# K171425: Concorde Lift

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Jul 20, 2017 after 66 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
Longest line of descent: 20 generations back to K841189 (1984). 159 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 168 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160464: Opticage (R) Expandable Interbody Fusion Device, Interventional Spine, Inc. (2016) Summary page 4.
- K152156: Opticage Expandable Interbody Fusion Device, Interventional Spine, Inc. (2015) Summary page 4.
- K113527: Opticage Interbody Fusion Device, Interventional Spine, Inc. (2012) Summary page 4.
- K162879: Elite Expandable Interbody Fusion Device, Spineology, Inc. (2017) Summary page 4.

## Most influential descendants
- 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
- K223474: PathLoc-TA Expandable Lumbar Cage System (2023), 1 descendant of its own

## Recalls of this device
- Apr 8, 2019 · Class II · Z-1225-2019: A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
- Jul 26, 2017 · Class II · Z-0848-2018: Potential for Intra-operative breakage of driver tips

## Indications for use
The CONCORDE LIFT Expandable Interbody Device is a lumbar intervertebral body fusion device, and is indicated for use with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine, L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The CONCORDE LIFT Expandable Interbody 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 a six-month course 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.

Source page: https://510kreport.com/device/K171425
Methodology: https://510kreport.com/methodology