# K120396: Reliance Cervical Ibf System

- Pathway: 510(k) (Traditional)
- Applicant: Reliance Medical Systems, LLC
- Decided: May 8, 2012 after 90 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: 10 generations back to K841189 (1984). 34 ancestors in all.
25 later devices descend from it; 5 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081730: Novel Cervical Spinal Spacer System, Alphatec Spine, Inc. (2008) Summary page 1.
- K073177: Pioneer Intervertebral Fusion Device System, Pioneer Surgical Technology (2008) Summary page 1.
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 1.

## Most influential descendants
- K131429: Reliance Cervical Ibf System (2013), 24 descendants of its own
- K142269: Reliance Cervical IBF System (2015), 23 descendants of its own
- 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

## Indications for use
The RELIANCE CERVICAL IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patienits. 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 CERVICAL IBF System is intended for use at one level in the cervical spine, from C3 to TI, for treatment of cervical degenerate disc disease (DDD is defined as 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/K120396
Methodology: https://510kreport.com/methodology