# K123231: Caliber Spacers

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jan 18, 2013 after 94 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). 22 ancestors in all.
657 later devices descend from it; 24 cite it directly.
1 of 680 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.
- K113447: Rise Spacer, Globus Medical, Inc. (2012) Summary page 1.
- K080537: L-Varlock, Kiscomedica S.A. (2008) Summary page 1.

## Most influential descendants
- 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
- K160051: NuVasive® Interfixated Interbody System (2016), 396 descendants of its own

## Indications for use
CALIBER® Spacers are interbody fusion devices intended for use in patients with degenerative disc disease. (DOD) 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). CALIBER® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the REVERE® or REVOLVE® Stabilization Systems.

Source page: https://510kreport.com/device/K123231
Methodology: https://510kreport.com/methodology