# K121693: A-Wedge Anterior Interbody System (a-Wedge Ais)

- Pathway: 510(k) (Traditional)
- Applicant: Sapphire Medical Group, Inc.
- Decided: Dec 27, 2012 after 203 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: 14 generations back to K841189 (1984). 69 ancestors in all.
21 later devices descend from it; 3 cite it directly.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111166: A-Wedge Anterior Interbody System (a-Wedge a.I.S.), Spineworks, LLC (2011)

## Most influential descendants
- K132738: Cogent Med-Lif (2014), 13 descendants of its own
- K133340: Spineworks Anterior Lumbar Device (2014), 13 descendants of its own
- K153123: Genesys Spine Apache Interbody Fusion System (2016), 12 descendants of its own
- K142193: Cogent Med-Lif XL (2014), 12 descendants of its own
- K161438: Genesys Spine Apache® Anterior Lumbar Interbody Fusion System (2016), 11 descendants of its own

## Indications for use
The A-Wedge Anterior Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DODD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). A-Wedge Anterior Interbody System implants are to be used with autogenous bone graft and implanted via an anterior, lateral or anterolateral approach. A-Wedge Anterior Interbody System implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

Source page: https://510kreport.com/device/K121693
Methodology: https://510kreport.com/methodology