# K082252: Independence Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Nov 5, 2008 after 89 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: 1 generation back to K072970 (2008). 1 ancestor in all.
576 later devices descend from it; 13 cite it directly.
1 of 578 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072970: Patriot Spacers, Globus Medical, Inc. (2008) Summary page 1.

## Most influential descendants
- K103382: Intercontinental Plate-Spacer (2011), 554 descendants of its own
- K131723: Coroent Single Tab System (2013), 466 descendants of its own
- K140479: Coroent XL-F System (2014), 465 descendants of its own
- K160051: NuVasive® Interfixated Interbody System (2016), 396 descendants of its own
- K153782: NuVasive® Lumbar Interbody Implants (2016), 390 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/K082252
Methodology: https://510kreport.com/methodology