# K170888: Renovis S141 Lumbar Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Renovis Surgical Technologies
- Decided: Aug 8, 2017 after 134 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: 15 generations back to K841189 (1984). 154 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 160 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143125: Orthofix True Lok Hexapod System VI.3, Orthofix Srl (2014) Summary page 4.
- K150481: Cascadia Interbody System, K2m, Inc. (2015) Summary page 4.

## Most influential descendants
- K181655: Renovis S180 Lateral Lumbar Interbody Fusion System (2018), 4 descendants of its own
- K242771: Tesera-k PL System and Tesera-k XL System (2025), 1 descendant of its own
- K261353: Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System (2026), 0 descendants of its own
- K212070: KMTI S141 Lumbar Interbody Fusion System (2021), 0 descendants of its own
- K182007: Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System (2018), 0 descendants of its own

## Indications for use
The Renovis 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). 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/K170888
Methodology: https://510kreport.com/methodology