# K110659: Medical Concepts Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Concepts, Inc.
- Decided: Sep 13, 2011 after 190 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: 10 generations back to K841189 (1984). 35 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090064: Eminent Spine Interbody Fusion System, Eminent Spine (2009) 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.

## Most influential descendants
- K254130: C.A. Medical Interbody Fusion System (2026), 0 descendants of its own

## Indications for use
When used as a cervical intervertebral body fusion device, the Medical Concepts Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (ODD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-TI disc. DODD 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 Medical Concepts Interbody Fusion System is indicated for intervertelbral 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). DOID 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 Medical Concepts 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/K110659
Methodology: https://510kreport.com/methodology