# K081614: Zeus Small Cervical Cage and Large, Extra Large, Curved and Straight Lumbar Cages

- Pathway: 510(k) (Traditional)
- Applicant: Interbody Innovations, Llp
- Decided: Sep 5, 2008 after 88 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
No predicates in its family tree.
843 later devices descend from it; 9 cite it directly.
0 of 844 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) previously cleared cervical intervertebral body fusion devices: named in the summary without a submission number
- (no number) previously cleared lumbar intervertebral body fusion devices: named in the summary without a submission number

## Most influential descendants
- K090064: Eminent Spine Interbody Fusion System (2009), 701 descendants of its own
- K131372: Mobis II (2013), 462 descendants of its own
- K141405: Mobis II ST Spinal Implant (2014), 461 descendants of its own
- K150481: Cascadia Interbody System (2015), 459 descendants of its own
- K100889: Endoskeleton TC (2010), 455 descendants of its own

## Indications for use
Zeus Small Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Zeus Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Zeus Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. The Zeus Anterior Lumbar Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. Zeus implants are to be used with autogenous bone graft and implanted via an anterior approach. The Zeus Anterior Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. The Zeus Curved Lumbar Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. Zeus implants are to be used with autogenous bone graft and implanted via a transforaminal approach. The Zeus Curved Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. The Zeus Straight Lumbar Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. Zeus implants are to be used with autogenous bone graft and implanted via a posterior approach. The Zeus Straight Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K081614
Methodology: https://510kreport.com/methodology