# K090887: Orio-C Cervical, Orio-TL Tlif, Orio-PL Plif, Orio-AL Alif Intervedrtebral Body Fusion Cages

- Pathway: 510(k) (Traditional)
- Applicant: SpineCraft
- Decided: Oct 30, 2009 after 213 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.
644 later devices descend from it; 5 cite it directly.
1 of 645 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K100516: Anyplus Peek Cages (2010), 636 descendants of its own
- K131082: Interform Interbody Cage System (2013), 595 descendants of its own
- K141665: NuVasive CoRoent System (2015), 588 descendants of its own
- K151472: NuVasive CoRoent Lumbar System (2015), 479 descendants of its own
- K150994: NuVasive CoRoent Thoracolumbar Implants (2015), 402 descendants of its own

## Indications for use
The ORIO lumbar intervertebral body fusion cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). ORIO lumbar intervertebral body fusion cage implants are to be used with autogenous bone graft and implanted via a transforaminal, open posterior, anterior/anterolateral or lateral approach. The ORIO lumbar intervertebral body fusion cages are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. ORIO cervical intervertebral body fusion 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. ORIO cervical intervertebral body fusion cages 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. ORIO cervical intervertebral body fusion 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.

Source page: https://510kreport.com/device/K090887
Methodology: https://510kreport.com/methodology