# K192115: SABLE Expandable Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jan 14, 2020 after 161 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: 21 generations back to K841189 (1984). 343 ancestors in all.
37 later devices descend from it; 9 cite it directly.
1 of 381 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113447: Rise Spacer, Globus Medical, Inc. (2012) Summary page 4.
- K140411: Altera Spacer, Globus Medical, Inc. (2014) Summary page 4.
- K181357: PATRIOT® Lumbar Spacers, SUSTAIN® Spacers, Globus Medical, Inc. (2018) Summary page 4.
- K170318: NeoFuse Ti3D PLIF/TLIF/Cervical Interbody, Ht Medical, LLC (2017) Summary page 4.

## Most influential descendants
- K222270: HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments (2022), 23 descendants of its own
- K241846: E3D™-C Interbody System (2024), 6 descendants of its own
- K243635: aprevo® anterior lumbar interbody fusion device with interfixation (2024), 5 descendants of its own
- K231199: Solar Lumbar Interbody Fusion System (2023), 5 descendants of its own
- K240326: Solar™ Lumbar Interbody Fusion System (2024), 4 descendants of its own

## Indications for use
SABLE™ Expandable Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone and is to be used with supplemental fixation.

Source page: https://510kreport.com/device/K192115
Methodology: https://510kreport.com/methodology