# K151665: SUSTAIN Additional Implants

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Mar 16, 2016 after 271 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: 17 generations back to K841189 (1984). 129 ancestors in all.
119 later devices descend from it; 3 cite it directly.
0 of 249 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130478: Sustain and Sustain Radiolucent Spacers, Globus Medical, Inc. (2013) Summary page 4.
- K102293: Caliber Spacer, Globus Medical, Inc. (2011) Summary page 4.
- K123231: Caliber Spacers, Globus Medical, Inc. (2013) Summary page 4.
- K120368: Capstone Control Spinal System, Medtronic Sofamor Danek USA, Inc. (2012) Summary page 4.
- K100043: Coroent XLR Standalone System, Nuvasive, Inc. (2010) Summary page 4.
- K143163: AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System, Stryker Corporation (2015) Summary page 4.

## Most influential descendants
- K181357: PATRIOT® Lumbar Spacers, SUSTAIN® Spacers (2018), 97 descendants of its own
- K191391: HEDRON Lumbar Spacers (2019), 84 descendants of its own
- K171848: FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, MAGNIFY Spacers, INDEPENDENCE Spacers (2017), 55 descendants of its own
- K192115: SABLE Expandable Spacer (2020), 37 descendants of its own
- K201087: CORBEL Spacers (2020), 36 descendants of its own

## Indications for use
When used as lumbar intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R and SUSTAIN®-IR) are 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). SUSTAIN® Spacers are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These devices are intended to be used with supplemental fixation.

Source page: https://510kreport.com/device/K151665
Methodology: https://510kreport.com/methodology