# K211935: ORIO-Ti Intervertebral Body Fusion Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Spinecraft, LLC
- Decided: Sep 30, 2021 after 100 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: 17 generations back to K003155 (2001). 347 ancestors in all.
No later device cites it as a predicate yet.
0 of 348 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090887: Orio-C Cervical, Orio-TL Tlif, Orio-PL Plif, Orio-AL Alif Intervedrtebral Body Fusion Cages, SpineCraft (2009) Summary page 4.
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 4.
- K170569: SeaSpine Shoreline ACS - Anterior Cervical Standalone System, SeaSpine Orthopedics Corporation (2017) Summary page 4.
- K173080: IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF), Huvexel Co., Ltd. (2017) Summary page 4.
- K123045: Brigade Standalone System, Nuvasive, Inc. (2013) Summary page 4.
- K143683: APEX-DL Spine System, Spinecraft, LLC (2015) Summary page 4.
- K150417: Astra Spine System, Spinecraft, LLC (2015) Summary page 4.

## Indications for use
The ORIO-Ti cervical intervertebral body fusion cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. ORIO-Ti cervical intervertebral body fusion implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. ORIO-Ti cervical intervertebral body fusion implant is to be used with supplemental fixation that has been cleared for use in the cervical spine. The ORIO-Ti 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 patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had at least six (6) months of non-operative treatment. ORIO-Ti lumbar intervertebral body fusion implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via a transforaminal, open posterior, anterior/anterolateral, or lateral approach. The ORIO-Ti lumbar intervertebral body fusion implants are to be used with supplemental fixation that have been cleared for use in the lumbosacral spine.

Source page: https://510kreport.com/device/K211935
Methodology: https://510kreport.com/methodology