# K170844: Gemini-C Hybrid Cervical Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Osseus Fusion Systems, LLC
- Decided: Jul 3, 2017 after 104 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: 16 generations back to K003155 (2001). 142 ancestors in all.
No later device cites it as a predicate yet.
1 of 143 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150619: CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System, Orthofix, Inc. (2015) Summary page 4.
- K073351: Crystal, Spinal Elements, Inc. (2008) Summary page 4.
- K100889: Endoskeleton TC, Titan Spine, LLC (2010) Summary page 4.
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 4.
- K083425: Fusion Advantage Cervical Cage, Fusion Advantage Lumbar Cage, Adaptive Specialty, LLC (2009) Summary page 4.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 4.
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 4.
- K140280: Forticore, Nanovis, LLC (2014) Summary page 4.
- K121741: 4-Web Cervical STS (Spinal Truss System), 4-Web, Inc. (2012) Summary page 4.

## Indications for use
The Gemini-C Hybrid Cervical Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels within the cervical spine at disc levels from C2 to T1. Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. This device is intended for use with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation (i.e. anterior cervical plate such as the White Pearl Preferred Angle Anterior Cervical Plate). Patients should have had at least six weeks of non-operative treatment prior to treatment with intervertebral cages.

Source page: https://510kreport.com/device/K170844
Methodology: https://510kreport.com/methodology