# K090064: Eminent Spine Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Eminent Spine
- Decided: Apr 9, 2009 after 90 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K841189 (1984). 31 ancestors in all.
701 later devices descend from it; 34 cite it directly.
0 of 733 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P970015: Inter Fix Threaded Fusion Device, Sofamor Danek (1999) Summary page 1.
- P950002: Bak Interbody Fusion System, Zimmer Spine, Inc. (1996) Summary page 1.
- P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation, Stryker Spine (1996) Summary page 1.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 1.
- P000028: Affinity (TM) Cage System, Medtronic Sofamor Danek USA, Inc. (2002) Summary page 1.
- K081614: Zeus Small Cervical Cage and Large, Extra Large, Curved and Straight Lumbar Cages, Interbody Innovations, Llp (2008) Summary page 1.
- K043479: MC+ Partial VBR, Ldr Spine USA (2005) Summary page 1.
- K073351: Crystal, Spinal Elements, Inc. (2008) Summary page 1.

## Most influential descendants
- 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
- K123206: Maxim Surgical X-Treme Interbody Fusion System (2013), 454 descendants of its own
- K140003: Coroent Small Interbody System (2014), 453 descendants of its own

## Recalls of this device
- Feb 20, 2013 · Class II · Z-1417-2013: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to ev

## Indications for use
Intervertebral Body Fusion Device: The Eminent Spine Interbody Fusion System (Sidewinder, Python, and Cottonmouth) is indicated for intervertebral body fusion of the lumbar spine, from L2 to Si, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. The Eminent Spine Interbody Fusion System (Copperhead) is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. Vertebral Body Replacement Device: The Eminent Spine System of implants is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The Eminent Spine System is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with autograft or allograft bone.

Source page: https://510kreport.com/device/K090064
Methodology: https://510kreport.com/methodology