# K122097: Patriot Spacers

- Pathway: 510(k) (Special)
- Applicant: Globus Medical, Inc.
- Decided: Dec 6, 2012 after 143 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: 12 generations back to K841189 (1984). 23 ancestors in all.
261 later devices descend from it; 14 cite it directly.
1 of 285 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.
- K093242: Patriot Transcontinental Llif Spacer, Globus Medical, Inc. (2009) Summary page 1.
- K102313: Patriot Transcontinental M Spacers, Globus Medical, Inc. (2010) Summary page 1.
- K113447: Rise Spacer, Globus Medical, Inc. (2012) Summary page 1.

## Most influential descendants
- 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 (2016), 210 descendants of its own
- K140411: Altera Spacer (2014), 191 descendants of its own
- K142498: MAGNIFY and MAGNIFY-S Spacers (2015), 175 descendants of its own
- K152022: SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer (2017), 149 descendants of its own
- K161223: TransContinental® M Spacers and InterContinental® Plate-Spacers (2016), 117 descendants of its own

## Indications for use
PATRIOT* Spacers (Constitution® PLIF, Signature® TLIF, Continental® ALIF, Transcontinental® and Transcontinental®' M 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). DDID 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). PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

Source page: https://510kreport.com/device/K122097
Methodology: https://510kreport.com/methodology