# K160597: INDEPENDENCE MIS Spacers

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Aug 29, 2016 after 180 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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). 113 ancestors in all.
111 later devices descend from it; 8 cite it directly.
0 of 225 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082252: Independence Spacer, Globus Medical, Inc. (2008) Summary page 4.
- K120101: Independence Spacer, Globus Medical, Inc. (2012) Summary page 4.
- K110327: LDR Spine Roi-a Interbody Fusion System, Ldr Spine USA (2011) Summary page 4.
- K150643: Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti, Centinel Spine, Inc. (2015) Summary page 4.
- K123045: Brigade Standalone System, Nuvasive, Inc. (2013) Summary page 4.

## Most influential descendants
- K170157: INDEPENDENCE® Spacers (2017), 109 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
- K201087: CORBEL Spacers (2020), 36 descendants of its own
- K203278: INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers (2021), 35 descendants of its own

## Indications for use
INDEPENDENCE® (including INDEPENDENCE® MIS) Spacers interbody fusion devices 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 | spondylolisthesis or retrolisthesis at the involved level(s). INDEPENDENCE® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. The INDEPENDENCE® Spacer is a stand-alone interbody fusion device intended to be used with three titanium alloy screws which accompany the implant. The INDEPENDENCE® MIS Spacer is an interbody fusion device to be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, the INDEPENDENCE® MIS Spacer is a stand-alone interbody fusion device. When used with anchors, the INDEPENDENCE® MIS Spacer is intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (>25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

Source page: https://510kreport.com/device/K160597
Methodology: https://510kreport.com/methodology