# K163506: Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Vertera, Inc.
- Decided: Jun 19, 2017 after 187 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: 13 generations back to K003155 (2001). 64 ancestors in all.
224 later devices descend from it; 2 cite it directly.
0 of 289 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140348: Interbody Cage, Eisertech, LLC (2015) Summary page 4.

## Most influential descendants
- K173153: Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System (2017), 160 descendants of its own
- K181860: NuVasive Cohere Thoracolumbar Interbody System (2018), 159 descendants of its own
- K193541: NuVasive Cohere Thoracolumbar Interbody System (2020), 157 descendants of its own
- K201820: NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System (2020), 156 descendants of its own
- K200953: NuVasive® Cohere® Thoracolumbar Interbody System (2020), 141 descendants of its own

## Indications for use
The Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine with accompanying radicular symptoms. Implants are used to facilitate fusion in the lumbar spine (L2 to S1), and are intended to be used with autogenous bone graft and supplemental fixation systems that have been cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K163506
Methodology: https://510kreport.com/methodology