# K103382: Intercontinental Plate-Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: May 20, 2011 after 183 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: 10 generations back to K841189 (1984). 20 ancestors in all.
554 later devices descend from it; 13 cite it directly.
1 of 575 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082252: Independence Spacer, Globus Medical, Inc. (2008) Summary page 1.
- K093242: Patriot Transcontinental Llif Spacer, Globus Medical, Inc. (2009) Summary page 1.
- K071795: Nuvasive Coroent System, Nuvasive, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
- K161230: NuVasive Lumbar Interbody Implants (2016), 381 descendants of its own

## Indications for use
The InterContinental Plate-Spacer is an 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 InterContinental Plate-Spacer is to be filled with autogenous bone graft material, and is to be used with two titanium alloy screws which accompany the implant. These devices are intended to be used with supplemental fixation in addition to the integrated screws.

Source page: https://510kreport.com/device/K103382
Methodology: https://510kreport.com/methodology