# K102322: Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant (Tlif); Great White Implants (Alif)

- Pathway: 510(k) (Traditional)
- Applicant: Omni Surgical, L.P.
- Decided: Jan 7, 2011 after 143 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- 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: 9 generations back to K841189 (1984). 27 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.
- K072120: Paramount Intervertebral Body Fusion Device, Innovative Spinal Technologies, Inc. (2007) Summary page 1.
- K073351: Crystal, Spinal Elements, Inc. (2008) Summary page 2.
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 2.

## Most influential descendants
- K131981: Cezanne II Interbody Fusion System (2013), 5 descendants of its own
- K192863: MONDRIAN Lumbar Interbody Fusion Cage System (2020), 3 descendants of its own
- K213641: MONDRIAN ALIF Cage with Supplementary Fixation Plate (2022), 1 descendant of its own
- K231715: MONDRIAN™ Anterior Lumbar Plate System (2024), 0 descendants of its own
- K220513: NITRO Interbody Fusion Cage System Family (2023), 0 descendants of its own

## Indications for use
The Spine 360 Lumbar Interbody Fusion System 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 DODD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Spine 360 Lumbar Interbody Fusion System implants are to be used with autogenous bone graft. The Spine 360 Lumbar Interbody Fusion System implants 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. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

Source page: https://510kreport.com/device/K102322
Methodology: https://510kreport.com/methodology