# K113447: Rise Spacer

- Pathway: 510(k) (Special)
- Applicant: Globus Medical, Inc.
- Decided: Jan 26, 2012 after 66 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: 11 generations back to K841189 (1984). 21 ancestors in all.
691 later devices descend from it; 27 cite it directly.
1 of 713 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102293: Caliber Spacer, Globus Medical, Inc. (2011) Summary page 1.

## Most influential descendants
- K123231: Caliber Spacers (2013), 657 descendants of its own
- K141665: NuVasive CoRoent System (2015), 588 descendants of its own
- K151472: NuVasive CoRoent Lumbar System (2015), 479 descendants of its own
- K150994: NuVasive CoRoent Thoracolumbar Implants (2015), 402 descendants of its own
- K153419: NuVasive CoRoent Thoracolumbar System (2016), 400 descendants of its own

## Indications for use
RISE™ Spacers are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DOD) at one or two contiguous levels of the lumbosacral spine (L-2-S1). DDOD 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). RISE™ Spacers are to be filled with autogenous bone graft material. This device is intended to be used with supplemental fixation, such as the REVERE® or REVOLVE™ Stabilization Systems.

Source page: https://510kreport.com/device/K113447
Methodology: https://510kreport.com/methodology