# K143126: Renovis S141 Lumbar Interbody Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Renovis Surgical Technologies
- Decided: Feb 6, 2015 after 98 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: 16 generations back to K841189 (1984). 97 ancestors in all.
237 later devices descend from it; 2 cite it directly.
0 of 335 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142095: Renovis S134 Anterior Lumbar Interbody Fusion (Alif) System, Renovis Surgical Technologies, Inc. (2014) Summary page 4.
- P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation, Stryker Spine (1996) Summary page 4.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 4.
- K133614: Aleutian Ibf System, K2m, Inc. (2014) Summary page 4.

## Most influential descendants
- 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
- K172123: NuVasive® Modulus XLIF Interbody System (2017), 227 descendants of its own
- K192760: NuVasive Modulus XLIF Interbody System (2019), 163 descendants of its own
- K193593: NuVasive 3DP Interfixated ALIF System (2020), 157 descendants of its own

## Indications for use
The Renovis S141 Lumbar Interbody Cage 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 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 Renovis S141 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K143126
Methodology: https://510kreport.com/methodology