# K183049: Reliance Lumbar IBF System

- Pathway: 510(k) (Special)
- Applicant: Reliance Medical Systems, LLC
- Decided: Feb 15, 2019 after 105 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: 14 generations back to K841189 (1984). 35 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180687: Reliance Lumber IBF System, Reliance Medical Systems (2018) Summary page 4.
- 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.
- K173283: Reliance Lumbar IBF System, Reliance Medical Systems, LLC (2018) Summary page 4.

## Most influential descendants
- K212930: LumiVy Lumbar IBF System (2022), 6 descendants of its own
- K223412: LumiVy™ Lumbar IBF System (2023), 5 descendants of its own
- K230414: ClariVy™ Cervical IBF System (2023), 3 descendants of its own
- K231836: ClariVy™ Cervical IBF System (2023), 2 descendants of its own
- K233807: LumiVy™ Lumbar IBF System (2024), 1 descendant of its own

## Indications for use
The Reliance Lumbar 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. The Reliance Lumbar 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/K183049
Methodology: https://510kreport.com/methodology