# K142269: Reliance Cervical IBF System

- Pathway: 510(k) (Traditional)
- Applicant: Reliance Medical Systems, LLC
- Decided: Jun 9, 2015 after 298 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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). 160 ancestors in all.
23 later devices descend from it; 4 cite it directly.
0 of 184 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120396: Reliance Cervical Ibf System, Reliance Medical Systems, LLC (2012) Summary page 4.
- K131429: Reliance Cervical Ibf System, Reliance Medical Systems, LLC (2013) Summary page 4.
- K142026: Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion Device, Spinefrontier, Inc. (2014). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K172489: Reliance Cervical IBF System (2017), 16 descendants of its own
- K173102: Reliance Cervical IBF System (2017), 15 descendants of its own
- K212358: Romero Cervical Cage (2022), 6 descendants of its own
- K212715: Vy Spine ClariVy Cervical IBF System (2021), 6 descendants of its own
- K161809: ShurFit CpTi-HA ACIF Interbody Fusion System (2016), 5 descendants of its own

## Indications for use
The RELIANCE CERVICAL IBF System is indicated for intervertebral body fusion of the spme in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per mntervertebral space. The Reliance Cervical IBF and Rehiance Cervical IBF-HA implants are intended to be used with legally cleared supplemental spmal fixation cleared for the implanted level. The RELIANCE CERVICAL IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical disc disease (defined at neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The RELIANCE CERVICAL IBF System is to be used in patients who have six weeks of non-operative treatment.

Source page: https://510kreport.com/device/K142269
Methodology: https://510kreport.com/methodology