# K160906: Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Spineology, Inc.
- Decided: Jul 14, 2016 after 104 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: 18 generations back to K841189 (1984). 153 ancestors in all.
27 later devices descend from it; 4 cite it directly.
0 of 181 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150788: Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C (HA) Cervical Intervertebral Body Fusion Devices, Meditech Spine, LLC (2015) Summary page 4.
- K132053: Rampart-O, Rampart-T, Spineology, Inc. (2013) Summary page 4.
- K153082: Rampart A Lumbar Interbody Fusion Device, Spineology, Inc. (2016) Summary page 4.

## Most influential descendants
- K170643: Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System (2017), 11 descendants of its own
- K172343: Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology (2017), 10 descendants of its own
- K162879: Elite Expandable Interbody Fusion Device (2017), 9 descendants of its own
- K171425: Concorde Lift (2017), 8 descendants of its own
- K190498: Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System (2019), 7 descendants of its own

## Indications for use
Rampart™ O, Rampart™ T, and Rampart™ A implants are intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Rampart™ O, Rampart™ T, and Rampart™ A implants are designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and are intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K160906
Methodology: https://510kreport.com/methodology