015), 235 descendants of its own
- K153105: MLX™ - Medial Lateral Expandable Lumbar Interbody System (2016), 234 descendants of its own

## Indications for use
The Renovis S 128 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 I 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 S 128 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.

Source page: https://510kreport.com/device/K131122
Methodology: https://510kreport.com/methodology