# K211845: Deploy Expandable Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Southern Spine, LLC
- Decided: Nov 16, 2021 after 154 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: 22 generations back to K841189 (1984). 250 ancestors in all.
No later device cites it as a predicate yet.
1 of 251 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151322: Amendia Interbody Fusion Devices, Amendia, Inc. (2015) Summary page 4.
- K163364: MOJAVE Expandable Interbody System, K2m (2017) Summary page 4.
- K171097: MOJAVE Expandable Interbody System, K2m, Inc. (2017) Summary page 4.
- K072791: Oracle Spacer, Opal Spacer, Synthes Spine (2007) Summary page 4.

## Indications for use
The Deploy™ Expandable Interbody System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients should be skeletally mature and have at least six months of non-operative treatment prior to being treated with this system. Additionally, the Deploy™ implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. Deploy™ implants are intended to be used with supplemental spinal fixation systems that are cleared for use in the lumbosacral spine.

Source page: https://510kreport.com/device/K211845
Methodology: https://510kreport.com/methodology