# K170157: INDEPENDENCE® Spacers

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Sep 25, 2017 after 250 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: 18 generations back to K841189 (1984). 169 ancestors in all.
109 later devices descend from it; 6 cite it directly.
0 of 279 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160597: INDEPENDENCE MIS Spacers, Globus Medical, Inc. (2016) Summary page 5.
- K082252: Independence Spacer, Globus Medical, Inc. (2008) Summary page 5.
- K120101: Independence Spacer, Globus Medical, Inc. (2012) Summary page 5.
- P950002: Bak Interbody Fusion System, Zimmer Spine, Inc. (1996) Summary page 5.
- 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, Globus Medical, Inc. (2016) Summary page 5.
- K142498: MAGNIFY and MAGNIFY-S Spacers, Globus Medical, Inc. (2015) Summary page 5.

## Cited in the summary but kept off the family tree
- K142397: Predicate III Guidewire, Lake Region Medical (2014). Our reading of the summary gave K142397, FDA’s number for Predicate III Guidewire (Lake Region Medical). Its FDA name has none of the distinctive words the summary uses for the device it names, “BAK INTERBODY FUSION SYSTEM”. Kept off the family tree. Summary page 5.

## Most influential descendants
- 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
- K201671: A-Link Z (2021), 25 descendants of its own

## Indications for use
INDEPENDENCE® (including INDEPENDENCE® TPS, INDEPENDENCE MIS™, INDEPENDENCE MIS™ TPS, INDEPENDENCE MIS AGX™, and INDEPENDENCE MIS AGX™ TPS) Spacers are 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 1 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. INDEPENDENCE® and INDEPENDENCE® TPS Spacers are stand-alone interbody fusion devices intended to be used with three titanium alloy screws which accompany the implants. INDEPENDENCE MIS™ and INDEPENDENCE MIS™ TPS Spacers are interbody fusion devices intended to be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are 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). INDEPENDENCE MIS AGX™ Integrated Spacer, INDEPENDENCE MIS AGX™ TPS Integrated Spacer, and INDEPENDENCE MIS AGX™ Integrated Ti Spacer are interbody fusion devices that may be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are 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). INDEPENDENCE MIS AGX™ Spacer and INDEPENDENCE MIS AGX™ TPS Spacer are C-shaped, non-integrated PEEK spacers that are intended to be used with supplemental fixation (e.g. facet screws or posterior fixation). When used in conjunction with the INDEPENDENCE MIS AGX™ Integrated Ti Spacer, these devices become the INDEPENDENCE MIS AGX™ Integrated Spacer.

Source page: https://510kreport.com/device/K170157
Methodology: https://510kreport.com/methodology