# K072970: Patriot Spacers

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jan 18, 2008 after 88 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
No predicates in its family tree.
1,094 later devices descend from it; 29 cite it directly.
1 of 1,095 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- P95002: BAK Interbody Fusion System. Number could not be read Summary page 1.

## Most influential descendants
- K093242: Patriot Transcontinental Llif Spacer (2009), 921 descendants of its own
- 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

## Indications for use
PATRIOT TM Spacers (Constitution T M PLIF, Continental T M ALIF, TransContinentalTM LLIF and Signature TM TLIF 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 I spondylolisthesis or retrolisthesis at the involved level(s). PATRIOTTM 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/K072970
Methodology: https://510kreport.com/methodology