# K120101: Independence Spacer

- Pathway: 510(k) (Special)
- Applicant: Globus Medical, Inc.
- Decided: Mar 27, 2012 after 75 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: 11 generations back to K841189 (1984). 21 ancestors in all.
224 later devices descend from it; 9 cite it directly.
0 of 246 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 1.
- K103382: Intercontinental Plate-Spacer, Globus Medical, Inc. (2011) Summary page 1.

## Most influential descendants
- K143578: SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer (2016), 210 descendants of its own
- K142498: MAGNIFY and MAGNIFY-S Spacers (2015), 175 descendants of its own
- K132559: Monument Spacers (2013), 166 descendants of its own
- K152022: SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer (2017), 149 descendants of its own
- K161223: TransContinental® M Spacers and InterContinental® Plate-Spacers (2016), 117 descendants of its own

## Indications for use
The INDEPENDENCE® Spacer is a stand-alone 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 INDEPENDENCE Spacer is to be filled with autogenous bone graft material and is to be used with three titanium alloy screws, which accompany the implant.

Source page: https://510kreport.com/device/K120101
Methodology: https://510kreport.com/methodology