# K113527: Opticage Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Interventional Spine, Inc.
- Decided: Jan 20, 2012 after 51 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: 11 generations back to K841189 (1984). 21 ancestors in all.
103 later devices descend from it; 8 cite it directly.
0 of 125 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080537: L-Varlock, Kiscomedica S.A. (2008) Summary page 1.
- K102293: Caliber Spacer, Globus Medical, Inc. (2011) Summary page 1.

## Most influential descendants
- K153400: ProLift Expandable System (2016), 72 descendants of its own
- K173182: ProLift® Expandable System (2017), 37 descendants of its own
- K162918: Atlas Spine Expandable Interbody System (2017), 29 descendants of its own
- K172696: FORZA® XP Expandable Spacer System (2018), 25 descendants of its own
- K123461: Staxx (R) IB System (2013), 25 descendants of its own

## Indications for use
The Opticage Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S 1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior or transforaminal approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels. The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

Source page: https://510kreport.com/device/K113527
Methodology: https://510kreport.com/methodology