# K103034: Genesys Spine Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Genesys Spine
- Decided: Dec 10, 2010 after 58 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: 10 generations back to K841189 (1984). 35 ancestors in all.
137 later devices descend from it; 22 cite it directly.
0 of 173 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- P970015: Inter Fix Threaded Fusion Device, Sofamor Danek (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.
- K043479: MC+ Partial VBR, Ldr Spine USA (2005) Summary page 1.
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 1.
- K090064: Eminent Spine Interbody Fusion System, Eminent Spine (2009) Summary page 1.

## Most influential descendants
- K120966: Depuy Pulse Lumbar Cage System (2012), 25 descendants of its own
- K120024: Mectalif Transforaminal (2012), 23 descendants of its own
- K131671: Mectalif (2013), 22 descendants of its own
- K111820: Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif Cage (2012), 20 descendants of its own
- K180056: Genesys Spine AIS-C Cervical Anchored Interbody System (2018), 18 descendants of its own

## Recalls of this device
- Aug 24, 2011 · Not classified · Z-1698-2012: The inserters have the potential to break.

## Indications for use
When used as a cervical intervertebral body fusion device, the Genesys Spine Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DOD) of the cervical spine with accompanying radicular symptoms at one disc level from the 02-03 disc to the 07-TI disc. DD 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. When used as a lumbar intervertebral body fusion device, the Genesys Spine Interbody Fusion System 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 (ODD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DOD 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. When used as a vertebral body replacement device, the Genesys Spine System 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 device system is intended for use in the thoracolumbar spine (from Ti to L5) and is intended for use with supplemental fixation. These devices are designed to restore the biomnechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The device system is intended to be used with autograft or allograft bone.

Source page: https://510kreport.com/device/K103034
Methodology: https://510kreport.com/methodology