# K160959: Xsert Lumbar Expandable Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: X-Spine Systems, Inc.
- Decided: Nov 17, 2016 after 226 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). 140 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 153 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102293: Caliber Spacer, Globus Medical, Inc. (2011) Summary page 5.
- K131350: Calix Lumbar Spinal Implant System, X-Spine Systems, Inc. (2013) Summary page 5.
- K152651: AccuLIF TL and PL Cage, Stryker Corporation (2015) Summary page 5.
- K113527: Opticage Interbody Fusion Device, Interventional Spine, Inc. (2012) Summary page 5.

## Most influential descendants
- K211873: PSX Interbody System (2021), 11 descendants of its own
- K222455: Calibrate LTX Interbody System (2022), 8 descendants of its own
- K231438: Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System (2023), 7 descendants of its own
- K223611: Calibrate LTX Interbody System (2023), 7 descendants of its own
- K242364: IdentiTi™ II Interbody System (2024), 4 descendants of its own

## Indications for use
The Xsert™ Lumbar Expandable Interbody System is intended for spinal fusion procedures at one or two contiguous levels (L2 – S1 inclusive) in skeletally mature patients with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the lumbosacral spine. DDD patients may also have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved level(s). These implants are to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via a posterior, and/or transforaminal approach. Patients should receive at least six (6) months of non-operative treatment prior to treatment with a lumbosacral intervertebral fusion device. This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

Source page: https://510kreport.com/device/K160959
Methodology: https://510kreport.com/methodology