# K093242: Patriot Transcontinental Llif Spacer

- Pathway: 510(k) (Special)
- Applicant: Globus Medical, Inc.
- Decided: Dec 23, 2009 after 69 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, 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: 9 generations back to K841189 (1984). 18 ancestors in all.
921 later devices descend from it; 15 cite it directly.
1 of 940 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.
- K090899: Depuy Spine Lateral System, Depuy Spine, Inc. (2009) Summary page 1.
- K071795: Nuvasive Coroent System, Nuvasive, Inc. (2007) Summary page 1.

## Most influential descendants
- K102293: Caliber Spacer (2011), 869 descendants of its own
- K113465: Acculif TL Cage (2011), 718 descendants of its own
- K113447: Rise Spacer (2012), 691 descendants of its own
- K121683: Acculif TL Cage (2012), 682 descendants of its own
- K123752: Acculif TL and PL Cage (2013), 676 descendants of its own

## Indications for use
PATRIOT® TransoontinentalTM 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). OIDD 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 PATRIOT® TransContinental® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the PROTEX® or REVERE® Stabilization System.

Source page: https://510kreport.com/device/K093242
Methodology: https://510kreport.com/methodology