# K120966: Depuy Pulse Lumbar Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Jul 3, 2012 after 95 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: 11 generations back to K841189 (1984). 48 ancestors in all.
25 later devices descend from it; 3 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081917: Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems, Depuy Spine, Inc. (2009)
- K103488: Concorde Bullet Cage System, Johnson and Johnson (2011) Summary page 1.
- K101923: Concorde Curve System, Depuy Spine (2010) Summary page 1.
- K110694: Concorde Bullet Spinal System, Johnson & Johnson (2011) Summary page 1.
- K103034: Genesys Spine Interbody Fusion System, Genesys Spine (2010) Summary page 1.
- P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation, Stryker Spine (1996) Summary page 1.

## Most influential descendants
- K181397: DualX (2018), 15 descendants of its own
- K203038: Toro-L Interbody Fusion System (2021), 5 descendants of its own
- K173082: Arco™-SA Lumbar Cage System (2018), 5 descendants of its own
- K213355: Toro-L Interbody Fusion System (2022), 4 descendants of its own
- K222203: DualXSLIM (R) T/PLIF (2022), 3 descendants of its own

## Indications for use
The DePuy PULSE Lumbar Cage System is indicated for use as intervertebral body fusion devices 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 (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via a PLIF or TLIF approach using autogenous bone. When used as intervertebral body fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation products.

Source page: https://510kreport.com/device/K120966
Methodology: https://510kreport.com/methodology