# K122168: Visualif Challenging Access Plate

- Pathway: 510(k) (Special)
- Applicant: Spine Smith Partners L.P.
- Decided: Oct 11, 2012 after 80 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 3 generations back to P950002 (1996). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102090: Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant System, Spine Smith Partners L.P. (2010) Summary page 1.

## Most influential descendants
- K161993: Leva® Anterior Interbody System (2016), 0 descendants of its own

## Indications for use
The VisuALIF System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, 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 autograft to facilitate fusion. The VisuALIF is a stand-alone device intended to be used with an anterior cover plate and a minimum of two provided bone screws angled both cephalad and caudal with a minimum of one screw into each vertebral body. Should the physician choose to use fewer than the two screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided.

Source page: https://510kreport.com/device/K122168
Methodology: https://510kreport.com/methodology