# K152156: Opticage Expandable Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Interventional Spine, Inc.
- Decided: Oct 19, 2015 after 77 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K160464: Opticage (R) Expandable Interbody Fusion Device (2016), 9 descendants of its own
- K171425: Concorde Lift (2017), 8 descendants of its own
- K190708: AccelFix Lumbar Interbody Fusion Cage System (2019), 5 descendants of its own
- K203531: XYPAN Expandable Lumbar Cage System (2021), 3 descendants of its own
- K221719: ABTross ALIF Expandable Cage System (2022), 2 descendants of its own

## Recalls of this device
- Apr 8, 2019 · Class II · Z-1226-2019: A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
- Nov 22, 2016 · Class II · Z-0941-2017: During implantation, the proximal end of the device could separate if the angle between the device and insertion instrument is too steep. This separation will prevent the device from expanding.

## 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-S1. 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, transforaminal or lateral 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/K152156
Methodology: https://510kreport.com/methodology