# K181118: Reliance Lumbar IBF System

- Pathway: 510(k) (Traditional)
- Applicant: Reliance Medical Systems
- Decided: Jan 9, 2019 after 257 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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). 121 ancestors in all.
No later device cites it as a predicate yet.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113540: Reliance Lumbar Ibf System, Reliance Medical Systems, LLC (2012) Summary page 4.
- K160463: Reliance Lumbar IBF System, Reliance Medical Systems, LLC (2016) Summary page 4.
- K103382: Intercontinental Plate-Spacer, Globus Medical, Inc. (2011) Summary page 4.
- K120101: Independence Spacer, Globus Medical, Inc. (2012) Summary page 4.
- K120031: Chesapeake Spinal System, K2m, Inc. (2012) Summary page 4.
- K131547: Lanx Fusion System, Lanx, Inc. (2013) Summary page 4.
- K131276: Lateral Synfix, Synthes (USA) Products, LLC (2014) Summary page 4.

## Indications for use
The Reliance LXPEDU IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level. Additional supplemental fixation is not necessary for the Lumbar IBF-S if the integrated screws are implanted. The Reliance LXPEDU IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.

Source page: https://510kreport.com/device/K181118
Methodology: https://510kreport.com/methodology