# K162879: Elite Expandable Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Spineology, Inc.
- Decided: Jan 30, 2017 after 108 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: 19 generations back to K841189 (1984). 156 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 166 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133459: Elite Ibf, Innova Spinal Technologies, LLC (2014) Summary page 4.
- K160906: Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device, Spineology, Inc. (2016) Summary page 4.
- K102293: Caliber Spacer, Globus Medical, Inc. (2011) Summary page 4.
- K113527: Opticage Interbody Fusion Device, Interventional Spine, Inc. (2012) Summary page 4.

## Most influential descendants
- 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
- K231680: AccelFix Lumbar Expandable Cage System (2023), 1 descendant of its own

## Indications for use
Elite™ Expandable implants are intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Elite™ Expandable implants are designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and are intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K162879
Methodology: https://510kreport.com/methodology